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ccrpsorg · 1 year

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2023 Updates for Clinical Research Associates and Clinical Research Monitors

Common clinical trial guidelines used for monitors are designed to ensure the safety and accuracy of the data collected. These guidelines help to make sure that all participants in the trial are treated fairly and ethically, as well as ensuring that the results of the trial will be useful for medical research.

One important guideline is that the monitor must be independent from both the sponsor and investigator. The monitor should have no interest in or influence on the study's outcome, and must have complete access to any documents or records related to conducting the trial. Additionally, they are responsible for ensuring that all protocols are followed correctly, data is correctly recorded and stored, and any adverse events or reactions reported accurately and promptly.

Another key guideline is that monitors must act in accordance with Good Clinical Practice (GCP) guidelines established by International Conference on Harmonization (ICH). GCP outlines procedures for clinical trials involving human subjects so that ethical practices can be maintained throughout a study. It covers many topics including informed consent, protocol review, quality assurance/monitoring, investigator qualification requirements, patient safety procedures, and data verification methods.

Additionally, monitors may use other standards such as The Code of Federal Regulations (CFR), which is used by US Food & Drug Administration (FDA) to regulate drugs; International Committee on Harmonization (ICH) E6R2 ethical guidelines; European Medicines Agency’s Guidelines on Good Clinical Practice (GCP); World Health Organization’s International Ethical Guidelines for Biomedical Research Involving Human Subjects; or local regulations specified by each country’s health ministry.

Overall, these guidelines help to ensure that monitors remain impartial during a clinical trial - this helps to protect participant safety as well as providing reliable data for researchers later down the line.

Clinical research monitors are responsible for ensuring the safety of participants in clinical trials and the accuracy of data collected. In 2023, there have been several updates to guidelines for clinical research monitors that they should be aware of.

The United States Food and Drug Administration (FDA) has released Clinical Trials Guidance Documents that provide advice on the conduct of clinical trials, good clinical practice, and human subject protection. These documents outline the standards that must be met in order to ensure a safe and ethical trial environment.

Clinical research associates (CRAs) play a key role in medical research, ensuring that clinical trials are conducted according to the highest standards of quality, safety and ethics. In light of this importance, the U.S. Food and Drug Administration (FDA) has recently released new guidelines for CRAs conducting clinical trials. These guidelines provide an important framework to ensure that all research is conducted responsibly and ethically while protecting participants’ rights and safety. The FDA’s new guidelines focus on three main areas: data security, participant monitoring protocol, and communication with sponsors.

First, the FDA has established stringent data security measures to protect trial participants’ information during all stages of the trial process. This includes measures such as encryption of sensitive data, physical access control systems for secure areas where information is stored or processed, and regular backups of critical data sets to prevent any potential losses due to cyber-attacks or system malfunctions.

Second, the FDA requires that participation by CRAs in clinical trials include appropriate monitoring protocols designed to minimize risks associated with various trial procedures. This may include frequent communication with study sponsors about changes in protocol or patient status; close observation of trial participants; review and approval of all research documents before their use; scheduling regular safety assessments; and maintaining accurate records of all activities associated with each trial phase.

Finally, CRAs must maintain open communication channels with sponsors throughout the duration of a clinical trial in order to promptly report any changes in protocol or patient status that may require further review or approval from sponsors. Additionally, CRAs need to be trained on how to effectively communicate any necessary updates or potential issues related to regulatory compliance so they can ensure effective oversight over the entire course of a study period.

The FDA's new clinical trial guidelines provide an essential reference point for CRAs responsible for conducting medical research safely and ethically while protecting participants' rights and well-being. With these comprehensive guidelines in place, CRAs now have an even greater responsibility than ever when it comes to ensuring the success of health-related studies around the world.

Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers 3/15/2023

Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products 1/31/2023

Clinical Investigator Administrative Actions — Disqualification 12/01/2022

Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment 10/17/2022

Tissue Agnostic Drug Development in Oncology 10/17/2022

Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials 10/17/2022

Ethical Considerations for Clinical Investigations of Medical Products Involving Children 09/23/2022

Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products 09/08/2022

We must always review the Handbook for Good Clinical Research Practice (GCP), which provides guidance on implementation of GCP standards. Additionally, the International Council for Harmonisation (ICH) has published Efficacy Guidelines which address design, conduct, safety and reporting of clinical trials.

2023 Good Clinical Practice Guidelines for Clinical Research Associates:

Clinical research associates must stay up-to-date on the latest clinical research regulations, guidance documents, and technology advancements in order to ensure ethical and compliant clinical trial management.

Clinical research associates must establish effective communication with all members of the research team to facilitate the exchange of information regarding study updates, timelines, and protocols.

Clinical research associates are responsible for performing accurate data entry into relevant databases or case report forms (CRFs) as part of their role in documenting results from clinical trials.

Clinical research associates must ensure that informed consent is obtained from all participants in accordance with local regulations and international ethical standards.

Clinical research associates must be knowledgeable about relevant In Vitro Diagnostic (IVD) device regulations and requirements for providing evidence of conformity, accuracy, and effectiveness prior to use in a study.

Clinical research associates should create detailed visit plans for each participant in order to maximize the efficiency of visits to investigator sites during a study without compromising data quality or patient safety.

Clinical research associates should conduct regular quality assurance (QA) activities such as source document verification (SDV), query resolution, audit trails, monitoring reports review, reconciliation activities etc., ensuring data accuracy throughout the course of a study period.

During audits or inspections conducted by regulatory authorities or ethics committees, clinical research associates must be prepared to present comprehensive documentation demonstrating compliance with GCP principles and local regulations governing clinical trial conduct.

The European Medicines Agency (EMA) has also released a Clinical Trials Regulation which harmonises processes for assessment and supervision of clinical trials throughout the EU. This regulation outlines requirements to ensure patient safety during a trial as well as evaluation procedures for new drugs or treatments being tested in a trial setting. Finally, The EQUATOR Network provides study protocols such as SPIRIT and PRISMA-P; diagnostic/prognostic studies such as STARD and TRIPOD; case reports such as CARE; extensions; clinical practice guidelines such as AGREE; all aimed at enhancing quality and transparency in health research publications.

In 2022, the US Food and Drug Administration (FDA) released new clinical trial guidelines that emphasize patient safety. The guidelines mandate that all clinical trials must adhere to a rigorous set of standards in order to ensure patient safety and efficacy.

The new guidelines require research teams to obtain written informed consent from participants prior to initiating any study activity. Abuse of animals is prohibited, and investigators are expected to use only those treatments that have shown potential benefit in animal studies. Additionally, researchers must report any adverse events or reactions during the course of the trial and ensure proper follow up care for affected individuals.

Furthermore, the FDA requires that research teams perform rigorous safety monitoring throughout the course of the trial. Regular data analyses and reviews must be conducted to identify potential risks and unexpected results, which must be reported in real time. Additionally, the FDA requires research teams to implement a system for tracking participant adherence to protocols, including collecting data on missed doses, changes in medication regimens, and other protocol violations.

The FDA also mandates more frequent reporting of results throughout the course of clinical trials. They require researchers to share interim results with stakeholders every six months or whenever significant changes occur in study design or purpose. These reports should include key findings as well as basic information about participant demographics and outcomes associated with each treatment arm.

Finally, the FDA has increased their emphasis on transparency by requiring researchers to disclose detailed information regarding sponsoring organizations and conflicts of interest associated with each study before it begins. This includes information related to payments made by sponsors as well as nonmonetary benefits received by investigators or other individuals associated with the trial.

By 2023, additional provisions will be added to these regulations including enhanced requirements related to diversity among participants; strengthened criteria for evaluating ethical considerations such as protection from harm; expanded definitions related to economic conflict-of-interest disclosure; greater emphasis on appropriate risk/benefit ratios; improved reporting of results utilizing standardized metrics; increased focus on study protocol adherence; enhanced data sharing practices; clear criteria for determining when further review is needed due health concerns; specified mechanisms for measuring patient quality-of-life outcomes; increased accountability through stronger recordkeeping systems; enhanced guidance around informed consent forms; improved methods for monitoring compliance; greater attention paid towards reviewing unpublished manuscripts related to clinical trials; expansion of proposed preventative measures targeting financial misconduct issues such as fraud detection systems; improved oversight mechanisms using Artificial Intelligence technologies such as natural language processing (NLP); and additional efforts aimed at improving public understanding around clinical trials through better communication strategies between sponsors and patients alike.

Stay up to date on clinical trials and your annual ICH GCP certification through one of the most comprehensive courses in the industry.

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joshdisbrow0 · 5 months

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Orchestrating Success Unveiling the Dynamics of Pharmaceutical Licensing and Partnerships

In the intricate dance of pharmaceutical development, orchestrating success often requires a harmonious collaboration between industry players. As companies explore the realm of licensing and partnerships to amplify their impact, navigating the complexities with a nuanced understanding of key considerations is crucial. This article unveils the strategic elements that can elevate a pharmaceutical collaboration from a contractual agreement to a symphony of innovation.

Strategic Alignment

The bedrock of a successful partnership lies in strategic alignment. Before diving into collaborations, pharmaceutical entities must ensure that their long-term goals and visions are in harmony. A shared commitment to therapeutic areas, market segments, and overall business strategies sets the stage for a partnership that transcends the transactional and evolves into a strategic alliance with a shared purpose.

Technological Integration

In the era of cutting-edge technologies, the integration of technological capabilities becomes paramount. Pharmaceutical collaborations should assess the potential for synergy in technological platforms, data analytics, and artificial intelligence. Leveraging these advancements can accelerate drug discovery, streamline clinical trials, and enhance overall research and development processes.

Patient-Centric Focus

A transformative shift toward patient-centricity is reshaping the pharmaceutical landscape. Successful collaborations embrace this paradigm by placing the patient at the core of their endeavors. From designing clinical trials with patient input to jointly addressing unmet medical needs, a patient-centric approach enhances the partnership's credibility and contributes to creating more meaningful and impactful therapies.

Global Market Access

Pharmaceutical licensing and partnerships often revolve around expanding market reach. Understanding the intricacies of global markets, including regulatory landscapes, cultural nuances, and healthcare infrastructures, is crucial. Collaborators should strategize to optimize market access, ensuring that their products can seamlessly navigate the complexities of diverse healthcare systems worldwide.

Innovation Ecosystems

Innovation thrives in ecosystems that foster collaboration and idea exchange. Companies entering into partnerships should consider how well they integrate into each other's innovation ecosystems. This includes evaluating research and development pipelines, the potential for co-development initiatives, and the collective ability to adapt to emerging scientific trends.

Ethical and Compliance Standards

Maintaining the highest ethical and compliance standards is non-negotiable in the pharmaceutical industry. Companies must ensure that their potential partners are committed to integrity, transparency, and adherence to regulatory guidelines. Establishing a robust ethical framework safeguards the reputation of the collaborating entities and builds trust with stakeholders and regulatory authorities.

Flexibility in Collaboration Models

The one-size-fits-all approach rarely works in the diverse landscape of pharmaceutical partnerships. Flexibility in collaboration models is crucial, ranging from traditional licensing agreements to more innovative structures such as risk-sharing partnerships or joint ventures. Tailoring the collaboration model to the unique needs and strengths of the partners fosters a dynamic and adaptive relationship.

Talent and Skill Synergy

Collaborations should extend beyond the boardroom and permeate the organizational fabric. Assessing the talent and skills within each organization and identifying areas of synergy can elevate the partnership. Shared expertise in areas such as clinical development, regulatory affairs, and commercialization can streamline processes and contribute to the overall success of the collaboration.

As pharmaceutical companies embark on licensing and partnerships, the dynamics involved go far beyond the ink on a contractual agreement. The orchestration of success requires a holistic approach that considers strategic alignment, technological integration, patient-centricity, global market access, innovation ecosystems, ethical standards, collaboration model flexibility, and talent synergy. In embracing these considerations, pharmaceutical collaborations can transcend the ordinary and create a symphony of innovation that resonates across the industry, bringing about transformative advancements in healthcare for the benefit of patients worldwide.

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vajbyrne · 7 months

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What Family Law Attorneys Do

Family law lawyers can gain early exposure to family law through externships, clinics and other experiential learning opportunities.

Custody and parenting time cases are complex, with states determining child-rearing responsibilities based on a variety of factors. Family lawyers also represent clients in divorce and separation proceedings.

Spousal support is a key component of any divorce case, with courts considering several factors including length of marriage and the ability to work. Family lawyers help prepare legal documents, file court petitions and provide advice to clients.

Child custody and parenting time

When children are involved, custody and visitation are major issues that impact every family. A judge will look at what the child’s needs are and work out a schedule to best meet those needs. It is generally a good idea for both parents to have contact with their children. The schedule might be specific and set dates, or it may be “reasonable parenting time” where the non-custodial parent has weekend or weekday access with the children on a regular basis.

A skilled family law lawyer can help protect your rights and work out the best arrangements for you and your children. Whether it is a divorce, a request for or defense against an order of protection, custody and visitation, or fighting unfair allegations of abuse or neglect, you will need an experienced advocate to help you through this difficult process. Working out the matter outside of court is always a good idea if possible. If it must go to trial, an experienced child custody attorney will also know how to prepare the case for appeal.

Divorce

Divorce is a difficult and emotionally draining process. Family law attorneys help clients navigate this complicated issue and ensure that their client’s rights are protected. Divorce cases often involve complex issues such as property division, child custody and spousal support.

Attorneys whose practice is primarily divorce may still have expertise in other areas of family law such as prenuptial agreements, guardianship or adoption. However, most attorneys whose practice is primarily divorce do not handle a large volume of these other types of cases.

When people think of a divorce attorney, they often imagine a ruthless litigator. In contrast, the image of a family law attorney suggests someone who is more moderate and resolution oriented. Regardless of how they are perceived, both types of lawyers play an important role in helping people through some of the most challenging times in their lives. They do so with vast legal expertise and extraordinary empathy. This is why finding the right lawyer is so important.

Child support

Whether you need representation in a contested divorce or to establish child support payments, a knowledgeable family law attorney can help. Family lawyers often have an intimate knowledge of the state’s laws and procedures, including what judges expect to see in court.

Most states have established child support guidelines that a judge will use to determine the amount of child support payable between two parents. The amount typically depends on the income of each parent and the needs of the child or children involved.

A good New York family lawyer will be familiar with these guidelines and be able to present your case in a way that is likely to gain approval from a judge. He or she will also understand that child support is one of the most important aspects of many families’ lives and work hard to ensure that it is addressed promptly and fairly. They will strive to settle cases through negotiations but will be prepared to take your case to trial if necessary.

Spousal support

Spousal support, also known as alimony, is designed to create financial fairness between spouses after a divorce. It requires the higher earning spouse to pay support to the lower-earning spouse. This can be awarded temporarily while the divorce or legal separation is in progress and then again once the final judgment has been issued.

In New York, courts consider several factors when determining the duration and amount of spousal support. One is the length of the marriage. A judge also looks at the ability of each spouse to earn income. For example, if a person quit his job to grow mushrooms, the court may not award alimony.

A qualified family law attorney can help you navigate a divorce or other family-related legal issues. You can find a reputable lawyer through professional organizations, which often have tools to help you locate an affordable attorney. You can also seek out pro bono assistance or community legal services.

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healthcaretechnologynews · 7 months

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Data Privacy and Compliance in Pharma Data Analytics: Navigating Regulatory Challenges

In the realm of pharmaceuticals, the convergence of data analytics and stringent regulatory requirements presents both promising opportunities and significant challenges as well. As the industry accelerates its adoption of data-driven approaches, ensuring data privacy and compliance with regulations becomes imperative. This blog delves into the critical intersection of data privacy and compliance within pharma data analytics, shedding light on the challenges faced and strategies for navigating this complex landscape.

Write to us at [email protected] to delve into the critical intersection of data privacy and compliance within pharma data analytics, shedding light on the challenges faced and strategies for navigating this complex landscape.

The Promise of Pharma Data Analytics:

Pharmaceutical companies are harnessing the power of data analytics to revolutionize drug discovery, clinical trials, personalized medicine, and post-market surveillance. Analyzing vast amounts of patient data can lead to more precise treatments, optimized trial designs, and improved patient outcomes. However, this potential comes with a responsibility to safeguard patient privacy and adhere to regulatory mandates.

Navigating Regulatory Challenges:

HIPAA and GDPR Compliance: Ensuring compliance is non-negotiable for companies operating in regions covered by the Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR). These regulations stipulate strict guidelines for collecting, storing, and processing patient data, necessitating robust security measures, informed consent procedures, and data anonymization.

Data Anonymization and De-identification: Balancing the need for data analysis with patient privacy often involves anonymizing or de-identifying the data. This process involves removing or altering personally identifiable information (PII) to ensure that individuals cannot be readily identified from the data. However, the challenge lies in finding the right balance between preserving data utility for analysis and protecting privacy.

Consent Management: Obtaining informed consent from patients to use their data for analytics is a cornerstone of ethical data use. Pharma companies must devise transparent consent procedures explaining the scope, purpose, and potential data analysis risks. Consent should be granular, allowing patients to choose the specific types of data usage they're comfortable with.

Cross-Border Data Transfer: In a globalized pharmaceutical landscape, data may be analyzed across international borders. This introduces additional complexities due to varying data protection laws. Adequacy agreements and standard contractual clauses must be considered when transferring data to countries without equivalent privacy regulations.

Data Breach Preparedness: Data breaches can still occur despite stringent security measures. Pharma companies must have well-defined breach response plans in place, including notifying affected individuals and authorities and implementing measures to prevent future breaches.

Strategies for Success:

Collaboration: Close collaboration between data scientists, compliance officers, legal teams, and regulators is crucial. A multidisciplinary approach ensures that analytics projects are designed with compliance in mind from the outset.

Privacy by Design: Implementing privacy-enhancing technologies and practices from the start of any data analytics project can mitigate risks. Companies can proactively address compliance challenges by embedding privacy into the design of systems and processes.

Continuous Training: Keeping employees updated on evolving regulations and privacy best practices is essential. Regular training sessions can foster a culture of data privacy awareness and responsibility.

Third-Party Vendors: Due diligence is necessary when outsourcing data analytics tasks to third-party vendors. Partners must meet stringent privacy and security standards to maintain compliance.

Conclusion:

Pharmaceutical data analytics accounts for an immense potential to transform the market, but it must be wielded responsibly. Navigating the regulatory challenges requires a comprehensive understanding of global data privacy laws, a commitment to patient confidentiality, and a proactive approach to compliance. As the pharmaceutical landscape evolves, the harmonious integration of data analytics and regulatory compliance will be the cornerstone of success, fostering innovation while safeguarding patient trust.

Visit our website now: https://www.anervea.com/

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healthcaretoday1 · 7 months

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Data Privacy and Compliance in Pharma Data Analytics: Navigating Regulatory Challenges

Read more: https://www.anervea.com/data-privacy-and-compliance-in-pharma-data-analytics-navigating-regulatory-challenges

The Promise of Pharma Data Analytics:

Navigating Regulatory Challenges:

Strategies for Success:

Third-Party Vendors: Due diligence is necessary when outsourcing data analytics tasks to third-party vendors. Partners must meet stringent privacy and security standards to maintain compliance.

Conclusion:

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outweek30 · 5 years

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FDA Approves AIDS Blindness Drug Speeded Process Skips Clinical Trials

WASHINGTON [July 10, 1989] — The Food and Drug Administration (FDA) granted final approval status to ganciclovir, a drug used to treat AIDS-related blindness, on June 26 [1989], bringing to four the number of FDA-approved AIDS treatment drugs, The drug's release marks the first time in nearly 25 years that the FDA has granted commercial approval to a drug without what is called "pure scientific evidence" from a full-scale clinical trial.

[...]

The approval of ganciclovir has largely been credited to the work of the New York AIDS Coalition to Unleash Power (ACT UP/NY). Through a series of carefully crafted actions and negotiations, it enlisted the support of the community 'and extracted the approval of the drug from a controversial study in which it was bogged down.

An FDA panel set to recommend approval of the drug in late 1987 shocked the AIDS and medical communities when, over the objections of the two ophthalmologists on the board, the panel voted against approval.

Earlier this year, after extensive research and meetings with physicians, ACT UP commandeered an FDA oversight panel and grilled FDA spokesperson Ellen Cooper on the stymied approval status of the drug.

After the meeting, three ACT UP members met with National Institute on Allergies and Infectious Diseases Director Dr, Anthony Fauci to enlist his support on the approval of the drug, while other activists conducted a demonstration at the NIAID offices in Bethesda.

After his meeting with ACT UP, Fauci discussed the drug with [FDA commissioner Frank] Young, and scheduled another vote on the approval of the drug for May 2 [1989], ACT UP held a silent demonstration during that meeting at which the drug was finally approved.

"I would say this is our biggest victory to date, hands down, stated Peter Staley of ACT UP. "Instead of 'pure scientific data' [before approval], [the FDA] had 100 percent agreement on anecdotal data, basically from clinicians on compassionate use. We've been arguing all along that that says something; that common sense dictates that if every patient — and there are over 3,000 patients that have used the drug — and every doctor that has used the drug, to a tee, says it works — and nobody says it doesn't work — then we have a drug ready for release. ACT UP was pushing that from the beginning."

AIDS activists are also concerned with the pricing of the drug, which will cost patients $29 a treatment. If administered in accordance to FDA guidelines, the drug could cost patients up to $10,585 a year, well over the high price of the costly antiviral AZT.

"It's quite an expensive little treatment," added Staley. "This is not an expensive drug to make. This is not an AZT."

Staley added that ACT UP will be working with ACT UP chapters in California to mount pressure on [manufacturer] Syntex for cost data and lower prices for the drug.

[...]

It is the fourth drug to be granted the special, experimental status, which was created in response to pressure from AIDS advocates to speed up patients' access to new treatments. The other three drugs are aerosolized pentamidine and ganciclovir, which have since been fully approved, and trimetrexate, a pneumonia drug.

— Cliff O’Neill, OutWeek Magazine No. 3, July 10, 1989, pp. 21–23.

#outweek #issue 3 #lgbt history #hiv aids #act up #drug pricing #aids research #fda #ganciclovir #cmv #peter staley #ellen cooper #niaid #anthony fauci #frank young #syntex #news #cliff o'neill

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shahramkabiri · 3 years

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Clinical Free trial Technological and Budgeting Have an effect on

The existing specialized medical medication and trial run regulatory processes have lagged beneath progress in medical exploration. Regulatory consent draws on evidence of efficiency and wellbeing collected from pivotal tests. Most experts agreed upon that conventional method to substance improvement comprise a blunt system when a better on target play with it could be enough rather than a a specific-measurement-matches-all tactic and that is worthless and wasteful.

Consistent with research studies handled by New The united kingdom Diary of medicine, virtually 9 in fifteen clinical trials will not speak to FDA needs and therefore fail to make it to the markets. Assignment does not work out once they usually do not deal with endpoints. Lack of efficiency and challenging process ought to be the top cause of disaster. To undo this fashion, output will be focused in direction of the horrible predictive capability of the latest experimental sugar land primary care

Medical clinic trial run takes on a leading role in pill progress and enhancement in technological innovation that include prescription drug placement, healing concentrate on, and medicine effectiveness forecast are helping out analysts and drug enterprises in drug production.

Classic tests have preset parameter that may be figured out in advance and continue being steady around out of processes. A specific assuring way to modernizing clinical trials and maximizing performance is actually adaptive trial offers which permit without a doubt guidelines for example , sample overall size and procedures plan to be customized or change on interim success.

The primary difficulty simple fact that expenditure in scientific scientific studies are diminishing as government and stakeholders tightened their financial constraints. The clinical trial period detects again in any budgetary squeeze, as crucial sponsors profits stabilize and cost pursue to escalate. Prescription drug and healthcare-equipment businesses have been intent on cutting finances. Trim agreement negotiations ought to be the usual these days, no recruit is walking with an income burning pit in his or her allowance and quite a few are responding to mandate to conserve total price by requiring CROs to give unlikely very competitive finances which have been disastrous. With tightened finances, quite short-sightedness is one of the select during the day and as a result, both of those sponsors and CROs good reputation endured.

Sawing to return drastically or unwillingness to sufficiently account a task will create a inadequate end result. This basic strategy is unrealistic and unsustainable. You must remember that centering primarily on concise-words course of action is going to be damaging of the long term. Wealth will unquestionably develop if eco friendly explore weather conditions are crafted.

We have seen ever-increasing exertion in making use of techniques to simplify process and enhancement efficiency in clinical analyze. The application of technological advances is empowering review trained professionals by helping to them to make a final decision consistent with subsequent data. With the assistance of concept, organisations are eliminating cost you and accelerating evaluation processes. Science makes for accrual of data more efficiently and documents are disseminated instantly. This can lead to the best investment increasingly being achieved on process, affected person recruiting, and trial period web-sites.

Here is the set of technologies impacting numerous studies straight away

Financial risk Dependent Supervision (RMB)

Specialists use chance based upon checking to concentrate on and focus on products, determine pitfalls referring to level, essential safety of condition and subject areas of clinical demo information. Risks primarily based tracking (RMB) can feature centered watching or brought on supervising and lowered cause record verification (SDV).

Traditionally, provider facts verification (SDV) turned out to be made completely using on-information site watching, a labor intense address. Lessened SDV limits the measure of SDV around the evaluation, web page and theme amount.

The hunt for better main easy methods to take care of clinical studies has recognized chance centred supervision which tries to deal with sources without need of limiting on specialized medical level.

The factors of process complying, info strength, and sufferer wellbeing etcetera. results how assets are used.

The effect of technological innovations in risks based monitoring is profound and right now in finance industry is clinical demo relief techniques (CTMS) and isolated statistics obtain (RDC) which may enable risk dependent keeping track of machine. Some tools yet guidance manually operated revealing and typing in of medical trial details, for this reason, you will discover a will need to set-up better solid techniques for flagging and alerting reports effortlessly, these warnings are produced for informing men and women who really should try to take action when a challenge comes up.

Depending on Medidata, the cost of onsite watching is approximated at 28.7Per cent of understand finances and plan organization at 26.47Per cent. In moving about to RMB, watches can shell out their time better judiciously reducing purchase price.

Electronic digital Trial offer Expert Report

In biopharma industry, all agency associated with professional medical trial run keeps a trial professional computer file made up of a bunch of 1000 web sites of regulatory forms required for each scientific test.

Having a paper-established or hybrid test learn record machine to control a huge number of specialized medical forms, systems and chores are vast and could result in faults or misread which is able to hurt scientific trial run and put it at risk for noncompliance.

Agencies consistently employed a business Blog posts Therapy Machine (ECM) to regulate medical demo regulatory files. The ECM based upon eTMF brings computerized tricks todirectory and archive, and review on papers and articles and other content.

To eradicate old fashioned paper from the local specialized medical trial period examine, automated signing implementing digital signatures from affirmed users has been utilized. Internationally, most cities for example the US as well as countries in EU are taking virtual signatures instead of damp signatures in so doing eliminating the necessity of examined files.

A digital demo expert data (eTMF) comes with a powerful foundation to documents relief allowing investigation associates to achieve a simple knowledge necessary to correctly manage professional medical trials and speedup period to current market. Electric official document maintenance systems are used from a solid rate when it becomes fundamental to operation productivity, reduced biopharma products growth timeframes, and cost lowering.

eSource

In 2013, the FDA relieve its Tips Papers on Electronic digital Root Knowledge in Professional medical Investigations, consequently learning and sponsors internet websites had been making use of and taking on eSource as a general technique for documenting documents in numerous studies.

The concept of automated useful resource (eSource) could be a clear out approach -- to capture or processes reference details digitally, this knowledge leave out the cause data files that was caught in writing and transcribed into an electronic data base. In eSource, the cause info attribute as well would have to be electric powered.

The benefit of eSource is obvious so the FDA supported it seeing that it will likely be useful in: assisting valid-time entering of automated source info for the duration of topic area trips, takes out the desire to duplicate files, makes it possible for accuracy and precision and completeness of data by means of electronic prompts for irregular and lost files and minimizes the possibility for transcription errors.

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phgq · 3 years

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PH already in ‘advanced stage’ of deals with 5 vaccine firms

#PHnews: PH already in ‘advanced stage’ of deals with 5 vaccine firms

MANILA – National Policy Against Covid-19 chief implementer and vaccine czar, Secretary Carlito Galvez Jr., on Tuesday said the government is finalizing the supply agreements with five pharmaceutical firms hopefully by end-February.

“Sa ngayon po, ang supply agreement na inaayos po natin [ay] 'yung sa lima (So far we are finalizing five supply agreements), we are on the advanced stage already on the negotiation,” Galvez said at a Laging Handa press briefing.

Galvez said he cannot reveal the vaccine brands yet as it is bound by the confidential disclosure agreement (CDA).

“We are expecting this coming end of [the] month of February ay matapos na lahat ng details ng supply agreement (that all the details of the supply agreement will be finalized),” he said. "We have already completed the term sheets of the five vaccine companies and we were able to secure 108 million doses."

The country has also secured 40 million doses of vaccine from the Covax facility, he added.

"We are now preparing for the supply agreements and finalizing all the contract for 148 million doses by mid of February 2021," he said.

Galvez said the government will implement the initial vaccination campaign or a so-called "mini-rollout" from February to March this year.

"For first quarter with limited available doses, we intend to prioritize the healthcare workers to preserve our healthcare system and government essential institutions including the uniformed personnel," he said. "For second quarter, we will build vaccination confidence by protecting our vulnerable sectors, the poor communities, including economic front-liners in accordance with WHO (World Health Organization) and DOH (Department of Health) guidelines."

The massive nationwide rollout will be done in the third quarter, he added.

Galvez said the government targets to inoculate 50 to 70 million Filipinos to achieve herd immunity.

Meanwhile, Galvez said the possible arrival of some 117,000 doses of Pfizer vaccines will be on Feb. 20, which will be delivered in one tranche under the sealed deal with the Covax facility.

Meanwhile, around 5,500,s to 9,290,400 doses of AstraZeneca vaccines will be delivered on the first and second quarter of this year.

"This Covax allocation is very timely since the main recipients of these vaccines are our healthcare workers and front-liners in the different priority and affected regions," he said.

On the other hand, Galvez cited the positive results of the clinical trial conducted by drugmakers Novavax and Johnson&Johnson (J&J).

"We have also positive results of the clinical trials of Novavax and Johnson&Johnson which can increase global capacity to 3 billion. We have a total of 40 million orders with Novavax and also with J&J next generation technology of single shot therapy," he said. (PNA)

***

References:

* Philippine News Agency. "PH already in ‘advanced stage’ of deals with 5 vaccine firms." Philippine News Agency. https://www.pna.gov.ph/articles/1129324 (accessed February 03, 2021 at 12:32AM UTC+14).

* Philippine News Agency. "PH already in ‘advanced stage’ of deals with 5 vaccine firms." Archive Today. https://archive.ph/?run=1&url=https://www.pna.gov.ph/articles/1129324 (archived).

#Philippines #News #Filipino #Pinoy #Tourism #Politics #Culture #Editorial #Environment #Society #History

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kennethresearch · 3 years

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Global Clinical Trial Support Services Market By Industry Research, Supply, Size, Share and Prospects 2021

Clinical Trials researches involve researches done on people. It tests whether a particular procedure or a drug is safe and how well it works. They are designed to improve health and quality of life. Clinical Trial Support Services is a resource that standardize clinical and administrative procedures to conduct human research. It does so ensuring that the research withstands any legal scrutiny and follows the clinical practice guidelines. The following services are provided by Clinical Trial Support Services to the Clinical Investigators: Patient Recruitment, Clinical Research education and training, Clinical trial data management, Clinical research nurse and clinical research coordinator services, Financial services, including invoicing of research sponsors, processing of sponsor payments and payment of study-related expenses, Regulatory submissions to regulatory Health body in the country, including Clinical Trial Applications, Review and negotiation of confidential disclosure agreements, Negotiation of contracts and study budgets, Preparing and submitting ethics applications, Preparing and submitting applications for health region approval, Preparation and processing of regulatory documents, blinding of study drug, and more.

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Market Dynamics

The array of new diseases that we are recognizing every day, and our quest to find the cure for the same are driving the need for newer drug development which in turn is driving the need for clinical trials hence the need for clinical trial support services is on a rise. But increasing amount of investment during the entire process of the trial i.e. right from the patient recruitment to the analysis proves to be hindrance in its growth.

Market Segmentation

The Market has been segmented on the basis of Clinical Trial Cycle which includes: Pre-Clinical, Phase I, Phase II, Phase III. The Pre-Clinical includes: Biomarker Discovery/Development, Assay Design and Development for Research Assay, Clinical Trial Strategy Design to Include Diagnostic. Phase I includes Early-Phase Patient Screening, Sample Collection Management, Data Management Assay Redesign, if Necessary, Pre-Sub Meeting (IND/IDE), Assay CLIA Validation for Clinical Trial Assay. Phase II includes Regulatory Support for IDE Process, Target Patient Population Identification, Sample Collection Management, Data Management, Clinical Trial Testing Services Under CLIA Guidelines, CMO Identification for Research Use Only Kit. Phase III comprises of PMA, NDA Submission , Drug Approval, Global Diagnostic Manufacturing and Commercialization Strategy.

Regional/Geographic Analysis

The United States and Canada in North America; China, Japan, India in Asia-Pacific; Germany, UK, France, Italy and Russia in Europe; Brazil in South America have the largest market in their respective regions.

Key Players

Some of the major players in the market include Alcura Health, Quintiles, Parexel, Pharmaceutical Product Development, LLC, Covance, ICON Plc. Report ContentsRegional AnalysisReport Highlights

Market segments

Market Drivers, Restraints and Opportunities Market Size & Forecast 2016 to 2022 Supply & Demand Value Chain Market - Current Trends Competition & Major Companies Technology and R&D Status Porters Five Force Analysis Strategic and Critical Success Factor Analysis of Key Players

About Kenneth Research

Kenneth Research is a reselling agency providing market research solutions in different verticals such as Automotive and Transportation, Chemicals and Materials, Healthcare, Food & Beverage and Consumer Packaged Goods, Semiconductors, Electronics & ICT, Packaging, and Others. Our portfolio includes set of market research insights such as market sizing and market forecasting, market share analysis and key positioning of the players (manufacturers, deals and distributors, etc), understanding the competitive landscape and their business at a ground level and many more. Our research experts deliver the offerings efficiently and effectively within a stipulated time. The market study provided by Kenneth Research helps the Industry veterans/investors to think and to act wisely in their overall strategy formulation

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guitarpanda8 · 5 years

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Insights Daily Current Affairs + PIB: 13 April 2019

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Insights Daily Current Affairs + PIB: 13 April 2019

Relevant articles from various News Papers:

Paper 3:

Topics Covered:

Energy and pollution related issues.

India stares at pile of solar e-waste

What to study?

For Prelims: Solar Power potential and technologies used to store solar power and waste generated therein.

For Mains: Solar e- waste- extent, concerns, effects and measures needed.

Context: By 2050, India will likely stare at a pile of a new category of electronic waste, namely solar e-waste. India’s PV (photovoltaic) waste volume is estimated to grow to 200,000 tonnes by 2030 and around 1.8 million tonnes by 2050.

What’s missing?

Currently, India’s e-waste rules have no laws mandating solar cell manufacturers to recycle or dispose waste from this sector.

India is poorly positioned to handle PV waste as it doesn’t yet have policy guidelines on the same.

A lack of a policy framework is coupled with the fact that even basic recycling facilities for laminated glass and e-waste are unavailable. Despite the e-waste regulation being in place for over seven years, only less than 4% of estimated e-waste is recycled in the organised sector as per the latest estimates from the Central Pollution Control Board.

What constitutes Solar e- waste and concerns associated?

Solar modules use potentially hazardous materials, including lead compounds, polymers and cadmium compounds. If disposed of in an inappropriate way, potential leaching of those hazardous materials can have negative environmental and health impacts.

For instance, leaching of lead has huge environmental impact including loss in biodiversity, decreased growth and reproductive rates in plants and animals, and several other health hazards like adverse impact on kidney function, nervous, immune, reproductive and cardiovascular systems.

Need of the hour:

Specify liability and responsibility of each stakeholder for waste management and treatment.

Mandate module manufacturers to use environmentally sustainable design and materials with end-of-life in mind.

Lay down standards for PV waste collection, treatment and disposal.

Encourage mutual recycling responsibility agreements between module suppliers, project developers and power purchasers.

Undertake regular surveys of recycling facilities to understand technology and capacity levels. Identify investment and technical requirements for dedicated PV recycling facilities with focus on high-value recovery.

Way ahead:

India is among the leading markets for solar cells in the world, buoyed by the government’s commitment to install 100 GW of solar power by 2022. So far, India has installed solar cells for about 28 GW and this has been done largely from imported solar PV cells. Therefore, the time is ripe for the country to put in place a comprehensive policy to address the issues.

Sources: the hindu.

Paper 2:

Topic covered:

India and its neighbourhood- relations.

Bilateral, regional and global groupings and agreements involving India and/or affecting India’s interests

Effect of policies and politics of developed and developing countries on India’s interests, Indian diaspora.

China’s BRI

What to study?

For Prelims: Key features of BRI.

For Mains: India’s concerns, ways to address them and global implications of the project.

Context: Malaysia will resume work on the multi-billion dollar East Coast Rail Link (ECRL) after months of negotiations with the China Communications Construction Company (CCCC) and the Chinese government brought the cost down by a third. China is building a deep-sea port on Malaysia’s east coast and the railway is a key link in its Belt and Road Initiative.

What is BRI?

BRI consisting of the land-based belt, ‘Silk Road Economic Belt’, and ‘Maritime Silk Road’, aims to connect the East Asian economic region with the European economic circle and runs across the continents of Asia, Europe and Africa.

BRI is China’s ambitious project announced in 2013. It covers about 65% of the world population, 60% of the world GDP and over 70 countries in six economic corridors.

China is spending almost $1 trillion to revive and renew the overland and maritime trade links between China, Europe, West Asia, and East Africa through construction of modern ports linked to high-speed road and rail corridors.

India’s concerns with BRI:

India argues that the BRI and China-Pakistan Economic Corridor project violates its sovereignty because it passes through the part of the Pakistan-occupied Kashmir that belongs to India.

Debt trap: BRI projects are pushing recipient countries into indebtedness, do not transfer skills or technology and are environmentally unsustainable.

China is planning to extend the CPEC to Afghanistan. Meanwhile, Maldives, Nepal, Myanmar and Sri Lanka are eagerly pursuing potential BRI projects.

Through OBOR, China is countering the strategies of India in North East region and is promoting its greater presence in North East India, part of which China claims as its own territory. This may have a security impact on India.

Tense bilateral relations with China, deep mistrusts and India’s growing concerns over Chinese hegemonic intentions in South Asia and Indo-Pacific region make it practically unlikely that India will ever consider joining this project.

Military deployment: The fact that the Chinese have begun to deploy 30,000 security personnel to protect the projects along the CPEC route makes it an active player in the politics of the Indian sub-continent. Clearly, this is a case of double standards.

Sources: the hindu.

Mains Questions: Why is India not part of the Belt and Road Initiative (BRI)? Does India’s absence matter to China? Critically examine.

Paper 2:

Topics covered:

Statutory, regulatory and various quasi-judicial bodies.

Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

Central Drugs Standard Control Organisation (CDSCO)

What to study?

For Prelims: CDSCO- key facts, about PvPI.

For Mains: Misuse of various drugs and the need for stringent provisions to prevent their misuse.

Context: The Central Drugs Standard Control Organisation (CDSCO) has asked commonly-used antibiotics manufacturers to ensure its details be made available to the general public. This decision was taken considering directives from the National Co-ordination Centre of the Pharmacovigilance Programme of India (PvPI).

What is Pharmacovigilance Programme of India (PvPI)?

The PvPI was started by the Government of India on 14th July 2010 with the AIIMS New Delhi as the National Coordination Centre for monitoring Adverse Drug Reactions (ADRs) in the country for safe-guarding Public Health.

Pharmacovigilance is defined as the science relating to the detection, assessment, understanding and prevention of adverse effects, principally long term and short term adverse effects of medicines. The CDSCO has a nation-wide Pharmacovigilance Programme for protecting the health of the patients by promising drug safety.

The Programme is coordinated by the Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC).

About CDSCO:

The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.

Functions: Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

Sources: the hindu.

Paper 2:

Topics Covered:

Effect of policies and politics of developed and developing countries on India’s interests, Indian diaspora.

Legislation to strengthen US-India strategic partnership

What to study?

For Prelims and Mains: Key features and significance of the bill, implications if encated, overview of NATO.

Context: US lawmakers introduce new legislation to strengthen US-India strategic partnership- The bill H R 2123.

Implications:

If enacted, the new bill would ensure that the US State Department treats India as a NATO ally for the purposes of the Arms Export Control Act.

The law would send a powerful signal that defence sales to India should be prioritised according to US-India Strategic Partnership Forum, which had worked on this important legislation.

The legislation bolsters national security and helps ensure full alignment between the Department of Defence and the Department of State.

Need:

India is the world’s largest democracy, a pillar of stability in the region and has shown strong commitments to export control policies. This adjustment to US law will further allow the US-India partnership to flourish in line with the US’s security commitment to the Indo-Pacific region.

Background:

The National Defense Authorization Act (NDAA) for fiscal 2017 included special language recognising the unique US-India defence relationship that designated India as a “Major Defence Partner” of the United States. The language seeks unique consideration for trade and technology sharing with India and increased attention and support to advance this relationship in the areas of defence trade and technology sharing.

To fulfil the spirit and intent of the NDAA 2017, the US-India Enhanced Cooperation Act would amend the Arms Export Control Act to put India on par with NATO allies and Israel, South Korea, New Zealand, Australia and Japan.

Sources: bs.

Mains Questions: In the light of designation of India as “Major Defence Partner” by the US, do you think India’s recent behaviour with Pakistan and Afghanistan is upholding regional peace in South Asia? Critically comment.

Facts for Prelims:

Russia’s highest civilian award for PM:

Russia’s highest civilian award – the “Order of the Holy Apostle Andrew the First,” will be awarded to PM Narendra Modi for his work on bilateral ties.

Eligibility: The Order of the Holy Apostle Andrew the First is awarded to prominent government and public figures, prominent representatives of science, culture, art and various sectors of the economy for “exceptional services that contribute to the prosperity, greatness and glory of Russia”.

It was first awarded by former Russian Tsar ‘Peter the Great’ in 1698 and subsequently discontinued. In 1998, former President Boris Yeltsin reinstated the honour by a presidential decree.

Previous recipients include Chinese President Xi Jinping, and presidents of Azerbaijan and Kazakhstan, former Soviet leader Mikhail Gorbachev and author Aleksandr Solzhenitsyn.

New early human species found: Homo luzonensis:

Context: Researchers have unearthed an unknown human species that lived on an island in Philippines some 50,000 years ago– Homo luzonensis.

The newfound species is named Homo luzonensisin honor of Luzon, the island where the mysterious beings lived during the late Pleistocene epoch, more than 50,000 years ago. They were less than four feet tall.

Though luzonensisis short like the hobbit, it shares features with a number of other ancient human relatives.

It has curved foot and finger bones like Australopithecus(a genus that includes the famous Lucy); premolars that have characteristics similar to those seen in Australopithecus, Homo habilis and Homo erectus; and small molars that look like those of modern humans, or Homo sapiens.

India to be Guest of Honour at ADIBF 2019:

Context: India will be the Guest of Honour country at the 2019 Abu Dhabi International Book Fair (ADIBF) to be held during April. The fair aims to highlight the UAE’s rich heritage, and showcase its authenticity, cultural and literary output. This will be the 29th edition of the Abu Dhabi International Book Fair.

Summaries of important Editorials:

Jallianwala Bagh massacre: ‘Deep regret’ is simply not good enough:

Source: https://www.thehindu.com/opinion/op-ed/deep-regret-is-simply-not-good-enough/article26810058.ece.

What happened?

On April 13, 1919, Baisakhi day, following unrest in Amritsar after protests against the Rowlatt Act, Brigadier General (temporary rank) Reginald Dyer took a strike force of 50 rifles and 40 khukri-wielding Gurkhas into an enclosed ground, Jallianwala Bagh, where a peaceful public meeting of 15,000-20,000 was being held.

The firing of 1,650 rounds was deliberate and targeted, using powerful rifles at virtually pointblank range. Eyewitness accounts and information collected by Sewa Samiti, a charity organisation point to much higher numbers. Non-Indian writers place the number killed at anything between 500 to 600, with three times that number wounded.

Post incidence events – More was to follow after the proclamation, two days after the massacre, of Martial Law in Punjab: the infamous crawling order, the salaam order, public floggings, arbitrary arrests, torture and bombing of civilians by airplanes — all under a veil of strictly enforced censorship.

After calls for an investigation, including by liberals in Britain, a Disorders Inquiry Committee, soon to be known by the name of its Chairman, Lord Hunter, was set up.

Recent responses by the Britain:

British Prime Minister Theresa May finally came out with: “We deeply regret what happened and the suffering caused.” However, the country has refused to formally apologise. Britain’s refusal to squarely apologise for the Jallianwala Bagh massacre is expected but disappointing.

What this means?

Deep regret is all we may get instead of the unequivocal apology that is mandated. The expectation could be that time will add more distance to the massacre, making these calls for apology increasingly an academic exercise. The fact remains that there are many ways to heal a festering wound between nations, as Canada’s apology for the Komagata Maru shows; clever drafting is not one of them.

Nine from outside the IAS set to become joint secretaries in government:

Context: In a move that was widely debated inside and outside the government for a year, the Union Public Service Commission (UPSC) has announced the results of nine lateral hires on contract at the level of joint secretary in various departments and ministries. The move is a tipping point and marks a breach in the hegemony of the IAS.

Background:

In 2014, the Centre had mooted the idea of allowing lateral entry from academia and the private sector at the joint-secretary level. Initially 10 such lateral entries were to be selected and had drawn criticism from the serving and retired members of the Indian bureaucracy.

Rationale behind this move:

The recruitments have been done in a bid to infuse domain expertise in key government departments and is aimed at bringing in specialized talent in various government departments, contributing to better governance.

Why this is a good move?

Earlier experiences showed good results: Lateral entry has been used in the past to harness top talent from outside the civil services. Mr. Manmohan Singh, Nandan Nilekani, Ahluwalia etc served at various positions in the government and have showed promising results on ground.

Helps in getting private sector expertise: Various private sector experts have also been appointed as officers on special duty, ranked between under-secretary and secretary, to ministers. Institutionalising lateral entry, thus, makes it easier for the country to benefit from private sector/non-UPSC talent.

Deals with vacancy issue as well: The move will also address the drying up of the talent pool at the top level as there is an overall shortfall of about 20% in just IAS officers in 24 state cadres. The 2016 BS Baswan committee report pointed out that many large states suffer from a pronounced deficit of IAS officers, leading to their reluctance to depute officers for central posting.

Lateral entry will also address many structural problems the present system suffers from: The seniority criteria in promotions has meant many talented lower ranked officers take a long time to get appointed to posts where their skills could have significant impact in the immediate run.

Focuses on merit: While the education threshold for eligibility in the current notification is set at the graduate-degree level, higher qualifications will be an advantage. The call is for outstanding individuals with expertise in the relevant fields.

Specialists: The move could be a significant step towards fulfilling the longstanding need for domain specialists in positions crucial to policy-making and implementation of government schemes. Specialists coming from outside are likely to bring fresh ideas and help improve outcomes.

The idea is criticized due to the following reasons:

Lateral entry system is a disruption as there is a risk that due process might not be followed and ill-qualified, political appointees will land up in senior positions of the government and hurt public interest.

Lateral entry does open the risk and prospect of powerful corporate groups placing their men in key positions of government.

Also people who are recruited in this way might lack ground experience and also have little idea about the administrative leviathan.

Mains Questions: Lateral entry in government at Joint Secretary level comes not a day too soon. Critically analyze.

Source: https://www.insightsonindia.com/2019/04/13/insights-daily-current-affairs-pib-13-april-2019/

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jobisitejobs · 5 years

Text

Contracts & Grants Pricing Regional Lead - ASPAC - Singapore

Responsible for the development and analysis of fair market value pricing for clinical trial agreements including benchmarking fees and drafting and finalizing financial exhibits to clinical trial agreements. The lead will assist with training of staff, facilitating clear and concise communications and assist PAs with resolution of pricing, contracting and study related issues. In addition, the Pricing lead will provide project management and oversight to internal and external stakeholders as required and support to the clinical team in the budgeting, pricing, planning, execution and control of contracts. RESPONSIBILITIES:

Analyze requirements and translate into appropriate pricing, budgets and contracts for clinical trial agreements and other relevant legal documents.

Review all study specific tracking requirements for accuracy and completeness as well as delivering against pricing cycle time targets

Analyze investigator grants for fair market value aligned with regional knowledge and the J&J pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information.

Provide specialized support and guidance on negotiations in clinical trial agreements, informed consent forms and other ancillary contract documents, as required.

Translate clinical trial protocol requirements into fair market value pricing/budget milestones.

Determine potential needs for budget revisions and related contract amendments and manage the amendment pricing lifecycle. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.

Provide guidance to CROs contracted to negotiate CTAs globally, inclusive of training and supervision to ensure adherence to timelines/targets.

Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.

Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures.

Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.

Adhere to SOPs, ethics and departmental compliance as determined by departmental management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and applicable corporate processes.

Comply with requests from QA and auditors.

Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Participate in and/or lead the approval escalation of grants as appropriate.

Other duties may be performed as assigned.

Qualifications

Bachelors degree in an appropriate scientific or business discipline.

At least 6 years experience and/or equivalent competencies in a pharmaceutical industry/clinical research environment.

Must have a working knowledge of the clinical development process with pricing/budgeting or negotiation and contract experience.

Must have experience working in IMS GrantPlan system or Medidata Grants Manager system.

Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.).

Working knowledge of PCs (MS Office suite at a minimum) and database management

Excellent communication skills (both oral and written).

Advanced fluency in English is required.

Ability to work effectively with cross functional teams.

Must demonstrate ability to work in a fast-paced environment and to work independently.

Previous experience working with virtual teams preferred.

Strong initiative and proven self-starter.

Strong and proven negotiation and problem resolution skills.

Primary Location Singapore-Singapore-Singapore- Organization Johnson & Johnson Pte. Ltd. (8435) Job Function Procurement Requisition ID 1805690491W Contracts&GrantsPricingRegionalLead-ASPAC-Singapore from Job Portal https://www.jobisite.com/extrJobView.htm?id=368101

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gosupplychain2016 · 6 years

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Is any Brexit outcome a no-win for manufacturers?

Whatever “outcome” Brexit delivers in March 2019 it will undoubtedly have a huge impact on manufacturing supply chains in the UK. Manufacturing accounts for about ten per cent of the UK’s GDP, and 44 per cent of the UK’s exports. There is still no clarity about whether a negotiated deal is possible. If there is “no deal” it would mean that trade would begin to be governed by World Trade Organisation rules, where tariffs and customs checks will apply. Manufacturers in the automotive and pharmaceutical industries are understandably very concerned and have already taken certain steps to mitigate potential risks.

Brexit: All you need to know about the UK leaving the EU

Let’s look at the possible scenarios and how they might impact the manufacturing industry:

Scenario 1 The UK leaves the EU customs union and is able to make its own trade agreements with non-EU countries. This is the scenario in which the UK would be like Norway, outside the customs union, but in the single market and in a free-trade area with the EU. This situation is unlikely based on current UK policy.

Scenario 2 The UK leaves the EU single market as well as the customs union and applies its own regulatory rules. This is loosely labelled a “hard” Brexit. This scenario will give rise to additional border costs and delays as the EU will need to have customs checking mechanisms to ensure that imports from the UK satisfy EU rules, and vice versa. The UK would remain in a free trade area with the EU whereby participating nations develop their own rules.

Scenario 3 The UK fails to maintain free trade with the EU and with all the 67 countries with which the EU (including the UK) currently has free trade agreements. The UK will trade on World Trade Organisation terms with all countries. This is called the WTO or no-deal scenario.

Sussex University’s Trade Policy Observatory has estimated the possible effect on UK manufacturing of these three scenarios. In each case, they found that Brexit will lead to a decline in trade and a decline in output, with these effects being greatest in Scenario 3. They estimate that should this come into play, total exports will fall by almost 20 per cent and up to 70,000 jobs could be directly at risk in manufacturing alone.

The impact of Scenario 2 or 3 across the more than 100 manufacturing sectors varies widely but the sectors in which a high proportion of output is sold in the EU market are the most vulnerable, e.g. automotive and pharmaceutical companies.

Investment decisions in the manufacturing sector are made over long periods, up to a decade. Many companies are delaying their decisions regarding new plants and production lines until there is more clarity, creating some inertia. There is a body of opinion that says that after Brexit, UK manufacturing will slowly wilt: research and development will gradually move away and future investment will be diverted as well. Some companies, like Unilever and Nestlé, have already made the decision to relocate jobs and production away from the UK to the Netherlands and Poland respectively.

One of the biggest concerns for industry is the impact of new trade barriers between the EU and the UK. There will be additional documentation required, delays due to customs checks and congestion at borders, all of which incur costs. The flow of goods in both directions will be slower impacting on time-sensitive industries. Congestion at the Port of Dover is a specific concern as the number of goods vehicles checked could increase more than 10-fold if all vehicles are subject to customs clearance.

The automotive industry Any change in tariffs and regulations will impact the UK automotive manufacturing industry and cause disruption across the extended supply chain. For example, the Mini’s headlights are made in Spain and are imported for assembly at the BMW facility in Oxford. The headlights are among the 60 per cent of the 3,000 components in a Mini that come from the European mainland. BMW has warned that delays could result in plant closures. Import tariffs alone could push up the list price of cars imported to the UK from the continent by an average of £1,500 if brands and their retail networks were unable to absorb these additional costs.

Last year, 54% of UK-built cars were shipped to customers in the EU. The SMMT reckons a no-deal shift to WTO tariffs would add £1.8bn to the cost of exports, forcing price increases. As one of the two biggest manufacturers in the UK, Nissan is concerned that its manufacturing costs will increase due to the disruption it is likely to experience in its just-in-time inventory (JIT) processes. Any customs checks could hold up parts shipments needed to keep its auto factories running smoothly. Whatever the Brexit outcome, sourcing of assembly parts and distribution of finished vehicles will be more costly, forcing organisations to rethink their medium to long-term investment strategies.

The pharmaceutical and life sciences industry The UK is currently a major player in the European drug approval process and has been the home of the European Medicines Agency (EMA). The EU is moving this regulatory agency for drugs to the Netherlands. It is expected that pharmaceutical companies will move manufacturing and drug testing facilities to within the EU to avoid tariffs and onerous regulations.

The UK Government has issued guidelines in the case of no-deal. These cover batch testing, ensuring the safe supply of blood and organs and the regulation of clinical trials and marketing approvals. The current uncertainty is a real problem for the pharmaceutical industry, where the development of drugs and other products depend heavily on the political and regulatory conditions of a country, and often require planning years in advance. It is expected that there will be slower authorisation of new medication and medical devices in future.

Continuity of supply is a real risk. Medicinal insulin, used by millions of diabetes patients is not manufactured in the UK, nor is it easily stored, as it requires temperature-controlled conditions. Disruption to the supply chain due to a no-deal Brexit would have severe consequences. .

What manufacturers really want is free trade, zero tariffs and frictionless trade across borders – an unlikely scenario. Those companies that have not developed contingency plans for the various scenarios may be disadvantaged.

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