globalinstituteregulatoryaffairs

[globalinstituteregulatoryaffairs]

The pharmaceutical and healthcare sector has grown tremendously in the past few years. Out of which, pharmacovigilance is coming out as a viable option for students to build a stable career. The career growth and opportunities in Pharmacovigilance are immense. Pharmacovigilance aims to gather, understand, assess, and prevent adverse effects of a drug or medicinal product. This is done by various processes such as

1. Individual Case Safety Reports (ICSR).

2. Clinical Review of Safety Reports.

3. Cohort Event Monitoring.

4. Longitudinal Electronic Patient Reports.

5. Periodic Safety Update Reports (PSUR).

6. Spontaneous Recording.

7. Record Linkage.

8. Expedited Report.

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[globalinstituteregulatoryaffairs]

Certification Program in Drug Regulatory Affairs:Join the course and Become a Drug Regulatory Affairs Expert,This program helps to provide comprehensive education on the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry.

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Who Can attend this course:

-Pharmaceutical industry employees

-Pharmacy Students & Pharma Professionals

-Chemistry students

-Science Graduates

-Diploma in pharmacy

-Pharma professionals

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Study Material will be provided to the students. We provide 100%

Placement Assistance,

Admissions Open!!!!

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Call/Whatsapp For Enquiry:

Call:[phone] , Email:[email protected]

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[globalinstituteregulatoryaffairs]

A skilled engineer, regardless of the position title, remains a treasure. Let's praise engineers for their dedication and sacrifices, without which the world would not have reached this pinnacle of industry and civilization.

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eCTD Submission Certification Program - Part Time/Distance Learning,Enroll now for the “Certificate Course in eCTD Submissions” andGet Live training on eCTD software!!!

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The eCTD specification has been developed to facilitate the Global electronic Submission, Review, and Lifecycle management of medicinal product dossiers for regulatory applications.

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Who Should Attend???

QC/QA Managers & Staff

-Documentation Department

-Regulatory Affairs Department - Responsible for CTD /DMF Preparation & Submission

-Research Chemist, Quality Control Chemist, CRO's involved in Documentation

-pharmacy Graduates with knowledge of CTD

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Course Offered:

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[globalinstituteregulatoryaffairs]

Computer System Validation Certification Course:Pharmaceutical and Medical Device manufacturing industries are highly regulated environments that directly impact public health & safety, hence the CSV process is imperative here.

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Who Should Apply:

-Quality assurance and quality control specialists,

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-Technical support personnel, engineers, and all levels of management need a fundamental understanding of computerized system compliance and regulations.

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Course Offered:

LIVE TRAINING SESSION,

E-LEARNING,

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Study Material will be provided to the students.We provide 100% Placement Assistance,For Enquiry Email at [email protected] Open!!!!

CALL/WHATSAPP For Enquiry:[phone]

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[globalinstituteregulatoryaffairs]

Department of Regulatory Affairs is a crucial part of any pharmaceutical, biopharmaceutical, medical device, nutraceuticals, veterinary, and cosmetic industry. The department is focused on maintaining the quality standards and safety of medicinal products in different markets around the world. To make this possible, the regulatory professionals keep a close eye on all the products on various parameters such as development, manufacturing, testing, and distribution. This department also works closely with the government authorities to regulate the activities of the company. A career in regulatory affairs offers immense opportunities and growth for students keen to learn and acquire knowledge.

Skills Required for Regulatory Affairs

The rules and regulations around the world are different for every region around the world. These rules are much more stringent for pharmaceutical and medicinal products owing to the safety of the public. Hence, regulatory professional has to be on their toes at all times and keep themselves updated with the new norms and legislations.

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[globalinstituteregulatoryaffairs]

HOW TO GET A JOB IN REGULATORY AFFAIRS?

Department of Regulatory Affairs is a crucial part of any pharmaceutical, biopharmaceutical, medical device, nutraceuticals, veterinary, and cosmetic industry. The department is focused on maintaining the quality standards and safety of medicinal products in different markets around the world. To make this possible, the regulatory professionals keep a close eye on all the products on various parameters such as development, manufacturing, testing, and distribution. This department also works closely with the government authorities to regulate the activities of the company. A career in regulatory affairs offers immense opportunities and growth for students keen to learn and acquire knowledge.

Skills Required for Regulatory Affairs

The rules and regulations around the world are different for every region around the world. These rules are much more stringent for pharmaceutical and medicinal products owing to the safety of the public. Hence, regulatory professional has to be on their toes at all times and keep themselves updated with the new norms and legislations.

A career in regulatory affairs is demanding and it asks for a particular set of skills to excel in the domain, such as:

1. Attention to Detail:

Documentation is an integral part of a regulatory affair job role. This documentation consists of hundreds of pages with pharmaceutical protocols, legislation, business, and so forth. A lot of times the professionals are also required to draft and review such documents within stringent timelines. This calls for a brilliant eye for detail.

2. Diverse Knowledge:

The department of regulatory affairs offers a diverse horizon for candidates in science, law, and business. The professionals working in the department should be well aware of the drug development process right from its inception to its marketing. At the same time, the professionals should also know the legal aspects of the drug in different parts of the world.

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Regulatory Affairs Courses

3. Writing Skills:

As mentioned above, regulatory professionals are required to draft critical documents. The professionals also have to review hundreds of pages about the quality, safety, and efficacy of a medicinal product. This asks for a flair for writing.

4. Organizational Skills:

Regulatory affairs involve a variety of tasks such as coordinating application procedures for a medicinal product drafting an application and so forth. Sometimes the regulatory specialist has to coordinate with different departments to ensure the adherence to legalities. All of this calls for exceptional organizational skills.

Education Required for Regulatory Affairs

To become a regulatory affairs specialist, you will need a bachelor’s degree in life science specifically in pharmacy, pharmacology, and biochemistry. A graduation or post-graduation degree is sufficient for a junior position. The senior-level, however, demands a doctorate

Concepts Which One Should Know to Get a Job in Regulatory Affairs

To become a successful regulatory specialist, you should know the following:

1. Investigational New Drug Application (IND)

An investigational new drug application or IND refers to an application that is filed with the United States Food and Drug Administration (USFDA) to get legal approval for testing an experimental drug on humans.

2. New Drug Application (NDA)

A new drug application or NDA is a key application that is filed with the USFDA to approve a new pharmaceutical product for sale and marketing in the United States. Data from the animal and human studies gathered from an IND is collated to submit an NDA.

3. Abbreviated New Drug Application (ANDA)

An abbreviated new drug application or ANDA refers to an application that is filed with the USFDA to approve the sale and marketing of a generic drug product in the United States.

4. Generic Drug Product

A generic drug product is comparable to an innovator drug product in terms of its strength, route of administration, quality, performance characteristics and intended use

5. Orange Book

Orange Book is an electronically available free database which contains a list of drugs approved as both safe and effective by the USFDA.

6. Drug Master File or DMF

A drug master file or DMF refers to submission to the USFDA. It provides confidential and thorough information about the medicinal product concerning manufacturing facilities, process, packaging, and storage of drugs. This application is submitted to the USFDA as absolute confidential information about the product.

7. 505 (b)(2) Application

A 505 (b)(2) application is also a type of NDA for which the investigations rely on the applicant. The investigation for these is carried out by the applicant but the right to approval does not lie with the applicant.

8. Common Technical Document (CTD)

A common technical document or CTD refers to an application dossier that is prepared for the registration of drug products in Europe, Japan, and the United States. The document includes detailed information about the quality, safety, and effectiveness of the drug product.

9. Marketing Authorization Application (MAA)

A marketing authorization application or MAA refers to an application filed with the relevant authority in Europe for marketing a drug product.

To Sum It Up

Regulatory affair is an interesting career option for students with zeal to learn and grow. This diverse field will give you insight into a medicinal product right from its development to marketing. If you wish to build a career in the domain, contact us here. If you want to learn more and get in-depth knowledge, try our drug regulatory affairs course.

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[globalinstituteregulatoryaffairs]

Department of Regulatory Affairs is a crucial part of any pharmaceutical, biopharmaceutical, medical device, nutraceuticals, veterinary, and cosmetic industry. The department is focused on maintaining the quality standards and safety of medicinal products in different markets around the world. To make this possible, the regulatory professionals keep a close eye on all the products on various parameters such as development, manufacturing, testing, and distribution. This department also works closely with the government authorities to regulate the activities of the company. A career in regulatory affairs offers immense opportunities and growth for students keen to learn and acquire knowledge.

Skills Required for Regulatory Affairs

The rules and regulations around the world are different for every region around the world. These rules are much more stringent for pharmaceutical and medicinal products owing to the safety of the public. Hence, regulatory professional has to be on their toes at all times and keep themselves updated with the new norms and legislations.

#RegulatoryAffairs #JobsRegulatoryAffairs #RegulatoryAffairsCourses #drugregulatoryaffairscourse #medicaldeviceindustry

[globalinstituteregulatoryaffairs]

The pharmaceutical and healthcare sector has grown tremendously in the past few years. Out of which, pharmacovigilance is coming out as a viable option for students to build a stable career. The career growth and opportunities in Pharmacovigilance are immense. Pharmacovigilance aims to gather, understand, assess, and prevent adverse effects of a drug or medicinal product. This is done by various processes such as

1. Individual Case Safety Reports (ICSR).

2. Clinical Review of Safety Reports.

3. Cohort Event Monitoring.

4. Longitudinal Electronic Patient Reports.

5. Periodic Safety Update Reports (PSUR).

6. Spontaneous Recording.

7. Record Linkage.

8. Expedited Report.

#PharmaceuticalIndustry #healthcaresector #Pharmacovigilance #Pharmacovigilancecourse #PharmacovigilanceCourseinindia #pharmacovigilancejobs

[globalinstituteregulatoryaffairs]

Pharmacovigilance Job Opportunities In Top Companies

The pharmaceutical and healthcare sector has grown tremendously in the past few years. Out of which, pharmacovigilance is coming out as a viable option for students to build a stable career. The career growth and opportunities in Pharmacovigilance are immense. Pharmacovigilance aims to gather, understand, assess, and prevent adverse effects of a drug or medicinal product. This is done by various processes such as

1. Individual Case Safety Reports (ICSR).

2. Clinical Review of Safety Reports.

3. Cohort Event Monitoring.

4. Longitudinal Electronic Patient Reports.

5. Periodic Safety Update Reports (PSUR).

6. Spontaneous Recording.

7. Record Linkage.

8. Expedited Report.

A candidate in pharmacovigilance performs the following functions:

1. Reporting adverse events received from customers or healthcare bodies.

2. Reducing the risk of serious side effects.

3. Creating and reviewing serious adverse effects reports.

4. Performing safety audits.

Types of Companies Hiring in Pharmacovigilance

Pharmacovigilance provides a bright career option in terms of both growth and salary. The starting position in the domain is a pharmacovigilance associate or drug safety associate. The companies that hire pharmacovigilance professionals are:

1. Pharmaceutical companies.

2. Contract research organizations.

3. Biotechnology companies.

4. Dedicated pharmacovigilance centers.

5. Regulatory authorities.

6. Knowledge process outsourcing companies.

The above companies offer pharmacovigilance jobs for the following profiles:

1. Drug safety associate.

2. Pharmacovigilance associate.

3. Case processing expert.

4. Safety associate.

5. Clinical safety scientist.

6. Pharmacovigilance scientist.

Top 20 Pharmacovigilance Companies in India

1. Novartis

Novartis is headquartered in Basel, Switzerland and based out of Hyderabad in India. The company is also a CRO for pharmacovigilance and clinical data management.

2. Parexel

Parexel is one of the oldest and most popular CROs based out of Hyderabad in India. The company also operates in Chandigarh and Bangalore. It provides jobs in pharmacovigilance, regulatory affairs, clinical data management, medical writing, and so on.

Talk to us now for best suited

Pharmacovigilance course

3. Syneos Health

The INC Research and inVentiv Health merged to form a new company called Syneos Health. It is a well-known company from the US which is based out of Hyderabad, Pune and Delhi in India. It provides job opportunities in pharmacovigilance, clinical data management, medical writing, and so on.

4. Cognizant

Cognizant is headquartered in the US and is based out of Hyderabad, Mumbai, Pune, and Kolkata in India. It offers services in pharmacovigilance and clinical data management. Cognizant has numerous job opportunities for pharmacy graduates and postgraduates. Cognizant is one of the world's leading professional services firms, transforming clients' business, operating, and technology models for the digital world.

5. Accenture

Accenture is headquartered in Dublin, Ireland and based out of Bangalore, Chennai, and Hyderabad in India. It is the first big IT company to introduce pharmacovigilance services in India

6. Tata Consultancy Services (TCS)

TCS is a multinational company headquartered in Mumbai, India. It also operates in Pune, Nagpur, Indore, and Hyderabad. The company hires professionals for pharmacovigilance, clinical data management and regulatory affairs. TCS is increasing its Research and Development team for the Pharma Division and they are actively recruiting Pharmacovigilance Associates and Clinical Researchers.

7. Vigimedsafe

Vigimedsafe is headquartered in the US and based out of Hyderabad in India. It provides services in pharmacovigilance under various brackets such as aggregate reporting, signal detection, narrative writing, and so on. It is also a great company for freshers to learn and excel in the domain.

8. Makrocare

Makrocare is another old CRO based out of Hyderabad in India. The company offers opportunities in pharmacovigilance, clinical research, medical writing, regulatory affairs, and clinical data management.

9. Indegene

Indegene is a CRO headquartered in Bangalore, India. The company also finds its presence in the US, UK, China, and Japan. It offers job opportunities in pharmacovigilance, clinical data management, medical writing, and so on.

10. Freyr Solutions

Freyr Solutions is a leading company based out of Hyderabad in India. It provides end-to-end services in pharmacovigilance, regulatory affairs, and clinical data management.

11. iSafety

iSafety is another leading life science organization which provides opportunities in pharmacovigilance and clinical data management.

Apart from the above, the other companies hiring for pharmacovigilance are:

12. Dr Reddy’s Laboratories.

13. Aurobindo Pharma Limited.

14. BioClinica.

15. Inventive.

16. Genpact.

17. Quintiles.

18. HCL.

19. Novo Nordisk.

20. Kinapse.

21. Syngene.

Pharmacovigilance Job Locations in India

Pharmacovigilance services are provided by huge multinational giants based out of India with their services functional in the country. These companies have a global foothold in the pharmacovigilance domain and are based in metro cities in India. If you are interested in building a career in pharmacovigilance, you might have to consider moving to the following cities

1. Hyderabad.

2. Bangalore.

3. Mumbai

4. Pune

5. Chandigarh

6. Delhi

7. Chennai

To Sum It Up

Pharmacovigilance is a promising career for healthcare students. It offers a great salary along with stable career growth. The companies providing pharmacovigilance services are prominent all over the world with their headquarters in the US or Europe. In India, these companies are based out of metro and Tier-1 cities such as Bangalore, Hyderabad, Mumbai, and so on. If you wish to build a stable career in pharmacovigilance. For more information and to get trained click on Pharmacovigilance Course

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Are you a Life Science/Pharmacy Graduate student dreaming of making a career in regulatory affairs? Medical Device RA/Pharmacovigilance is a great career option to start... . . We Provide Regulatory Training Courses For -Medical Device RA -QA/QC Program -Biotech Regulatory -Validation Training -Food Regulatory -DRA-Distance Learning -ECTD-Training -Pharmacovigilance Course . . We provide 100% Placement Assistance, Course Offered: LIVE TRAINING SESSION, E-LEARNING, . . Excellent Opportunity for Pharma and Graduates All final year students of any stream of life sciences, . . Hurry Up, Admissions Open!!!! Register now at GIRA to become an expert in regulatory affairs CALL/WHATSAPP For Enquiry: [phone] More info visit:http://bit.ly/3sZQbEc

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Do you want to Learn about EU MDR (European Medical Device Regulation)? We Provide training courses on (EU-MDR/2017/745 & CE marking) with recorded lectures, . . This course will help you to understand: The MDR’s additional requirements The current directives – MDD 93/42/EE and ISO 13485:2016 Terminology and certification requirements . . WHO SHOULD ATTEND? Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel. . . Hurry Up, Register now at GIRA, CALL/WHATSAPP For Enquiry: [phone] More info visit:http://bit.ly/3sZQbEc

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Confused to take a step ahead in your Career! We make it better for you, Make your career in the pharmaceutical industry. . . We provide certification courses in Drug Regulatory Affairs, Join the course and Become a Drug Regulatory Affairs Expert, . . Who Can attend this course: -Pharmaceutical industry employees -Pharmacy Students & Pharma Professionals -Chemistry students -Science Graduates -Diploma in pharmacy -Pharma professionals . . Register and start learning now. Admissions Open!! More info visit:https://bit.ly/3uiPCWK CALL/WHATSAPP For Enquiry: [phone] For Enquiry Email at [email protected]

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Certification Program in Quality Assurance and Quality Control(QA and QC): The Certification program is designed to benefit such candidates, specifically those who want to take advantage of working in the valuable and important quality assurance and quality control division of the healthcare industry. . . The Quality Assurance & Quality Control certification course teaches students how to establish, monitor, and oversee quality assurance and quality control procedures for manufacturing and testing procedures. . . . Course Features: 1. Study Materials & E-Learning Materials 2. Experienced and Quality Faculty 3.100 % Placement Assistance & Career Guidance . . For more info visit:https://bit.ly/3xs3hx1 CALL/WHATSAPP For Enquiry: [phone]

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[globalinstituteregulatoryaffairs]

Are you confused about your career After Graduation? Make your career in the pharmaceutical industry. We provide certification courses in Pharmacovigilance, Join the course and Become a Pharmacovigilance Expert. . . Excellent Opportunity for Pharma and Graduates All final year students of any stream of life sciences, Course Features: 1. Study Materials & E-Learning Materials 2. Experienced and Quality Faculty 3.100 % Placement Assistance & Career Guidance Hurry Up!!! Admissions Open!!!! Register now, CALL/WHATSAPP For Enquiry: [phone] More info visit:https://bit.ly/3xvcJ2y

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[globalinstituteregulatoryaffairs]

The medical device industries work in tandem with the pharmaceutical industries by providing innovative solutions to improve patient outcomes. The companies either innovate by updating the existing technology or developing a new device. These devices provide a means for the effective treatment of a particular disease or condition. A regulatory affairs professional performs a critical role in the medical device lifecycle-right from the innovation of the device to the device reaching the physician. It includes medical device compliance training, leading premarket strategy, drafting regulatory submissions, and ensuring post-marketing compliance. As all of these activities are scrutinized, it demands a professional with a specific set of skills.

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[globalinstituteregulatoryaffairs]

The Indian Pharma Industry has been growing at a rapid space in the last 4 -5 years, according to a McKinsey Report India Pharma 2015 the industry is expected to grow at a CAGR of 16% for the period of 2007-2011.

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