#afsaneh motamed khorasani

[easyglobaltraining]

ASSESSING REGISTRIES TO SUPPORT DRUG REGULATORY DECISION-MAKING

The Cures Act of the 21st Century, enacted on December 13, 2016, aimed to expedite the development of medical products and facilitate quicker and more efficient delivery of innovations and advancements to patients in need. One of its additions was section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act). In compliance with the stipulations in section 505F, the FDA established a framework for the Real-World Evidence (RWE) Program, which assesses the potential utilization of RWE to aid in the approval of a new indication for a drug previously sanctioned under section 505(c) of the FD&C Act.

Read more at : https://lnkd.in/g4bgzuEK

#easy global training #FDA #afsaneh motamed khorasani #Regulatory training

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Webinar from Traininng.com about Good Documentation and Record Keeping Best Practices (FDA & EMA) on January 24

Webinar from Traininng.com about Good Documentation and Record Keeping Best Practices (FDA & EMA) on January 24

Fremont, CA: Traininng.com, a reputable provider of training courses for professionals for all the areas of regulatory compliance, is organizing a webinar on the topic, “Good Documentation and Record Keeping Best Practices (FDA & EMA)” on January 24, 2019. The speaker at this webinar is Afsaneh Motamed Khorasani, a Medical and scientific Affairs expert and a Senior Scientist. Please visit to…

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#difference between documentation and record keeping #FDA #GDP Enforcement #good documentation best practices #online professional trainings #regulatory training #Rules and Principles of GDP

[easyglobaltraining]

Unlock Your Potential with EASY Global Training

A short introduction to Easy Global Training and its products & services, presented by its president and CEO, Dr. Afsaneh Motamed Khorasani.

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Good Documentation & Record Keeping Best Practices (Drugs & Devices)

Good Documentation & Record Keeping Best Practices (Drugs & Devices)

Speaker’s Bio: Dr. Afsaneh Motamed Khorasani is a Medical and scientific Affairs expert and a Senior Scientist. Moreover, she has a strong background in biomedical science and clinical trial/research. Also, she has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and development, clinical trials, Medical and regulatory writing, and intellectual…

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[easyglobaltraining]

How to prepare a winning Standard Operating Procedure (SOP)

How to prepare a winning Standard Operating Procedure (SOP)

Speaker Bio:   Dr. Afsaneh Motamed Khorasani is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical science and clinical trial/research. She has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and development, clinical trials, Medical and regulatory writing and intellectual property. She is…

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Good Documentation Practices (Laboratory Notebooks & non-clinical laboratory studies (21 CFR Part 58))

Good Documentation Practices (Laboratory Notebooks & non-clinical laboratory studies (21 CFR Part 58))

Speaker Bio: Dr. Afsaneh Motamed Khorasani is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical science and clinical trial/research. She has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and development, clinical trials, Medical and regulatory writing, and intellectual property. She is…

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[easyglobaltraining]

What are the steps of New Drug Development (NDA)?

Read more on the steps of new drug development ...

In this article, we try to expand on “steps of New Drug Development” in general to give you an idea of the steps involved in this process and the importance of it. In France, six out of 90 volunteers to try a new drug went to the hospital after undergoing clinical trials, and three of them died of brain death. Naturally, the clinical trial of the drug has now stopped and the drug company has…

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#regulatory #quality #ebola #easy global training #afsaneh motamed khorasani #regulatory consulting #quality consulting #medical affairs consulting #GMP

[easyglobaltraining]

Wearable brain-computer interface (BCI) Systems and their Advances

Read more on wearable brain-computer interface systems

In this post, we would like to discuss brain-computer interface (BCI), what it is and the new advances in this field. There has been a rapid growth of studies in the field of brain-computer interface in the last decade. A brain-computer interface often includes: A set of sensors to acquire neurophysiological intention signals A wired or wireless system to transmit this data A processing…

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#regulatory #quality #afsaneh motamed khorasani #regulatory consulting #quality consulting #GMP #medical affrais #medical affairs #easy global trianing

[easyglobaltraining]

What We’ve Learned from the Epidemiology of Ebola

Read more on what we have learned from epidemiology of Ebola ...

Dr. Afsaneh Motamed Khorasani has drafted a summary of what we have learned from the epidemiology of Ebola so far. Bottom line, with all the progress and new findings and observations in the field of health sciences, it is on every one of us to educate and update ourselves and ask the right questions. Please feel free to read the one page summary at your own…

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