M1 Drug Safety Regulation and Good Pharmacovigilance Practices

Acquire a strong knowledge and a deep understanding of both local and global regulation and good pharmacovigilance practices which is the key to reach compliance and face challenges during audits and inspections.

This module is part of the learning path to be Qualified Professional in Pharmacovigilance and Drug Safety (QPDS)

What is Module 1?

As Drug safety is a highly regulated field, in this module, the pharmacovigilance trainee will acquire a strong knowledge and a deep understanding of both local and global regulation and good pharmacovigilance practices which are the key to reach compliance and face challenges during audits and inspections.

About Instructor

Dr. Omar Aimer

Has over 10 years of experience focusing on Quality Assurance and Risk Management of Medical Devices in the hospital environment and more than 8 years in Pharmacovigilance. He has a Master of Pharmacovigilance and Drug Safety from Paris Descartes University with a strong knowledge of the European Medicine Agency's Pharmacovigilance Regulation and Good Pharmacovigilance Practices, and 5 years of experience in Pharmacovigilance in France (ANSM and Hospitals). Omar has 11 years of experience as a lecturer on Pharmacology in Algiers (Algeria) and Clinical Research in Versailles (France) and Organized Pharmacovigilance workshops in Montreal Canada. Since 2017, he works as a Pharmacovigilance Specialist Pharmaceutical Industry in Canada. Omar is an author and international speaker about the impact of Artificial Intelligence on Pharmacovigilance. He is currently leading projects for pharmacovigilance training and mentoring students at McGill University. In 2020, Omar earned a Certification on Improving Global Health Focusing on Quality and Safety from Harvard University. He is also an active member of the International and North American Society of Pharmacovigilance.

5 Courses

Not Enrolled

Course Includes

  • 6 Lessons
  • 6 Quizzes
  • Course Certificate

Ratings and Reviews

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What's your experience? We'd love to know!
Arcelia Alvarez
Posted 2 months ago
Exceeded my expectations

The contents are clearly explained, accurate and well documented, this module brings together all the information needed to have a good knowledge of worldwide PV regulations, pointing out the key points and summarizing the most important data. It would have been better to get to know a bit more about clinical trials regulations, I think it was more focused on post-marketing.

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Saly Dahab
Posted 4 months ago
Highly Recommended

This course so clear and proficient, I am really enjoying this course. It added much to my knowledge and motivated me to start a new career in drug safety.

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Fatima Abdallah
Posted 7 months ago
Highly recommended

This course so clear and proficient, I am really enjoying every bit of it. I believe it is really adding up to my knowledge and increasing my desire to have a specialty in this field.

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Pinak Joshi
Posted 8 months ago
Helped Me Get My First Pharma PV Job!

If you are even remotely interested in PV, this is hands down the best course you can get. The course materials are up-to-date, and every lecture is extremely important from a working job perspective. The things Dr. Aimer teaches here are the fundamental building blocks to your first steps in a PV career. Using what he teaches, I was able to perform well during my interview selection in a pharma c

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Katayoun Sabet
Posted 8 months ago
Very Well Organized

This course is well organized and clear. Provides a great base to build on. Highly recommended to anyone who is interested in PV.

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