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)
M0 Pharmacovigilance Introduction and Basics
M1 Drug Safety Regulation and Good Pharmacovigilance Practices
M2 Pharmacovigilance and Drug Safety Operations
M3 Safety Medical Writing, Quality and Compliance
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.
Course Content
About Instructor
Course Includes
- 6 Lessons
- 6 Quizzes
- Course Certificate
Ratings and Reviews
Arcelia AlvarezThe 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.
Pinak JoshiIf 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
very informative.