ICH-GCP guidelines, MedDRA coding, causality assessment and signal detection compliance in pharmaceutical industry
Sub Category
- Science
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Objectives
- Master the complete pharmacovigilance reporting process from adverse event identification to regulatory submission
- Apply ICH-GCP guidelines and regulatory requirements for global pharmacovigilance compliance in pharmaceutical industry
- Conduct comprehensive causality assessment and signal detection for drug safety monitoring in clinical trials
- Create professional Individual Case Safety Reports using MedDRA coding and prepare expedited safety reports for regulatory authorities
Pre Requisites
- Basic understanding of medical terminology is helpful but not required. Open to healthcare professionals, pharmacy graduates, medical students, life science graduates, and anyone interested in building a career in drug safety and pharmacovigilance. No prior pharmacovigilance experience needed - this course will teach you everything from the ground up.
FAQ
- Q. How long do I have access to the course materials?
- A. You can view and review the lecture materials indefinitely, like an on-demand channel.
- Q. Can I take my courses with me wherever I go?
- A. Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don't have an internet connection, some instructors also let their students download course lectures. That's up to the instructor though, so make sure you get on their good side!
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