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The course will be delivered by experienced trainers in the field who know the most critical aspects affecting PV employees firsthand. Throughout the training sessions, practical examples and frequently asked questions will be addressed through a rigorous and practical approach, our course will treat another different subject such as the international context of pharmacovigilance, and sources of information in pharmacovigilance, in order to document signal detection, ICSRs, PSURs, Referrals and more, presenting practical situations which may impact on daily activities.
We will also be talking about the latest updates national and international guidance (FDA, EMA,…) for signal detection in pharmacovigilance, with practical examples of medical evaluation in signal management, focussing also on the issues most frequently encountered.
Why Drug Safety and Pharmacovigilance?
Increasing demand across the world for skilled professionals who can carry out surveillance safety trials and make reliable reports by leveraging the technological advancements in the field.
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 is the key to reach compliance and face challenges during audits and inspections.
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Are You Ready To Start?
- PV and Drug Safety introduction 01:30:00
- Understand Regulatory Authorities’ Mandatory Requirements 01:30:00
- Post Marketing and Clinical trial PV 01:30:00
- Overview of case processing 01:30:00
- Summary Reports 01:30:00
- Pharmacovigilance Drug Safety within Product Lifecycle (Drug Development, Marketing authorization, PV terminology) 01:30:00
- International Regulation WHO (UMC), ICH, CIOMS 01:30:00
- European Regulation (EMA, Good Pharmacovigilance Practices, Eudravigilance) UK Regulation and Brexit 01:30:00
- US Regulation (FDA, FAERS, MedWatch, HIPAA) 01:30:00
- Canadian Regulation (Health Canada Canadavigilance, Good Pharmacovigilance) 01:30:00
- Other regulations (Japan, China, MENA) 01:30:00
- Pharmacovigilance System 01:30:00
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