-
Pharmacovigilance Inspection
-
This 2 day intensive seminar will equip you with a comprehensive overview of safety management strategy and tools:
- Understand the pharmacovigilance regulatory system and recent regulatory measures in drug safety management in China
- Compare the requirements of ADR reporting and Risk plan reporting for drug registration in China and overseas markets
- Recognize the basic concepts of data mining and principles of signal detection together with applications of data mining technology
- Compare and contrast US and EMEA inspectional approaches in clinical safety and post marketing pharmacovigilance
- Explain how companies can be prepared for safety-related regulatory inspections
- Familiarize yourself with ICH “Pharmacovigilance Planning” E2E Guidelines, FDA’s “Development and Use of Risk Minimization Action Plans” guidance, EMEA’s “Guideline on Risk Management Systems for Medicinal Products for Human Use” and FDAAA-mandated Risk Evaluation and Mitigation Strategies (REMS)
- Be aware of the relationship between pharmacovigilance planning and post-marketing risk management
- Recognize the strengths and limitations of different methods of risk minimization
- Update your knowledge structure with latest best practices in advanced strategy and practice
Hear from Eminent Speakers like:
Stephen A. Goldman, MD, FAPM, DFAPA
Managing Member, STEPHEN A. GOLDMAN
CONSULTING SERVICES, LLC,
Former Medical Director, MEDWATCH, FDA, US
Wenmin Du, MD, PhD
Executive Director, Shanghai Center for Adverse
Drug Reaction Monitoring, SFDA, CHINA
Chen Yang
Partner, Head of China Life Sciences Practice,
SIDLEY AUSTIN LLP, CHINA
