Training Course on Benefit/Risk Management

This intensive course explores current opportunities in the pharmaceutical industry made possible by new legislation, advances in information technology, and a new scientific methodology to enhance and modernize approaches in product lifecycle management.
The course covers:

• Current regulatory thinking about the benefit-risk methodology, including the relevant project of the European Medicines Agency (EMA)/Committee for Medicinal Products (CHMP) for Human Use
• The new European benefit/risk management planning—a notion stemming from experience gathered over five years with the EU Risk Management Plans (EU-RMPs)
• How to take advantage of the efficacy follow-up options given by both the European Paediatric Regulation and Advanced Therapies Regulation
• Drafting key aspects of the regulatory submissions
• Dealing with the most dangerous unforeseen scenarios—when the benefit-risk of the product is suddenly affected by emerging information—and using risk communication and media crisis management techniques

Event Code:12561

Jan Petracek, MD,MSc

CEO, Director of Pharmacovigilance Services
European Pharminvent Services, s.r.o., Czech Republic

Jan-Willem Van der Velden, DrMed

CEO
Mesama Consulting, Switzerland