Training Course on Benefit/Risk Management

Venue: Courtyard Marriott City Centre

Location: Munich, Germany

Event Date/Time: May 24, 2012 End Date/Time: May 25, 2012
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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

What You Will Learn Study designs for safety and efficacy follow-up and how to measure their effectiveness
Taking advantage of new legal possibilities for benefit optimization and risk minimization of your products in the EU
Training for situations when benefit-risk of your product is at stake and you need to manage a media, legal, and regulatory crisis
Comprehensive and practical training in designing benefit/risk management systems using regulatory tools such as EU-RMP, Risk Evaluation and Mitigation Strategies (REMS), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), Follow-Up Measures (FUMs), and possibly the EU Benefit Risk Management Plan (EU-BRMP)

Who Should Attend Professionals with two to five years of experience in regulatory affairs, risk management, pharmacovigilance, drug safety, medical affairs, or similar positions within the pharmaceutical industry
Professionals charged with the design and maintenance of risk management systems, QPPVs and heads of benefit/risk management, patient safety, or lifecycle management

Participants who complete this course should be able to:

Describe safety, efficacy, and effectiveness profiles of drugs
Plan safety and efficacy follow-up systems, including the best choice of study designs and available registries
Optimize benefits and minimise risks of products, including the best use of an evidence-based toolbox
Present the first three bullet points to key regulatory authorities and health technology assessment bodies
Measure effectiveness of the planned actions—both risk minimisation and benefit optimization
Save the product if things go wrong and benefit-risk seems negative

Event Code:12561