Day one- STREAM 1: RISK MANAGEMENT STRATEGIES

• › Sabine Richter, VP Safety and Risk Management, PRA International

• Effective risk management throughout the lifecycle of a drug
• When to start, and is there a true continuum?
• Risk management vs. risk minimization
• Relevant data sources and tools for effective risk management
• Resource and skill set requirements
• Implementation of risk minimization strategies
 

• › Mariette Boerstoel-Streefland, Chief Safety Officer, Vice President Global Drug Safety, Forest Research Institute, Forest Laboratories

• Relevant regulations and guidelines
• Challenges with clinical trial data
• Strategies and operational considerations
• Tools for signal detection and signal confirmation
 

• › Sabine Richter, VP Safety and Risk Management, PRA International

- Stakeholder engagement
- Effective communication with stakeholders
- Benefit risk tools
 

• › Dr. Reinerio Deza, Head Global Pharmacovigilance, Cubist Pharmaceuticals, Inc.

The EMA regulatory reporting requirements for marketed biopharmaceutical products have changed.  Periodic update reports that used to focus on case line listings, safety, and safety assessment now must also address periodic updates to product benefit, and include a formal assessment of benefit-risk.  Multi-Criteria Decision Analysis (MCDA) has been identified as a cornerstone of the methodology used for the quantitative modeling of a product’s benefit-risk profile.  The presentation will focus on the new content requirements, the implementation of MCDA modelling with marketed products, and the impact of the new regulations on content and membership of Safety and PV teams.

• › Jonathan Morris, Vice President, Evidence Development, UBC

• How do we best capture and characterize the benefit risk profile of a drug?
• What are they key obstacles to overcome?

• › Robin Geller, Director of Risk Management and Safety Writing Global Pharmacovigilance, Baxter Healthcare Corporation