In the past, complying with the expectations of risk management plans (RMPs) has been challenging on multiple levels. The overhauls to European Medicines Agency Module V and Module XVI this year will bring a tidal wave of complications to the work of professionals charged with developing, implementing and executing RMPs. Notably, the introduction of evidence-based standards for RMPs will upend your practice. You should prepare to target pharmacovigilance to specific drug groups and different segments of the population. Changes to Module V also include mandatory post-approval efficacy and follow-up surveys on the impact of communications and the incorporation of patient preferences into benefit-risk profiles.

With the introduction of RMP mandates across the globe with disparate timelines and requirements, the Risk Management Plan Summit is critical to the development and successful planning and execution of RMPs. Harmonisation is particularly essential to your success, your company’s success and the health outcomes of patients.

This two-day educational conference will showcase best practices and lessons learned in order to ensure delegates are informed, equipped and ready to replicate, implement, and execute and refine RMPs that comply with global mandates. By attending, you will learn from and interact with the foremost experts, risk management leaders, peers and the preeminent thinkers who comprise our esteemed speaking faculty.

Top Reasons to Attend

1. Get updates on regulations globally including EMA’s GVP Modules V and XVI
2. Incorporate an app/technological tool as a medium to monitor and track activities at the local level
3. Implement and harmonise on a global scale from a regional or centralised model with cross-functional teams
4. Tailor communications to the needs of specific patients with disparate backgrounds
5. Evaluate drug safety and patient outcomes and incorporate analysis into modifications

Who Should Attend

This conference is designed for professional from pharmaceutical and biotechnology companies with responsibilities in the following areas:

• Benefit/Risk Management
• Epidemiology/Pharmacoepidemiology
• Global/Regional Pharmacovigilance
• Biostatistics
• Medical Writing
• Risk Analysis/Assessment
• Global Drug/Product Safety
• Local/Regional Medical Safety
• Safety Evaluation/Reporting
• Medical Information
• Patient Safety
• Therapy Area Safety
• Integrated Medical Safety
• Safety Surveillance/Operations
• Clinical Data Management
• Clinical Risk Management
• Regulatory Affairs/Legal
• Compliance Management
• Patient Engagement
• Pre/Post Marketing
• Life Cycle Management