Risk Management Plan Summit – Risk Management Plan Summit

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 RMP Summit is critical to your 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 foremost experts, risk management leaders, peers and the preeminent thinkers who comprise our esteemed speaking faculty.

Top Reasons to Attend

  1. Comply with Modules V and XVI through cross-functional teams
  2. Ensure compliance and safe medication use through evidence-based RMPs
  3. Harmonise on a global scale from a regional or centralised model
  4. Maximise and measure the impact of communications with proven methods and sound metrics
  5. Account for benefit risk profiles in RMP and adjust accordingly to any changes in that profile
  6. Implement RMPs using principles of implementation science

Who Should Attend

This conference is designed for professionals from branded and generic pharmaceutical companies with responsibilities in the following areas:

  • Risk Management
  • Safety Evaluation/Reporting
  • Global Drug/Product Safety
  • Global Pharmacovigilance/Surveillance
  • Risk Analysis/Assessment
  • Medical Safety/Information
  • Benefit/Risk Management
  • Epidemiology/Pharmacoepidemiology
  • Clinical Risk Management/Pharmacology
  • Life Cycle Management
  • Regulatory Affairs/Legal/Compliance
  • Clinical Affairs
  • Clinical Data Management
  • Clinical Operations
  • Clinical Risk Management Compliance
  • Drug Disposition
  • RMP Sourcing/Implementation

This conference is also of interest to:

  • Risk Safety and RMP Service Providers
  • Data Management Companies
  • Consultancies
  • Dashboard and Metrics Service Providers
  • Law Firms