12th Risk Evaluation and Mitigation Strategies Summit (REMS)

Key Topics

• A thorough assessment of the European guidance Module 16
• The FDAs newly released REMS Standardization Report
• Case studies on best practices, lessons learned, and successful strategies and tools for REMS design , development and modification by a cross section of small to large companies
• How to overcome challenges in a single shared REMS from experienced professionals
• How REMS is managed by hospitals and pharmacy organizations

Who should Attend

Attendees involved or interested in

• Risk Management
• REMS
• Epidemiology/Pharmacoepidemiology
• Pharmacovigilance/Surveillance
• Quality Assurance
• Pharmacoeconomics
• Clinical Risk Management
• Drug/Product Safety
• Regulatory Affairs
• Lifecycle Management
• Clinical Data Management
• Clinical Affairs
• Clinical Risk Management Compliance
• Clinical Operations
• Marketing
• Medical Writing/Communications

and also attendees from:

• Contract Research Organizations
• REMS/Drug Safety Service Providers
• Technology Vendors
• Data Management Services
• Drug Safety & Risk Management Services
• Pharmaceutical Consultants
• Health Services Research and Academics
• Health Care Regulators and Policy Makers
• Speaker Bureaus
• Lifecycle Management Services