Drug Safety Summit Description Image

Furthering Drug Safety Operations Through Industry Education

The Fierce Drug Safety Summit brings thought leaders from across pharma, biotech, and device companies to explore current challenges faced when ensuring the safety of patients. Leaders in pharmacovigilance, drug safety, risk management, and regulatory affairs will discuss the most effective ways to institute a risk management program and be better equipped to meet government regulations.

Optimize your Drug Safety Operations by Attending Sessions from our Two Tracks

Risk Management & REMS

FDA Updates
Risk Management Plan Development
Vendor Engagement
Regional Differences


Global PV
FDA Guidance
Technological Advancements
Inspection Readiness

Don't Miss These Featured Sessions with our FDA Speakers

FDA Opening Presentation: Current State of REMS Initiatives

  • Learn about the new REMS Document Technical Conformance Guide 
  • Hear about the latest updates to the REMS Integration project 

Completing the Risk Management Cycle: Risk Management Effectiveness Across US and EU

  • Review effectiveness of measure requirements for additional risk minimization measure (aRMMs) in EU and REMS in US
  • Describe the current landscape of methodologies that measure effectiveness and identify the best approach that overcomes challenges currently seen
  • Discuss future changes that may result from the FDA’s initiative to Modernize and Improve REMS Assessments
FDA Speaker Headshots

Featured Sessions:

  • Panel: Strategic and Innovative Approaches to Designing and Executing Post-Approval Safety Studies
  • Best Practices to Consider when Conducting Post-Market Studies and REMS Activities in Combination Products
  • Navigate the Challenges within PV Agreement Development and Implementation to Comply with PV Regulations
  • Understand the Differences between U.S., E.U., and Japan Safety Regulations to Avoid Pitfalls in Global Safety Operations
  • Panel: Successfully Harmonize Operations to Meet Global Pharmacovigilance Requirements 
  • Panel: Successfully Collaborate with Vendors in the Early Stages of REMS Development to Limit Setbacks and Streamline Processes 

Top Reasons to Attend

  1. Breakdown the key differences between the U.S. and other regions' regulation structures and the impact they have on operations 
  2. Learn best practices for being inspection ready across your drug safety teams 
  3. Understand how to successfully mitigate challenges caused by data silos and data gaps when compiling and analyzing reports for specific disease states.  
  4. How to better connect with patients to ensure the safety plan fully encompasses the needs of a targeted patient group.   
  5. Gain perspectives on successfully working across functions to ensure your team meets compliance standards.   


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According to previous attendees, the greatest benefit of attending was…

  • Understanding current challenges/solutions in drug safety.
  • Connect with drug safety experts and discuss details on FDA guidelines and other drug safety requirements.
  • Seeing different perspectives from pharmaceuticals, vendors, regulatory, and patients.
  • The connection to others that are also in the niche world of REMS.
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