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.

Hear from Susan Welsh, MD, Senior VP, Pharmacovigilance and Chief Safety Officer at Mirati Therapeutics on Why this is a Must-Attend Event for Drug Safety Professionals

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.   

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

Risk Management & REMS

Major Themes


FDA Updates

Risk Management Plan Development

Vendor Engagement

Regional Differences



Major Themes


Global PV

FDA Guidance

Technological Advancements

Inspection Readiness


Featured Sessions:

  • Keynote Panel: How to be Inspection Ready Across PV Risk Management Systems
  • Understand the Evolving Role Epidemiology has within Drug Safety
  • Setting the Right Expectations for the Resources and Workload Involved in Developing a REMS Program
  • Complete the Risk Management Cycle: Review of Risk Management Effectiveness Across US and EU
  • Panel: How Teams can Use Data to Ultimately Improve the Quality of Information used within Safety Assessments
  • Developing Definitions for Safety Topics of Interest for Newer Therapies


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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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