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Reflections from the 2nd American Drug Safety Summit

Pharma·Jacqueline Gerena·Oct 21, 2025· 2 minutes

On October 16, I had the privilege of both presenting and participating in a panel at the Why Summits — 2nd American Drug Safety Summit in Boston.

During our panel discussion, “REMS at a Crossroad: From Transition to Transformation,” we explored how the field of Risk Evaluation and Mitigation Strategies is evolving — and what’s needed to align safety innovation with real-world patient outcomes.

In my solo presentation, “Beyond the Box Warning: Inclusive Leadership Driving the Next Era of Safety Risk Management,” I shared how:

  • Inclusive leadership is reshaping REMS and safety risk management

  • FDA and ICH updates are driving equity in safety strategies

  • We can balance compliance, innovation, and patient access in practical, impactful ways

This talk was deeply meaningful to me — I built it the day before the conference to integrate my passion for equity and inclusion with my years of professional experience in risk management. The engagement, dialogue, and energy from the audience reaffirmed how vital this conversation is for the future of drug safety.

I’m grateful to have shared the stage with brilliant peers and to continue championing inclusive approaches that make healthcare safer and more equitable for all.

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Why Summit-ADSS_Workshop 1

#DrugSafety #REMS #Leadership #HealthEquity #InclusiveLeadership #RiskManagement #PharmaInnovation #PatientSafety #BostonEvents #WhySummits