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Thursday June 18, 2026 8:00am - 9:00am EDT
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-653-L04-P; CME 1.00; RN 1.00

We will focus on insights regarding implementation of the ASAP process, how it has been beneficial to implement, and results from a survey across a targeted sample of forward-thinking pharma companies (big and small).

Learning Objectives

Describe the steps to implement the ASAP process at a smaller company with limited resources; Identify specific effficiencies achieved when applying the ASAP process to platform products or product families with shared componentts; Recognize how the ASAP process has been beneficial to implement for various projects.

Chair

Greg Ball, PHD

Speaker

Insights Regarding Implementation of the ASAP Process
Barbara Hendrickson, DrMed, MD

Advantages of Earlier Systematic and Strategic Safety Planning
Famina Hemani, PHARMD

Practical Implementation of ASAP Concepts
Shital Patel, PHARMD

Practical Implementation of ASAP Concepts
Cynthia McShea, MPH


Speakers
FH

Famina Hemani

Vice President, Head of Pharmacovigilance, Tourmaline Bio, United States
Famina Hemani, PharmD, is a Pharmacovigilance leader with over 20 years of experience in pharmacy and biopharma, including more than a decade in strategic safety leadership. She has built and scaled PV functions from early clinical development through pre-commercialization across... Read More →
FH

Famina Hemani

Vice President, Head of Pharmacovigilance, Tourmaline Bio, United States
avatar for Cynthia McShea

Cynthia McShea

Head, Safety Statistics, UCB Biosciences, United States
Cindy McShea received a BS in Mathematics from East Carolina University in North Carolina, USA and completed an MPH in Biostatistics from the University of North Carolina at Chapel Hill in North Carolina, USA. Cindy is a senior director of Biostatistics at UCB Biosciences where she... Read More →
SP

Shital Patel

Associate Safety Lead, UCB, United States
SP

Shital Patel

Associate Safety Lead, UCB Biosciences, United States
Thursday June 18, 2026 8:00am - 9:00am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session

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