2026 ACCP STEP & ESP Webinar: Exposure Response Analysis Across the Drug Development Continuum: Case Examples from Industry & Regulatory Perspective - LIVE
Includes a Live Web Event on 03/18/2026 at 1:00 PM (EDT)
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2026 ACCP STEP & ESP Webinar: Exposure-Response Analysis Across the Drug Development Continuum: Case Examples from Industry & Regulatory Perspective
Live Session: Wednesday, March 18th, 2026, from 1:00 to 2:00 PM ET
On Demand: March 18th, 2026 to March 18th, 2029
Target audience:
Interprofessional team of MDs, PharmDs, PhDs and other healthcare professionals who are interested in Exposure-Response (E-R) analysis and practical strategies that can be applied within regulatory, industry, and academic settings.
Objectives
After completing this activity, the learner will be able to:
- Identify common challenges and key considerations for implementing E-R analyses in drug development programs;
- Interpret E-R data to inform dosing strategies and support drug development decision-making;
- Discuss the regulatory expectations on implementation of E-R analyses in regulatory reviews;
Description:
This webinar addresses advanced Exposure-Response (E-R) analysis strategies to support industrial drug development and evaluate regulatory expectations through real-world case examples. Learners who complete this activity will enhance their knowledge of advanced E-R analysis, interpreting regulatory expectations and integrating case-based best practices.
Ahmed Salem, PhD
Senior Research Fellow/Senior Director of Clinical Pharmacology & Pharmacometrics
AbbVie, Inc
Ahmed Salem, PhD, FCP is a Senior Research Fellow/Senior Director of Clinical Pharmacology and Pharmacometrics at Abbvie and an adjunct Professor at University of Minnesota. Dr. Salem is a pharmacist and got his PhD in 2010 from the University of Minnesota with a focus on Pharmacometrics and a minor in Biostatistics. In his industry role, Dr. Salem contributed to 15 different FDA and EMA approvals of new drugs, dosage forms or dosage regimens. He has over 230 publications with an i-10 index of 150 and H index of 45 and holds 10 patents in the US and EU. He has worked on over 200 Phase I, II and III clinical trials. Dr Salem is the recipient of the ACCP Tanabe Investigator Award. He was also the recipient of the AAPS High Impact Article Award in addition to other awards and recognition from the IQ-Clinical Pharmacology Leadership Group (CPLG), UMN and AbbVie. He was also selected as a Fellow of ACCP and as a Senior Research Fellow of the Abbvie Community of Science. Dr. Salem has been an invited speaker and chair at multiple conferences such as ACoP, ASCPT, ACCP, FDA workshops.
Hao Zhu, PhD
Director, Division of Pharmacometrics, Office of Clinical Pharmacology
US Food & Drug Administration
Dr. Hao Zhu is the director of the Division of Pharmacometrics, Office of Clinical Pharmacology, at the U.S. FDA. Dr. Zhu also serves as a selection committee member for Model Informed Drug Development, Complex Innovative Trial Design, and Rare Disease Endpoint Advancement meeting programs. His is a member of Digital Health Technology steering committee at the FDA. He is a co-chair for the AI Policy and Review subcommittee at the CDER FDA. Hao is a board member at the newly formed quantitative medicine center of excellence.
Dr. Zhu received his Ph.D. in pharmaceutical sciences and Master in statistics from the University of Florida. Overall, he has more than 20 years of working experience in academia, industry, and regulatory agency. His division reviews the pharmacometrics related submissions and supports pharmacometrics-related policy development.