Workshops

Below are links to workshops for which there are archived files such as presentation slides and audio, where applicable. Information about upcoming workshops and events is available online.

Upcoming Events
November 15, 2024 NonprescriptionAnalgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age
September 6, 2024 ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients
July 11-12, 2024 Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products
May 8-9, 2024 Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment
November 30 - December 1, 2023 Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients
October 30, 2023 Defining “Candy-Like” Nonprescription Drug Products
October 17, 2023 Prediction of Oral Drug Absorption & Biopharmaceutic Risk Using a Dissolution-Hollow Fiber Membrane
August 29 - 31, 2023 Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality
May 23-24, 2023 Drug Dissolution in Oral Drug Absorption Workshop
May 11, 2023 Creating a Roadmap to Quantitative Systems Pharmacology-Informed Rare Disease Drug Development Workshop
February 17, 2023 Application of Artificial Intelligence & Machine Learning for Precision Medicine
November 9, 2022 Bridging Drug Efficacy and Safety to the Obese: Considerations and Scientific Approaches
July 13-14, 2022 Co-Processed API Workshop
May 16, 2022 Pharmacokinetic Evaluation in Pregnancy
April 13, 2022 Biosimilars: A Decade of Experience and Future Directions
January 26, 2022 IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes
December 6, 2021 Drug Permeability: Best Practices for BCS-based Biowaivers 
October 21-22, 2021 Fetal Pharmacology and Therapeutics
October 13-14, 2021 Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Under Age 2
September 1-2, 2021 Advancing the Development of Pediatric Therapeutics
February 10, 2021 Collaborating to Advance Health Equity for Diabetes and Chronic Kidney Disease
October 22, 2020 Pediatric Dose Selection
October 8, 2020 Assessing Changes in Pharmacokinetics of Drugs in Liver Disease
August 14, 2020 3D Cell Culture Models for Drug PK, Safety, and Efficacy Assessment
July 23-24, 2020 Topical Drug Development: Evolution of Science and Regulatory Policy II

Please see below for events held prior to 2020.

November 12-14, 2019 Clinical Investigator Training Course: Regulatory Education for Industry 
October 2, 2019 Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
September 23-25, 2019 Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product
July 29-30, 2019 Topical Drug Development — Evolution of Science and Regulatory Policy
June 18-19, 2019 Pediatric Formulation Development: Challenges of Today and Strategies for Tomorrow
May 21-22, 2019 In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, and When
May 16, 2019 Pediatric Ontogeny: Ready for Incorporation into Modeling in Pediatric Drug Development?
February 28, 2019 Pediatric Clinical Investigator Training Course
November 16, 2018 Pediatric Inflammatory Bowel Disease (IBD) Workshop
November 13-15, 2018 2018 Clinical Investigator Training Course
October 3-4, 2018 Predictive Immunogenicity for Better Clinical Outcomes
November 7-9, 2017 2017 Clinical Investigator Training Course

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