CERSI Workshops and Training
The following is a list of upcoming and past CERSI workshops and training co-sponsored by FDA and CERSI academic institutions or held by those individual universities.
Upcoming Events
Past Events
- September 6, 2024: ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients (University of Maryland CERSI)
- July 11-July 12, 2024: Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products (University of Maryland CERSI)
- May 8, 2024 and May 9, 2024: Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment (University of Maryland CERSI)
- May 3, 2024: 2024 Yale-Mayo Clinic CERSI Scholar Virtual Research Seminar (Yale University-Mayo Clinic CERSI)
- January 8, 2024: 2024 CERSI Scientific Symposium (University of California, San Francisco (UCSF)-Stanford CERSI)
- January 7, 2024: 5th CERSI Innovations in Regulatory Science Summit (University of California, San Francisco (UCSF)-Stanford CERSI)
- November 30 - December 1, 2023: Advancing the Development of Pediatric Therapeutics (ADEPT) 8 Workshop on Drug Dosing in Pediatric Patients with Renal Impairment (University of Maryland CERSI)
- October 30, 2023: Defining 'Candy-Like' Nonprescription Drug Products (University of Maryland CERSI)
- May 11, 2023: Creating a Roadmap to Quantitative Systems Pharmacology-informed Rare Disease Drug Development (University of Maryland CERSI)
- May 5, 2023: 2023 Yale-Mayo Clinic CERSI Scholar Virtual Research Seminar (Yale University-Mayo Clinic CERSI)
- May 2-3, 2023: Addressing Challenges in the Design and Analysis of Rare Disease Clinical Trials: Considerations and Tools (Johns Hopkins University CERSI)
- February 17, 2023: Application of Artificial Intelligence & Machine Learning for Precision Medicine (University of Maryland CERSI)
- January 8, 2023: The 2023 Innovations in Regulatory Science Summit, Accelerating Healthcare Innovation Through a Regulatory Lens, University of California, San Francisco (UCSF)-Stanford CERSI Webinar
- November 9, 2022: Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches (University of Maryland CERSI)
- July 13-July 14, 2022: Co-Processed API (University of Maryland CERSI)
- May 16-May 17, 2022: Pharmacokinetic Evaluation in Pregnancy (University of Maryland CERSI)
- May 9, 2022: Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation (Johns Hopkins University CERSI)
- May 6, 2022: 2022 Yale-Mayo Clinic CERSI Scholar Virtual Research Seminar (Yale University-Mayo Clinic CERSI) Part 1, Part 2, Part 3
- April 13, 2022: Biosimilars: A Decade of Experience and Future Directions—Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology (University of Maryland CERSI)
- February 4, 2022: America’s Got Regulatory Talent Competition (University of Maryland CERSI)
- January 26, 2022: IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes (University of Maryland CERSI and Johns Hopkins University CERSI)
- January 9, 2022: The 2022 Innovations in Regulatory Science Summit, Movers and Shapers: The Future of Drug and Device Development (University of California, San Francisco (UCSF)-Stanford CERSI)
- December 6, 2021: Drug Permeability: Best Practices for BCS-based Biowaivers (Virtual) (University of Maryland CERSI)
- November 9, 2021: Artificial Intelligence and Causality: Estimating Heterogeneous Treatment Effects, Interpretability and Explainability (Yale University-Mayo Clinic CERSI),Recording
- October 26, 2021: Prenatal Somatic Cell Gene Therapies: Charting a Path Forward for Clinical Applications (University of California, San Francisco (UCSF)-Stanford CERSI)
- October 21-22, 2021: "Fetal Pharmacology and Therapeutics" Workshop (University of Maryland CERSI)
- October 13-14, 2021: Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Under Age 2 (University of Maryland CERSI)
- September 1-2, 2021: Advancing the Development of Pediatric Therapeutics ADEPT 7 (University of Maryland CERSI Workshop)
- March 9, 2021: IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes (Yale University – Mayo Clinic CERSI)
- January 10, 2021: Innovations in Regulatory Science Virtual Summit (University of California, San Francisco (UCSF)-Stanford CERSI)
- October 22 & 23, 2020: Pediatric Dose Selection (University of Maryland CERSI Workshop)
- October 8, 2020: Assessing Changes in Pharmacokinetics of Drug in Liver Disease (University of Maryland CERSI Workshop)
- August 14, 2020: 3D cell culture models for drug safety and efficacy assessment (University of Maryland CERSI Workshop)
- July 28, 2020: IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes (University of California, San Francisco (UCSF) – Stanford University CERSI)
- July 23-24, 2020: Topical Drug Development—Evolution of Science and Regulatory Policy (DAY 2) (University of Maryland CERSI Workshop)
- January 12, 2020: Innovations in Regulatory Science Summit (University of California, San Francisco (UCSF)-Stanford CERSI)
- October 2, 2019: Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA) Workshop (pJIA and University of Maryland CERSI Collaborative Workshop)
- July 29-30, 2019: Topical Drug Development-Evolution of Science and Regulatory Policy (University of Maryland CERSI Workshop)
- June 18-19, 2019: Pediatric Formulation Development: Challenges of Today and Strategies for Tomorrow (University of Maryland CERSI Workshop)
- May 21-22, 2019: Methods to Assess Similarity in Dissolution Profiles in Support of Drug Product Quality: What, How, and When (University of Maryland CERSI Workshop)
- May 16, 2019: Pediatric Ontogeny: Ready for Incorporation into Modeling in Pediatric Drug Development? (FDA CDER, NIH National Cancer Institute and University of Maryland CERSI Collaborative Workshop)
- February 28, 2019: Pediatric Clinical Investigator Training Workshop, (FDA and University of Maryland CERSI Collaborative Workshop)
- November 28, 2018: Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities (FDA and Johns Hopkins University Collaborative Symposium)
- November 16, 2018: Pediatric Inflammatory Bowel Disease (FDA CDER and University of Maryland CERSI)
- November 13-15, 2018: Clinical Investigator Training Course (FDA CDER and University of Maryland CERSI Collaborative Training Course)
- October 29, 2018: Clinical Trials to Optimize Outcomes in Early Breast Cancer (FDA Oncology Center Of Excellence (OCE) and UCSF-Stanford CERSI Collaborative Workshop)
- October 3-4, 2018: Predictive Immunogenicity for Better Clinical Outcomes (FDA, Johns Hopkins University CERSI and University of Maryland CERSI Collaborative Workshop)
- September 28, 2018: Translational Pathways for Optical Drugs and Devices for Cancer Imaging (FDA CDER and CDRH, NIH National Cancer Institute and University of Maryland CERSI Collaborative Workshop)
- September 14-15, 2018: Real World Evidence, Globalization and Regulatory Science (FDA CDER, University of Maryland Baltimore County, Stanford University and University of Maryland CERSI Collaborative Workshop)
- September 12, 2018: Medical Devices - Patient Engagement in Real World Evidence (RWE): Lessons Learned and Best Practices (FDA CDRH and University of Maryland CERSI Collaborative Workshop)
- December 7-8, 2017: Advancing Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation (Collaborative Workshop hosted by: Centers of Excellence in Regulatory Science and Innovation (CERSIs) and The Food and Drug Administration)
- October 27, 2017: Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints (FDA CDER and University of Maryland CERSI Collaborative Workshop)
- June 15, 2017: Use of Natural Language Processing to Extract Information from Clinical Text (FDA, UCSF-Stanford CERSI, and San Francisco State University Collaborative Workshop)
- May 15-17, 2017: Dissolution, Modeling, and Simulation Strategies to Enable Patient-Centered Product Development (University of Maryland CERSI Workshop)
- April 17, 2017: Small Sensors Going Big Places (University of Maryland CERSI Symposium)
- December 5, 2016: Protein Aggregation Measurement in Biotherapeutics: Established and Emerging Techniques (University of Maryland CERSI Workshop)
- November 18, 2016: Substitutability of Generic Drugs: Perceptions and Reality (FDA-Johns Hopkins University CERSI Co-sponsored Workshop)
- November 7-9, 2016: Clinical Investigator Training Course (FDA-University of Maryland CERSI Co-sponsored Event)
- September 23, 2016: Pediatric Master Protocols (FDA-University of Maryland CERSI Co-sponsored Workshop)
- June 8-9, 2016: Challenges and Strategies to Facilitate Formulation Development of Pediatric Drug Products (University of Maryland CERSI Workshop)
- June 1, 2016: Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics (FDA-University of Maryland CERSI Co-sponsored Workshop)
- March 25, 2016: Material Advantage: Pioneering Devices enabled by material breakthroughs (University of Maryland CERSI Symposium)
- March 24, 2016: Building the National Evaluation System for Medical Devices: Using Real World Evidence to Improve Device Safety and Effectiveness (FDA-University of Maryland CERSI Co-sponsored Workshop)
- May 4, 2015: Important Health Factors in Pharmacoepidemiology Studies Relying on Health Care Databases (FDA-University of Maryland CERSI Co-sponsored Workshop)
- March 9, 2015: Patient-Focused Drug Development (FDA-University of Maryland CERSI Co-sponsored Conference)
- January 22, 2015: Pediatric Drug Development: Use of Exposure Matching and Exposure-Response for Extrapolation of Efficacy in Pediatric Product Development (FDA-University of Maryland CERSI Co-sponsored Workshop)