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                Advancing Regulatory Science

Advancing Regulatory Science

                        Regulatory Science Extramural Research and Development Projects
          Advancing Regulatory Science News and Upcoming Events
          Centers of Excellence in Regulatory Science and Innovation (CERSIs)
          Past News and Events - Advancing Regulatory Science


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          CERSI Workshops and TrainingAdvancing Regulatory Science CERSI Workshops and Training
  
  	
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    PrintAttendees and Presenters at CERSI Workshops and Meetings

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

January 7, 2024: 5th CERSI Innovations in Regulatory Science Summit (University of California, San Francisco (UCSF)-Stanford CERSI)Past Events

2023 Workshops and Training
	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    
2022 Workshops and Training
	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)    
2021 Workshops and Training
	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)
	February 10, 2021: Collaborating to Advance Health Equity for Diabetes and Chronic Kidney Disease (University of Maryland CERSI Workshop)
	January 10, 2021: Innovations in Regulatory Science Virtual Summit (University of California, San Francisco (UCSF)-Stanford CERSI)    
2020 Workshops and Training
	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)    
2019 Workshops and Training
	November 12-14, 2019: Regulatory Education for Industry (REdI): Clinical Investigator Training Course (FDA CDER and University of Maryland CERSI Collaborative Training Course)
	October 2, 2019: Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA) Workshop (pJIA and University of Maryland CERSI Collaborative Workshop)
	September 23-25, 2019: Regulatory Education for Industry (REdI) and CERSI Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls (FDA CDER, Small Business and Industry Assistance (SBIA), 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)    
2018 Workshops and Training
	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)    
2017 Workshops and Training
	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)    
2016 Workshops and Training
	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)    
2015 Workshops and Training
	December 2, 2015: Clinical Trials: Assessing Safety and Efficacy for a Diverse Population (FDA-Johns Hopkins University Co-sponsored Conference)
	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)

                                                                                  Content current as of:
      12/05/2023
              
              
Topic(s)
			  Training & EducationAdvancing Regulatory Science

          
                        Regulatory Science Extramural Research and Development Projects
          Advancing Regulatory Science News and Upcoming Events
          Centers of Excellence in Regulatory Science and Innovation (CERSIs)
          Past News and Events - Advancing Regulatory Science


                        Focus Areas of Regulatory Science Report
 
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