SPEAKERS

Director, Combination Product & Device, Biopharmaceutical Development and Engineering

Manager, Policy Development

Head of Commercial Strategy

Senior Director, Global Regulatory Affairs

Senior Chemist, DPQAVII, OPQAII, OPQ

Manager

Director, Supplier Services

Senior Scientific Reviewer

Associate Director, Regulatory Affairs Strategy and Science, Biosimilars

Program Director, Trade Relations

Senior Director, Biosimilars Regulatory Affairs

Managing Partner

Associate Director, Regulatory Devices

Director, Division of Product Quality Assessment X (DPQA X), OPQA II, OPQ, CDER

Senior Research Scientist, Analytical R&D

Senior Director, Policy

Director, Public Policy

Visiting Fellow, Economic Studies, Center on Health Policy

Senior Director of Occupational & Environmental Sciences

Senior Director, Regulatory Affairs

Senior Director, Global Quality Audits and Compliance

Director, DPMAVI, OPMA, OPQ,CDER

Vice President, Global API R&D

Partner

Director, Specialty Clinical Solutions

Acting Division Director, Division of Quantitative Methods & Modeling (DQMM), Office of Research and Standards (ORS), OGD, CDER

Vice President, Advocacy & Government Affairs

Senior Advisor, Division of Clinical Review, Office of Safety and Clinical Evaluation, OGD, CDER

Senior Advisor

Senior Vice President, Head of Legal and Intellectual Property, Biopharmaceutical

Director, Regulatory Affairs Policy U.S.

Associate Director, Regulatory Affairs Biosimilars

Senior Scientific Advisor, Office of Quality Surveillance (OQS), OPQ, CDER

Board Chair

Chief Legal & Intellectual Property Officer

Associate Director for Global Regulatory Affairs, Immediate Office, OGD, CDER

Associate Director, Stakeholder Engagement and Education, OTBB, CDER

Supervisory Regulatory Health Project Manager, Division of Regulatory & Business Process Management II, OPRO, OPQ, CDER

Senior Director, Global Regulatory Affairs PLCM & Regulatory Compliance

Senior Director and Head of Regulatory Generics Development

Deputy General Manager, Scientific Regulatory Excellence

Senior Director

Senior Portfolio Head Regulatory Devices

General Manager, API Regulatory & Business Continuity

Director

Health Insurance Specialist

Executive Director of the Biosimilars Council

Regulatory Devices Portfolio Head

Deputy Director, Division of Pharmacology/Toxicology Review, Office of Safety and Clinical Evaluation, OGD, CDER

Director

Deputy Director, OGD, CDER

Senior Vice President, Global Regulatory Affairs

Associate Vice President, Head of Analytical Sciences

Senior Director, Sciences and Regulatory Affairs

Senior Pharmaceutical Quality Assessor, Division of Products Quality Assessment I (DPQAI), OPQA I, OPQ, CDER

Head Regulatory Devices

Chair, Hatch-Waxman & Biologics

Combination Products Regulatory Advisor and Product Jurisdiction Officer, CDER

Director, Division of Drug Delivery, General Hospital Devices, and Human Factors, Office of Health Technology 3, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)

Director, ORS, OGD, CDER

Commissioner

Director

Senior Vice President & Head Of Global Regulatory & Business Continuity

Lead of Regulatory Affairs, US

Vice President, Global Quality Compliance

Vice President, Chief Regulatory Counsel & Head, Global Regulatory Policy

Senior Vice President, Biosimilars & Branded Oncology

Acting Deputy Associate Commissioner for Inspections and Investigations (DACII)

Director

President and CEO

Specialist in Regulation and Health Surveillance, General Management of Biological Products (GGBIO)

Lead Pharmacologist, DTPI, ORS, OGD, CDER

Vice President, Supply Chain Resilience

Associate Director, MS&T, External Manufacturing

AVP, MSTG, Regulatory & Business Continuity

Senior Chemist, Division of Therapeutic Performance I, Office of Research Standards, OGD, CDER

Manager, Regulatory Affairs Biosimilars

Chief Executive Officer

Professor

Associate Director, CMC – Biosimilars & Specialty, Global R&D

Senior Vice President, Sciences and Regulatory Affairs

Senior Director of Pharmaceutical Sciences General Chapters & Complex Generics,

Director, Scientific Review Staff, OTBB, OND, CDER

Regulatory Devices Manager

Supervisory Pharmaceutical Scientist, DPQAX, OPQAII, OPQ, CDER

Director, Division of Project Management, Office of Regulatory Operations (ORO), OGD, CDER

Senior Director, Policy

Director, Regulatory Affairs

Global Head Regulatory Affairs Policy

Chair, QbD/Composition Committee, IPEC-Americas

Retired Director, Division of Post-Marketing Activities II, OLDP, OPQ, CDER

Co-Director, CRCG, Professor, Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics, Department of Pharmaceutical Sciences

Executive Director

Head of Regulatory Affairs Leads, Biosimilars

Senior Director - Global Regulatory Affairs – Liquids, Biosimilars and Specialty Dosage Forms

Supervisory Pharmaceutical Scientist, DPQAIV, OPQAI, OPQ, CDER

Special Counsel

Director, Policy

Deputy Director, Office of Human and Animal Drug Inspectorate, OII

Partner

Chief Medical Officer

Senior Vice President

Partner and Life Sciences Industry Group Co-Leader

Policy Staff Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER

Senior Vice President, Regulatory Affairs

Deputy Director, Office of Safety and Clinical Evaluation (OSCE), OGD, CDER

Global Vice President, Biosimilars Regulatory Affairs

Global Head Clinical Development

Global Head of Regulatory Affairs

Senior Director, Regulatory Affairs, Complex Gx

Director, Formulation Research and Development

Director, Division of Pharmaceutical Quality Research V

Director, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, CDER

Director, Division of Filing Review, Office of Regulatory Operations, OGD, CDER