ROUNDTABLE How Emerging US and EU Regulations Impact your Product Development Strategy?
Wednesday, May 31, 2023 02:15 PM - 03:15 PM
Room 243
Regulation & Reimbursement
Roundtable
How will new regulatory directives, guidance, programs and clinical trial regulations impact product development in the EU, UK, and US?
Moderator
Michael Mendicino, PhD, Owner/President, Chief Consultant & Advisor, Hybrid Concepts International, USA
Panelists
Ilona Reischl, PhD, Chair, EMA Committee for Advanced Therapies, Austria
Mo Heidaran, PhD, Head of Regulatory and Translational Strategy , GC Therapeutics, USA
Paula Salmikangas, PhD, Director of Biopharmaceuticals and ATMP, NDA Group AB, Finland
Steven Oh, PhD, Acting Director, Division of Cell Therapy 1 & 2, US Food and Drugs Administration, USA
Session Description
Recent/ongoing regulatory legislation/guidance/related updates intended to improve regulation of CGT/ATMPs, what opportunities they bring for product development, and what challenges may remain, from both the regulator and industry perspectives.
Key Examples:
USA: PDUFAVII, other Acts addressing animal testing and platform technologies, draft Guidance
EMA: Clinical Trial Regulations (CTRs), Regulations on Substances of Human Origin (SoHo), Regulation on Pharmaceuticals (Pharma)
Learning Objectives
Moderator
Michael Mendicino, PhD, Owner/President, Chief Consultant & Advisor, Hybrid Concepts International, USA
Panelists
Ilona Reischl, PhD, Chair, EMA Committee for Advanced Therapies, Austria
Mo Heidaran, PhD, Head of Regulatory and Translational Strategy , GC Therapeutics, USA
Paula Salmikangas, PhD, Director of Biopharmaceuticals and ATMP, NDA Group AB, Finland
Steven Oh, PhD, Acting Director, Division of Cell Therapy 1 & 2, US Food and Drugs Administration, USA
Session Description
Recent/ongoing regulatory legislation/guidance/related updates intended to improve regulation of CGT/ATMPs, what opportunities they bring for product development, and what challenges may remain, from both the regulator and industry perspectives.
Key Examples:
USA: PDUFAVII, other Acts addressing animal testing and platform technologies, draft Guidance
EMA: Clinical Trial Regulations (CTRs), Regulations on Substances of Human Origin (SoHo), Regulation on Pharmaceuticals (Pharma)
Learning Objectives
- What is currently implemented and impact?
- How will others be implemented and foreseen impact?
- Are these enough?
- What issues may remain?
Michael Mendicino PhD
Owner/President, Chief Consultant & Advisor
Hybrid Concepts International
Moderator
Owner/President, Chief Consultant & Advisor
Hybrid Concepts International
Moderator
