CRED Course: Regulatory Challenges of Successfully Developing ATMPs

A Workshop on the Regulatory Challenges of Successfully Developing Advanced Therapy Medicinal Products 11 July 2017 TOPRA Office, London

9.00 9.30

Registration

TOPRA Introduction

Samantha Alsbury Head of Professional Development, TOPRA Julie Foulkes Freelance Regulatory Affairs Advisor

9.35

Welcome and Introduction

Chair: Julie Foulkes, Freelance Regulatory Affairs Advisor 9.40 Introduction to ATMPs • What are ATMPs…and what are not • ATMP classification • ATMP- Device combinations • Approved products • Assessment processes • Industrial landscape 10.30 CMC and Quality considerations for ATMPs – Part 1 11.00 Tea and Coffee break 11.15 CMC and Quality considerations for ATMPs – Part 2 Food for Thought (examples of ATMP challenges). • Defining the drug substance • Short shelf life products • Limited product quantities • TSE, CJD, and viral safety • Comparability • Process validation • EU legislation & guidance overview • Pharmacopoeial standards Module 1 & Module 3 guidance •

Alison Wilson Consultant Cell Data Services

Alexis Cockroft Biopharm CMC Regulatory Affairs GlaxoSmithKline

Alexis Cockroft Biopharm CMC Regulatory Affairs

12.00 Non clinical development of ATMPs • General requirements for ATMPs •

Michaela Sharpe Cell & Gene Therapy

Challenges with preclinical development

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