CRED Course: Regulatory Challenges of Successfully Developing ATMPs

12.45 Discussion •

Delegates have the chance to share experiences and ask questions

13.00 Lunch Chair: Alexis Cockcroft, GlaxoSmithKline 14.00 Experience in Clinical Development of ATMPs • General requirements for ATMPs • Experience with ATMP clinical trials • Regulatory challenges of ATMP CTAs • GCP guidelines for ATMPs

Bridget Heelan PAREXEL International

14.45 Environmental Risk Assessments for GMOs in Clinical Trials • Classification of GMOs • CTAs and the diversity of requirements across the EU

Julie Foulkes Freelance Regulatory Affairs Advisor

15.15 Tea and Coffee Chair: Alison Wilson, Cell Data Services 15.30 Regulatory Challenges and Pitfalls •

Bj ӧ rn Carlsson

Non-clinical assessment and issues of relevant models • Experience to date with ATMPs • ATMP procedures • EMA advisory support – what does the future hold • Common issues with assessments

LÄKEMEDELSVERKET Medical Products Agency

16.15 Discussion •

Delegates have the chance to share experiences and ask questions

16.45 Close of Day

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