Committee for Advanced Therapies (CAT) meeting with interested parties

• Date:
  Tuesday, 26 October 2021
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

CAT engages in active dialogue with its interested parties on a regular basis. During its October 2021 annual meeting CAT and its interested parties discussed the following scientific topics: CAT activities, ATMP lifecycle support and patient access; comprehensiveness of clinical data in marketing authorisations; GMO/ERA in clinical trials and marketing authorisations; EMA-FDA parallel advice; The new HTA regulation; ATMPs and Real World Evidence. Other issues and questions from the participating interested parties were also addressed.

Documents

Agenda - Committee for Advanced Therapies (CAT) meeting with interested parties - October 2021

Minutes - Committee for Advanced Therapies (CAT) meeting with interested parties - October 2021

Reference Number: EMA/582731/2021

ATMP lifecycle support and patient access

CHMP-CAT inter-committee ad hoc working group on comprehensiveness of clinical data in marketing authorisations (Maura O’Donovan)

ATMPs submissions (Ana Hidalgo-Simon)

EMA-FDA parallel scientific advice (PSA)

GMO / ERA in clinical trials (Tomas Boran)

GMO / ERA in marketing authorisation applications of ATMPs containing GMOs (Patrick Celis)

Real world evidence (data) in CAT decision making (Kieran Breen)

New HTA regulation: key elements and next steps (Flora Giorgio)

Update on real-world evidence and DARWIN EU (Gianmario Candore)