Committee for Advanced Therapies (CAT) meeting with interested parties
Date:
26/10/2021
Location:
Online
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.
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Agenda - Committee for Advanced Therapies (CAT) meeting with interested parties - October 2021 (PDF/213.36 KB)
First published: 08/02/2022 -
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Minutes - Committee for Advanced Therapies (CAT) meeting with interested parties - October 2021 (PDF/241.88 KB)
First published: 08/02/2022
EMA/582731/2021 -
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ATMP lifecycle support and patient access (PDF/296.08 KB)
First published: 08/02/2022 -
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CHMP-CAT inter-committee ad hoc working group on comprehensiveness of clinical data in marketing authorisations (Maura O’Donovan) (PDF/257.74 KB)
First published: 08/02/2022 -
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ATMPs submissions (Ana Hidalgo-Simon) (PDF/125.95 KB)
First published: 08/02/2022 -
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EMA-FDA parallel scientific advice (PSA) (PDF/526.27 KB)
First published: 08/02/2022 -
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GMO / ERA in clinical trials (Tomas Boran) (PDF/1.07 MB)
First published: 08/02/2022 -
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GMO / ERA in marketing authorisation applications of ATMPs containing GMOs (Patrick Celis) (PDF/309.27 KB)
First published: 08/02/2022 -
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Real world evidence (data) in CAT decision making (Kieran Breen) (PDF/568.31 KB)
First published: 08/02/2022 -
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New HTA regulation: key elements and next steps (Flora Giorgio) (PDF/433.16 KB)
First published: 08/02/2022 -
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Update on real-world evidence and DARWIN EU (Gianmario Candore) (PDF/948.52 KB)
First published: 08/02/2022