Mechanism of Action (MoA) PIPs Webinar
State of Play & Implementation in Oncology
With the EU pharmaceutical legislation now adopted, the new Mechanism‑of‑Action (MoA) Paediatric Investigation Plan (PIP) requirements are expected to take effect in 2028/2029. This EFGCP follow‑up webinar will officially launch the EFGCP summary report from the Mechanism of Action workshop held on 1 October 2025, highlighting key scientific and operational insights from regulators, clinicians, and industry.
The session will be opened and closed by Martine Dehlinger Kremer (EFGCP Children Medicines WP Co-Chair) and will feature presentations by Gesine Bejeuhr (EFGCP Children Medicines WP) and Martine Dehlinger Kremer. Updates on the latest developments and an outlook on next steps will be provided by Dominik Karres (EMA) and Karel Allegaert (KU Leuven).
Webinar Outline
Purpose
This follow‑up webinar formally launches the summary report from the 2025 EFGCP MoA workshop/webinar, and it takes stock of the newly adopted EU pharmaceutical legislation and the forthcoming MoA‑PIP requirements (effective 2028/ 2029).
Programme
| 13:00 |
Welcome & framing
Martine Dehlinger-Kremer, UCB Biosciences
|
| 13:10 |
“Where we are now” — legislative + implementation landscape
Gesine Bejeuhr, Bayer
|
| 13:20 |
Featured talk — EMA perspective (Oncology focus)
Dominik Karres, EMA
|
| 13:40 |
Short panel intervention — reflections & “what good looks like”
Karel Allegaert, KU Leuven
|
| 13:45 |
Moderated audience Q&A |
| 13:58 |
Closing & next steps
Martine Dehlinger-Kremer, UCB Biosciences
|
| 14:00 |
End of Webinar |