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  • Regulatory Rapporteur - December 2025
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November 2025 – Contents: Human medicines sessions

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Florian Schmidt

HM1: General pharmaceutical legislation – Platform technology and sandbox approaches

By Evyenia Shaili

 

Falk Ehmann

HM2: Fireside chat

By Cristina Dragan

 

Martin Huber

HM3: Applying Artificial Intelligence in real life

By Natasha Bankowski

 

Kora Doorduyn-van der Stoep

HM4: Revision of the EU Variation Regulation – Continuing innovation in lifecycle management

By Jessica Roe

 

Margareth Jorvid

HM5/MD1/IVD1: Programme COMBINE – Accelerating clinical trials and medical innovation in the EU

By Nathalie Boeglin

 

Mónica Perea-Vélez

HM6: How Artificial Intelligence is transforming regulatory approaches towards chemistry, manufacturing and controls (CMC)

By Francisco Baptista

 

Regina Skavron

HM7: First experiences with the HTA Regulation

By Andrea Laslop

 

Katja Pečjak Reven

HM8: ePI is on FHIR – Preparing for implementation

By Frank Vandendriessche

 

Jens Reinhardt, Christine Grew and Ralf Sazenbacher

HM9: From barrier to bridge – Practical strategies for successful advanced therapy medicinal product (ATMP) development

By Bruno Speder

 

Claudia Riedel

HM10: Strengthening Europe’s clinical trials competitiveness

By Nathalie Boeglin

 

 

Topics

  • Advanced therapy medicinal products (ATMPs)
  • Artificial intelligence (AI)
  • Chemistry, manufacturing and controls (CMC)
  • Clinical trial
  • COMBINE
  • Electronic product information (ePI)
  • EU general pharmaceutical legislation (GPL)
  • EU HTA Regulation
  • European Medicines Agency (EMA)
  • Pharmaceuticals
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