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  • Regulatory Rapporteur - October 2026
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      ICH Q6(R1): Harmonising specifications for chemical and biological products
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      The compounding pharmaceutical data gap: The impact of structural under-representation on AI-augmented pharmacovigilance systems
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      Moving towards one global paediatric development plan
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      From regulation to implementation: Medical device serialisation and traceability in India
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      Medical device standards update: July 2026
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Medical devices

November 2025 – Contents: Medical devices/IVD sessions

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Write to the Editor at publications@topra.org

 

Margareth Jorvid

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

By Nathalie Boeglin

 

Ulf Schriever

MD2/IVD2: Clinical investigation with medical devices

By Charlotte Holleran

 

MD3/IVD3: A global snapshot – Non-EU regulatory updates for medical devices and IVDs

By Célia Cruz

 

Natasha Bankowski_MD4 IVD4

MD4/IVD4: Bridging the gaps – Developments in medical device and IVD regulatory harmonisation

By Erica Cypas

 

Alex Laan

IVD5: Navigating conformity assessment for IVDs – Challenges and opportunities

By Natasha Bankowski

 

Ashleigh Batchen

MD5: The evolution of the EU Medical Device Regulation

By Célia Cruz

 

Ashleigh Batchen and Steffen Luckner

IVD6: The evolution of the In Vitro Diagnostic Regulation

By Hasnaa Fatehi

 

Wolfgang Lauer, Henrik Emmert and Holly Coole_MD6

MD6: The importance of digital health – Digital Health Applications (DiGA) and Digital Mental Health Technology Project

By Steve Lee

 

Alex Laan_IVD7

IVD7: EU reference laboratories under the IVDR – One year on

By Claire McDonald

 

Felicity Ellis

MD7: Updates on Artificial Intelligence legislation and policy

By Hasnaa Fatehi

 

Antonella Lombardi and Carlos Galamba

IVD8: The hunt for evidence – An IVD perspective

By Margareth Jorvid

 

Nikhil Khadabadi__MD8

MD8: Post-market challenges for medical devices

By Rachel Drapela

 

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)
  • Medical Devices
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    From gatekeepers to collaborators: Regulatory evolution toward risk-based lifecycle approaches in an era of innovation

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    Regulatory Rapporteur October 2026 – Contents

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