NOVEMBER 2025 | VOL. 22 | NO. 10
TOPRA Symposium 2025: Leading with impact
This issue reports on the human medicine, medical device, IVD and veterinary medicine sessions from the 2025 TOPRA Symposium.
HM1: General pharmaceutical legislation - Platform technology and sandbox approaches
This is a report of the HM1 session that took place at this year’s Symposium.
HM2: Fireside chat
This is a report of the HM2 session that took place at this year’s Symposium.
HM3: Applying Artificial Intelligence in real life
This is a report of the HM3 session that took place at this year’s Symposium.
HM4: Revision of the EU Variation Regulation – Continuing innovation in lifecycle management
This is a report of the HM3 session that took place at this year’s Symposium.
HM5/MD1/IVD1: Programme COMBINE – Accelerating clinical trials and medical innovation in the EU
This is a report of the HM5/MD1/IVD1 session that took place at this year’s Symposium.
HM6: How Artificial Intelligence is transforming regulatory approaches towards chemistry, manufacturing and controls (CMC)
This is a report of the HM6 session that took place at this year’s Symposium.
HM7: First experiences with the HTA Regulation
This is a report of the HM7 session that took place at this year’s Symposium.
HM8: ePI is on FHIR – Preparing for implementation
This is a report of the HM8 session that took place at this year’s Symposium.
HM9: From barrier to bridge – Practical strategies for successful advanced therapy medicinal product (ATMP) development
This is a report of the HM9 session that took place at this year’s Symposium.
HM10: Strengthening Europe’s clinical trials competitiveness
This is a report of the HM10 session that took place at this year’s Symposium.
MD2/IVD2: Clinical investigation with medical devices
This is a report of the MD2/IVD2 session that took place at this year’s Symposium.
MD3/IVD3: A global snapshot – Non-EU regulatory updates for medical devices and IVDs
This is a report of the MD3/IVD3 session that took place at this year’s Symposium.
MD4/IVD4: Bridging the gaps – Developments in medical device and IVD regulatory harmonisation
This is a report of the MD4/IVD4 session that took place at this year’s Symposium.
IVD5: Navigating conformity assessment for IVDs – Challenges and opportunities
This is a report of the HM5/MD1/IVD1 session that took place at this year’s Symposium.
MD5: The evolution of the EU Medical Device Regulation
This is a report of the MD5 session that took place at this year’s Symposium.
IVD6: The evolution of the In Vitro Diagnostic Regulation
This is a report of the IVD6 session that took place at this year’s Symposium.
MD6: The importance of digital health – Digital Health Applications (DiGA) and the Digital Mental Health Technology Project
This is a report of the MD6 session that took place at this year’s Symposium.
IVD7: EU reference laboratories under the IVDR – One year on
This is a report of the IVD7 session that took place at this year’s Symposium.
MD7: Updates on Artificial Intelligence legislation and policy
This is a report of the MD7 session that took place at this year’s Symposium.
IVD8: The hunt for evidence – An IVD perspective
This is a report of the IVD8 session that took place at this year’s Symposium.
MD8: Post-market challenges for medical devices
This is a report of the MD8 session that took place at this year’s Symposium.
VM1: Meeting the objectives of the Veterinary Regulation
This is a report of the WM1 session that took place at this year’s Symposium.
VM2: Regulatory updates
This is a report of the VM2 session that took place at this year’s Symposium.
VM3: Regulatory updates in veterinary pharmacovigilance – Navigating evolving challenges
This is a report of the VM3 session that took place at this year’s Symposium.
VM4: The latest EU and international developments in Good Manufacturing Practice
This is a report of the VM4 session that took place at this year’s Symposium.
VM5: Regulatory considerations for novel veterinary therapies – Antimicrobials, immunologicals and biologicals
This is a report of the VM5 session that took place at this year’s Symposium.
VM6: Transitioning to animal-free chemical safety testing for veterinary medicines
This is a report of the VM6 session that took place at this year’s Symposium.
PS1: Tailored development of biosimilars without efficacy and safety studies – Is this the future?
This is a report of the PS1 session that took place at this year’s Symposium.
PS2: Navigating the green horizon – Environmental sustainability and regulatory affairs
This is a report of the PS2 session that took place at this year’s Symposium.
SME1: Regulatory updates for SMEs, academia and start-ups
This is a report of the SME1 session that took place at this year’s Symposium.
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