European Regulatory Affairs Forum 2025

MAY 21

SESSION I – NEW EU VARIATIONS FRAMEWORK
The European Commission has revised the rules governing the procedures for post-authorisation changes to the terms of a marketing authorisation for medicinal products for human use.
The amendment of the EC Variations Regulation 1234/2008 and the Variations Classification Guideline aims to make the lifecycle management of medicinal products for human use more efficient and aligned with evolving technology and regulatory needs.
Representatives from regulatory bodies and pharmaceutical companies will share new challenges and first experiences with the implementation of this new regulation in the product lifecycle.
Key discussion points:
• Updates on post-authorization changes and procedures for medicinal products for human use
• New challenges and first experiences of the application of this new regulation from regulatory bodies and pharma companies
• Implications for product lifecycle management

SESSION II – SHORTAGES AND CRITICAL MEDICINES ACT: WHAT FUTURE?
The shortage of essential medicines is currently a priority issue for the EU and is part of the agenda of the first 100 days of the new European Commission.
The Critical Medicines Act aims to address serious shortages of essential medicines such as antibiotics, insulin and painkillers in the EU and make the supply of active ingredients more predictable, reducing dependence on foreign countries.
The representatives from Regulatory bodies and pharma companies will share first experiences of the new platform and the future challenges and the measures for reducing the shortage problem.
Key discussion points:
• Future challenges and measures for reducing the medicine shortages and supply chain vulnerabilities
• Regulatory measures to mitigate risks
• Future strategies for ensuring a stable supply of critical medicines

MAY 22

SESSION III – NAVIGATING AND DISCUSSING THE NEW HTA REGULATION AND JOINT CLINICAL ASSESSMENTS
The introduction of the HTA Regulation (HTAR) in 2022 marks a significant milestone in the field of Health Technology Assessment (HTA).
Join us as we explore how this new legislation heralds a new era in evaluating the joint clinical assessment of pharmaceuticals and medical devices.
What do the joint clinical assessments (JCA) in Europe mean for pharma or MedTech companies?
Key discussion points:
• Implications of Joint Clinical Assessments (JCA) for pharma and MedTech companies
• Keynote presentations by experts in the field
• Interactive panel discussion with speakers and delegates

SESSION IV – CTR: AFTER 3 YEARS SINCE THE IMPLEMENTATION – EXPERIENCES AND UNMET EXPECTATIONS
With the implementation of the CTR, the European Union aimed to increase the efficiency of clinical trials, by stimulating innovation and research, reducing duplication of assessments, creating a favourable environment for conducting clinical trials in the EU, harmonising assessment
rules and processes with higher safety standards and increasing transparency, via the Clinical Trials Information System (CTIS).
After 3 years of CTR implementation and the go live of CTIS, what are the results? Are there some expectations not yet fulfilled?
The session will feature keynote presentations offered by representatives from Regulatory Bodies and from pharma industry for a final panel discussion with the involvement of speakers and delegates.
Key discussion points:
• Achievements and challenges after three years of implementation
• Unmet expectations and areas for improvement