IFAPP – THE NEW EU PHARMACEUTICAL FRAMEWORK: WHAT IT MEANS AND WHAT COMES NEXT
Date: Thursday, 15 October 2026
Time schedule:
12.00 – 13.00 PM CEST
06.00 – 07.00 AM EDT
07.00 – 08.00 PM JST
CONTENT
The webinar will give highlights of the changes in the EU pharmaceutical legislation.
The new EU pharmaceutical legislation represents the most significant reform of Europe’s pharmaceutical regulatory framework in more than two decades. With the legislative negotiations concluding, attention is now shifting from the political agreement to implementation and to what the new framework will mean in practice for medicines development and regulation in Europe.
The webinar will provide an overview of the key changes introduced by the new legislation and explore the opportunities and challenges arising during implementation. It will consider where implementation choices can make a meaningful difference, also in relation to regulatory pathways, scientific interactions, simplification, digitalisation and the functioning of the European regulatory system.
Drawing on the industry perspective, the session will also consider what successful implementation should ultimately deliver and how the reform can contribute to a faster, more predictable,connected and future-proof regulatory environment for medicines in Europe.
SPEAKER
KATARINA NEDOG is Director Regulatory Policy at the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing Europe’s research-based pharmaceutical industry. She joined EFPIA in September 2023 and took up her current role in June 2025. Her work focuses on regulatory policy across the medicines lifecycle, including clinical trials, preclinical development, pharmacovigilance, and drug development, with a strong emphasis on supporting innovation while safeguarding patient safety.
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