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Pharmaceuticals

Regulatory Intelligence and Policy Strategy; Dynamic Regulatory Assessment as a Case Study

Wednesday, May 8, 2024
15:40 – 16:40 CEST
Location: A 03 + A 04
Learning Level: Advanced

Description: This combined session will discuss (i) the importance of the interplay between regulatory intelligence and policy integration into business strategy, and (ii) exemplify, by way of a case study – Dynamic Regulatory Assessment (DRA) in Europe - how the two strands can work together to advocate legislative change.

With the ever-changing regulatory environment, rapid pace of innovation in science, big data and the increasing complexity of drug development pathways, the partnering role of regulatory intelligence (RI) is even more critical.

The regulatory intelligence part of this session will provide overview on how to translate regulatory intelligence into strategic decisions. Learnings from this session will allow intermediate and advanced regulatory intelligence professionals to participate in a thoughtful discussion on how to deliver regulatory intelligence, so it can be translated into business strategy and to enhance their own careers.

Dynamic regulatory assessment (DRA) will then be discussed. DRA is an EFPIA initiative linking iterative regulatory dialogue with regular and active evidence submission and assessment, enabled by contemporary IT. Similar concepts have also been called iterative/ phased submissions, and inclusion of phased review concept in the 2023 draft General Pharmaceutical Legislation (GPL) signals a willingness to implement this approach in the European Union.

This session seeks to inform about the development of the DRA concept, which overlaps with phased reviews, including why the time is right to pilot it, to ensure European patients will derive the greatest benefit from inclusion of the phased review concept in the GPL.

Learning Objectives:

  • Better understand the strategic value of regulatory intelligence and policy
  • Recognize the importance of the internal and external network for the RI function on key topics (with examples)
  • Understand the concept of DRA and the potential of phased review in the draft General Pharmaceutical Legislation
  • Understand the need to prioritise a pilot for DRA/phased review with stakeholders