Event Berlin RAPS

Meeting EMA and FDA:
Formal and Informal Pathways in Search of Alignment

Tuesday, May 7, 2024

Arriello speaker at RAPS Euro Convergence in Berlin

Our Principal Consultant, Jayne Hunt, talks on behalf of Valeria Grigoriev, Senior Regulatory Affairs Specialist, about under-utilized informal meetings with EMA and FDA that offer valuable insights for drug development.

As Regulatory Affairs professionals we are familiar with the official meetings offered by the regulatory authorities EMA and FDA and, their importance for adequate drug development. An example of optional meetings offered during various time points in the product life cycle to support the resolution of scientific and regulatory issues is Scientific Advice (SA). 

These meetings in the US are typically referred to, for example as Type, A, B or C meetings. SA is not legally binding on authorities regarding any future marketing authorisation application for the medicine concerned.

In this way, no pre-evaluation of the results of the studies or conclusions on benefit-risk assessments can be granted. And still, the increase in the number of scientific advice requests remains constant. Interestingly, not many Regulatory professionals are familiar with all types of interactions offered by both EMA and FDA. 

Rarely used authority interactions, namely EMA SME briefing meetings and FDA INTERACT or pre-breakthrough meetings, hold significant benefits for drug development, offering a unique opportunity to gain invaluable insights and enhance drug strategies in navigating the regulatory landscape. 

In this session, we will discuss the advantages and disadvantages, pros and cons of SA and informal meetings as well as best practices for the preparation of such meetings. A reflection from a 5-year Parallel (PSA) program review will be presented on whether alignment with EMA and FDA in a PSA meeting is an actually achievable goal. Besides identifying the best candidates and the most suitable development phase to apply, the most noteworthy findings will be emphasized. 

Learning Objectives:

  • Enhance Regulatory Engagement: Understand how Scientific Advice and informal meetings can improve communication and collaboration with regulatory agencies, enabling participants to establish effective lines of communication throughout drug development. Evaluate whether alignment with EMA and FDA is an actually achievable Parallel SA (PSA) meeting goal.

  • Optimize Development Strategies: Establish suitable type of topics and questions to be raised during informal versus Scientific Advice meetings, as well as get the best practices for concluding an exhaustive briefing package. Learn how to tailor drug development plans based on insights gained from regulatory interactions, allowing participants to make informed decisions, mitigate risks, and expedite the development process.

  • Improve Compliance and Quality Assurance: Discover best practices for maintaining compliance and ensuring high-quality standards throughout drug development by applying lessons learned from successful Scientific Advice and informal interactions with the FDA and EMA.

Our representatives.

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Jayne Hunt
Principal Consultant, Regulatory Affairs
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Valeria Grigoriev
Senior Regulatory Affairs Specialist

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