28 January - 15:00 -16:00 GMT / 10:00 - 11:00 EST / 16:00 – 17:00 CET
Top Tips for successful agency meetings

What do you really need to know? Gain a comprehensive understanding of different types of regulatory agency meetings in EU and US and how to set them to make the most of a meeting with regulators. 

Abstract: Regulatory agency interaction occurs from before a candidate drug enters clinical development and all the way to marketing approval and beyond. This presentation will cover (1) types of regulatory meetings that can occur within the EU and US with comment on how to set them and (2) ways for successful interaction in avoiding unfavorable agency feedback by generating relevant questions and preparing a robust Briefing Document for meetings. Further discussion will occur around means for positive interaction during the Clinical Trials Application or Investigational New Drug application stage (and avoiding a clinical hold) up to submission of a Marketing Authorization Application and a New Drug Application or a Biologic License Application. Successful regulatory agency interaction involves robust scientific thinking, proper planning and well-written documentation. Finally, a recent case study will be presented to demonstrate successful regulatory interaction in the US (a FDA end of phase 2 (EOP2) meeting).

Target Audience
Pharmaceutical and Biotech Industry stakeholders, from small to large size companies aiming to engage with regulators to best develop and register their asset globally (with a focus on the EU and US). 

Key words: types of regulatory agency meetings in EU and US, nonclinical and clinical aspects, robust scientific thinking, proper planning and timing, well-written documentation, 

Speaker details
Audrey Finesso, PharmD, MsC, Clinical Regulatory Strategist, Fortrea
Audrey Finesso has 25 years of professional experience in regulatory affairs from industry (pharmaceutical companies and biotech companies) to consultancy. She worked in different global regulatory affairs departments and gained a strong experience in clinical and regulatory strategy, unmet medical needs, life-threatening diseases (onco/hematology) and orphan diseases. She joined the consultancy’s world in 2017 and is currently supporting Pharmaceutical and Biotech Industry stakeholders with the aim to expedite their development programs and interact with key global Regulatory Agencies (EMA, FDA, National Agencies) through different regulatory/expedite pathways.

Paul Baldrick is Executive Director, Nonclinical Regulatory Strategy within the Product Development and Market Access Consulting group, Fortrea (formerly Labcorp and Covance)
Paul Baldrick is based in the UK; he has a BSc (1983) and PhD (1988) from Durham University, UK. Professor Baldrick is also Visiting Chair (Regulatory Toxicology) of the Lincoln School of Pharmacy, College of Science, University of Lincoln. His main responsibilities include providing regulatory strategy/nonclinical support for new product development and registration of small molecule pharmaceuticals, biotechnology products, gene and cell therapy products, vaccines and medical devices. Professor Baldrick has over 35 years of experience in nonclinical development (CRO, UK and Belgium industry) with knowledge of the development of many compound classes and regulatory issues/submissions; along with extensive regulatory agency interaction, he has written numerous peer-reviewed publications (over 75) and is a regular podium speaker/chairperson as well as a lecturer on training courses for a range of nonclinical and associated regulatory topics. He is a Fellow of The British Toxicology Society (FBTS) and a member of the editorial board for various journals.

This webinar is sponsored by Fortrea.

Disclaimer: Whilst TOPRA is running this webinar for Fortrea, this is not an endorsement of Fortrea, Fortrea's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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