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Monday, February 4 • 14:00 - 17:30
SC02: Short Course 2: European Regulatory Meetings – How to Best Prepare and Perform

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Component Type: Tutorial

High stakes meetings such as CHMP/PRAC oral explanations are often the ultimate chance for a pharmaceutical sponsor to convince EU regulators that the benefit/risk balance of their product is positive. Being well prepared and performing professional is key to success. This short course focuses on how best to plan, manage, prepare and execute successfully at EU high stakes meetings. Former CHMP members, pharma executives and communication specialists will walk you through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with EU regulators. Focus will be on CHMP oral explanation but the learnings will be applicable to all other EU regulatory oral interactions. We will discuss how best to present your key massages and supporting slides and manuscript. How to develop a Q&A grid in collaboration with your team and how best to manage back up slides when responding to questions will be part of the learnings. How best to deal with practicalities and logistics around a CHMP oral explanation in order to minimise the stress on your team will also be touch upon. The course will include anonymized examples from real or imagined meetings and enable the participants to better understand the process and its challenges as well as how best to cope with these.

Who should attend?

Regulatory affairs professionals involved in EU centralised MAAs, pharmacovigilance or scientific advice

Learning Objectives

Plan, manage, prepare and execute successfully at EU high stakes meetings

avatar for Lisa Peluso

Lisa Peluso

Principal Consultant, Strategic Communications, PharmApprove, a Member of the NDA Group
Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Director, NDA Regulatory Advisory Board, NDA Advisory Services Ltd, United Kingdom
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor in pharmacotherapy at the Faculty of Health Sciences... Read More →

Monday February 4, 2019 14:00 - 17:30 CET
  Short Courses, Tutorial
  • Featured Topics Regulatory Science
  • Tags Tutorial