Sunday, June 23 • 1:30pm - 5:00pm
SC33: #33: European Regulatory Meetings: How Best to Prepare and Perform

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

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 include demonstrating intimate knowledge of your data to meet regulator’s concern as well as being able to present this in a crisp and clear manner. To get to this stage takes meticulous preparation of key messages, slides and the actual speech and may additionally include training key opinion leaders and/or patient representatives to speak or respond to questions in your support. Finally, preparing a head of questions and being able to respond clear and unequivocally to these are equally important to increase chances of 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 explanations, 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 minimize the stress on your team will also be touch upon. This short 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. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals in Regulatory and Clinical teams.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Identify the key messages and supporting slides needed to conduct a successful EU regulators meeting;
  • Develop a comprehensive Q&A grid;
  • Develop a strategy and encourage the development of back – up slides when preparing questions.

avatar for Steffen Thirstrup

Steffen Thirstrup

Director, NDA Regulatory Advisory Board, NDA Advisory Services Ltd
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 →
avatar for Lisa Peluso

Lisa Peluso

Principal Consultant, Strategic Communications, PharmApprove, a Member of the NDA Group
Lisa helps development teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals and provided presentation, Q&A and facilitation training to teams in pharma, and biotech, and has helped... Read More →

Sunday June 23, 2019 1:30pm - 5:00pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA