Interactions with the Agencies during development

How to fully leverage on oral explanations and other opportunities to convince EU regulators

Welcome to NDA’s free breakfast seminar on 4th December 8:30 – 10:00

There are many opportunities for bringing your message across to regulators, by interacting with the right EU Agencies at the right time, dependent on the type of product, applicant, procedure and stage of development. Find out whether you’re making the most of all these opportunities to facilitate your drug development program.

Join us to hear Steffen Thirstrup & Rosalind Cox share their experiences and provide their insights.


About the speakers

Professor Steffen Thirstrup: Former Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority; Committee for Human Medicinal Products Member; Committee for Advanced Therapies member; Chairman of the Committee for Human Medicinal Products Respiratory Drafting Group and Co-Chair of the European Commission Working Group on Market Access of Biosimilars under the EU Platform on Market Access of Medicines in EU. Steffen is a NDA expert in clinical development and regulatory strategies.

 

Dr Rosalind Cox: Dr. Cox has held senior positions in European and International Regulatory Affairs within the pharmaceutical industry for 24 years, followed by 8 years at NDA. She is experienced in MAA submissions and other EU procedures such as Scientific Advice (national and EMA), PIP, ODD. Roz specialises in European Regulatory strategy within the context of global development, particularly for development products.

Key messages:

  • Get an overview of the opportunities for interacting with National Regulatory Agencies and EMA throughout development and how to optimise your interactions
  • Learn about procedure and product type specific interactions with special consideration for SMEs
  • By failing to prepare, you are preparing to fail [Benjamin Franklin] – an oral explanation is your ultimate chance to engage with EU regulators in getting your product approved

When: 4th December 2018 | 09:00 – 10:00 | Breakfast from 08:30am – Q&A afterwards

Where: Am Klopferspitz 19a, 82152 Martinsried/Planegg, BioM Seminarraum

The breakfast seminar will be an open and interactive workshop with the opportunity to ask questions to Roz & Steffen. Questions can also be sent in advance to ndaseminar@ndareg.com

Please specify if you would like to ask them openly during the seminar or prefer to discuss them privately afterwards.


Registration: RSVP by Tuesday 27th November 2018 to ndaseminar@ndareg.com

Contact: Nathalie Brodale-Breinbauer, +49 (0) 89 3585 4036 or email nathalie.brodale-breinbauer@ndareg.com


We look forward to seeing you there!