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.


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, Munich, Germany

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!

Speakers

Steffen Thirstrup, MD

Advisory Board Director

Read more

Dr Roz Cox

Principal Consultant

Read more

Stay up to date

Contact us

Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

Let's Bring Medicines to the World