We would love to connect with you during the DIA and discuss how we can support you to optimise your path to market approval.

Working together we can:

  • Accelerate your drug development program to reduce your time to approval
  • Optimise the management of the regulatory process to provide accurate and predictable outcomes
  • Reduce your risks and increase the probability of gaining Market Authorization

Don't miss our  great speakers sharing their knowledge in different forums throughout the conference:


Dr Steffen Thirstrup - NDA Advisory Board Director

Neelu Agrawal - Pharmapprove

Carol Longson - ABPI

Tuesday, March 16th,15:00, Session #S0708: Value Communications and Negotiations – Are You Prepared?

Track 07: Value-Access


Dr Paula Salmikangas –  NDA Advisory Board Director

Professor Beatriz Silva Lima - NDA Advisory Board member

Tuesday, March 16th,16:30, Session #S0303: De-risking regulatory strategy for ATMPs

Track 03: Regulatory Strategy


Dr Paula Salmikangas –  NDA Advisory Board Director

Ilona Reischl  (current CAT Vice-Chair) will be the chair of the session and Paula will be presenting together with Ursula Busse & Margit Jeschke (Novartis) and Karen Walker (Roche)

Wednesday, March 17th,16:30, Session #S0503: Comparability strategy as part of Target Product Profile

Track 05: CMC, Quality, GMP


Dr Brian Edwards - Principal Consultant

Wednesday, March 17th,16:30, Session #S0208: Panel Discussion: Estimated Framework and Safety/Benefit-risk Evaluation in the Context of COVID-19 

Track:02: Clinical Operations


Click here to download the full programme.


To pre-book a meeting with one our team simply
contact us meet-us@ndareg.com

Speakers

Dr Steffen Thirstrup

Advisory Board Director

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Neelu Agrawal

Strategic Communications

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Dr Paula Salmikangas

Advisory Board Director

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Beatriz Silva Lima

Advisory Board Member

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Dr Brian Edwards

Principal Consultant

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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.

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