Interactions with the Agencies During Drug Development

NDA would like to invite you to join  Professor Steffen Thirstrup, Director NDA Advisory Board, formerly Division Head at the Danish Medicines Agency and CHMP member and Dr Rosalind Cox, Principal consultant NDA UK, formerly Divisional VP with Abbot, share their experiences and provide their insights into making the most of the opportunities to interact with EU Agencies during the drug development process.

There are many opportunities for bringing your message across to regulators by interacting with the right EU Agencies at the right time, depending 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.

Learning aspects

• Get an overview of the opportunities for interacting with National Regulatory Agencies and EMA throughout development and how to optimise your interactions
• Learn about procedures 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

Professor Steffen Thirstrup
Director NDA Advisory Board, Former Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority, and CHMP member. Steffen is an expert in clinical development and regulatory strategies.

Dr Rosalind Cox
Principal Consultant NDA UK, formerly Divisional VP with Abbot. Roz specialises in European Regulatory Strategy and Global Development.

Date: Tuesday 30th April 2019
Time: 12:00 - 14:00 (opportunity to book 1-1 meetings afterwards)
Venue: Queen Edith's Room, The Cambridge Building, Babraham Research Campus, Cambridge