Welcome to NDA’s free Lunch seminar on Tuesday 30th April 12:00- 14:00 on Interactions with Agencies During Drug Development
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.
ABOUT THE SPEAKERS
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.
- 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
When: Tuesday 30th April 2019
Time: 12:00 – 14:00 (opportunity to book 1-1 meeting afterwards)
Venue: Queen Edith’s Room, The Cambridge Building, Babraham Research Campus, Cambridge, UK
The lunch seminar will be an open and interactive workshop with the opportunity to ask our presenters questions.
Specific questions can also be sent in advance to firstname.lastname@example.org. Indicate if you would like to discuss them openly during the meeting; otherwise we can book separate meetings to discuss them after the seminar.
Registration: RSVP by Friday 26th April 2019 to email@example.com.
Contact: Anna Perrin, Marketing Assistant, +44 (0) 1372 860 623, or email firstname.lastname@example.org.
The lunch seminar is free. If you are unable to attend, please advise us no later than two days before the seminar.
We look forward to seeing you there!