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Boost seminar – interactions with the agencies during drug development.

Plats: Ørestad City, Copenhagen, Denmark
Datum: 23 jan > 23. jan 2019

Steffen Thirstrup, formerly Division Head at the Danish Medicines Agency and CHMP member, and Rosalind Cox, formerly Divisional VP with Abbott, 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 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.
Venue: Medicon Valley Alliance, Arne Jacobsens Alle 15 , 2300 Ørestad City, Copenhagen, Denmark, Ground floor

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