Welcome to our Boost Seminar!
On the 23rd January 2019 we invite you and your colleagues in the development & regulatory departments to a complimentary seminar on how to fully leverage on oral explanations and other opportunities to convince EU regulators.
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 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.
- 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
Date: 23 January 2019
Time: 9:00 – 12:00
Venue: Medicon Valley Alliance, Arne Jacobsens Alle 15 , 2300 Ørestad City, Copenhagen, Denmark, Ground floor
Registration and Breakfast
Welcome and introduction
Katja Gustafsson, Senior Consultant NDA Regulatory Group
Session 1: Interactions with industry from the perspective of a former agency expert
Session 2: Interactions with agencies from a Sponsor perspective
Questions & Answers
Questions can also be sent in advance to firstname.lastname@example.org.
Please specify if you would like to ask them openly during the seminar or prefer to discuss them privately afterwards.
12:00 – 14:00
Meet and ask the Experts
About the speakers
Professor Steffen Thirstrup
Steffen is a NDA expert in clinical development and regulatory strategies.
Dr Rosalind Cox
Dr. Cox has held senior positions in European and International Regulatory Affairs within the pharmaceutical industry (Abbott, GSK, UCB & Medeva) for 24 years, followed by 8 years at NDA. She is experienced in MAA submissions and other EU procedures such as Scientific Advice (national and EMA), PIP, ODD.
Roz specialises in European Regulatory strategy within the context of global development, particularly for development products.
About NDA Group
NDA Group is a world leading drug development consultancy. Over the past five years NDA has supported over 40% of the new medicinal products approved in Europe.
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