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    Nicole Mastrell

    Event Manager & PA to CEO
    Email: nm@mva.org
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    Boost Seminar – Interactions with the agencies during drug development

    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.

    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

    Date: 23 January 2019
    Time: 9:00 – 12:00
    Venue: Medicon Valley Alliance, Arne Jacobsens Alle 15 , 2300 Ørestad City, Copenhagen, Denmark, Ground floor

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    Agenda

    09:00

    Registration and Breakfast

    09:30

    Welcome and introduction

    Katja Gustafsson, Senior Consultant NDA Regulatory Group

    09:45

    Session 1: Interactions with industry from the perspective of a former agency expert
    Dr. Steffen Thirstrup, Director, NDA Regulatory Advisory Board, formerly CHMP member and Division Head at the Danish Medicines Agency

    Session 2: Interactions with agencies from a Sponsor perspective
    Dr. Rosalind Cox, Principle Consultant NDA, formerly Divisional VP with Abbott

    11:00

    Questions & Answers
    The boost seminar will be open and interactive with the opportunity to ask questions to Steffen Thirstrup & Rosalind Cox

    Questions can also be sent in advance to denise.stromquist@ndareg.com.

    Please specify if you would like to ask them openly during the seminar or prefer to discuss them privately afterwards.

    11:30

    Lunch

    12:00 – 14:00

    Meet and ask the Experts
    Book a 20 min slot for a chat directly with our experts by contacting denise.stromquist@ndareg.com.

    About the speakers

    Professor Steffen Thirstrup
    Former Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority; Committee for Human Medicinal Products Member; Committee for Advanced Therapies member; Chairman of the Committee for Human Medicinal Products Respiratory Drafting Group and Co-Chair of the European Commission Working Group on Market Access of Biosimilars under the EU Platform on Market Access of Medicines in EU.

    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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