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25th February 2016 BioWorkshop – Conversation with Thomas Lönngren: EU Market Authorisation, Market Access – and the Need for US Alignment

February 25, 2016 @ 8:00 am - 5:00 pm AEDT

So you’re an Australian biotech company. What do you need to consider when developing your strategy for EU marketing authorisation, market access, and the need for US Alignment?

This exclusive session with Thomas Lönngren will allow participants to draw on his experience as Executive Director of the European Medicines Agency, EMA, 2001-2010, as well as the Deputy Director General of the Swedish Medical Products Agency (MPA) prior to that time. Thomas is currently Director of his own independent Consultancy, for the most part as Strategic Advisor to NDA Group, a European-based global regulatory and health technology assessment (HTA) consultancy.

Part 1:
In the first part of the session, Thomas Lönngren will discuss his personal view on the emerging trends in drug development in EU and US, including the regulators and payers response, drawing on his decades of experience in the pharmaceutical development sector and a current interpretation of the important considerations for strategies in developing effective global Regulatory and HTA development programmes.

Part 2:
The second part of the session will be a dynamic and interactive Q & A workshop tailored to meet the interests of participants with in-depth discussion. Registrants will be invited to submit questions and indicate their cases and specific areas of interest in the lead up to the event to create a customised experience.

Who should attend?

Smaller Australian-based companies considering strategies for entering the global market, especially via the EU, who are interested in the opportunity to discuss their strategy questions in depth with this pre-eminent EU ex-regulator in an intimate group setting.

Preference will be given to companies with interest in:
• EU market entry
• EU scientific advice
• Strategic FDA and EMA strengths and differences.
• Offering their (de-identified if preferred) case situation in the pre-session questionnaire.

Thursday, 25th February
11:30am to 2:00pm – Inclusive of lunch and networking

BioMelbourne Network Board Room
Milton House
25 Flinders Lane
Melbourne, 3000

Dr Thomas Lönngren
Former Executive Director of European Medicine Agency (EMA) – 2001 – 2010

Facilitated by:
Ned Kilpatrick
Greengage Regulatory Consultancy

Members $195.00
Non-members $450
(Prices include GST)


February 25, 2016
8:00 am - 5:00 pm


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