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BioBriefing: Medicines in the EU: What you need to know to get to market

April 2, 2019 @ 3:45 pm - 6:00 pm AEDT

International guest speaker, Dr Thomas Lönngren, Strategic Advisor, NDA Group AB and former Executive Director of the European Medicines Agency (EMA) is an expert on best practice for market access and regulatory strategy for biotech companies in the EU.

In this seminar, Thomas will provide attendees with an overview of the current European healthcare market and regulatory pathways to get to market. He will explore recent changes in the regulatory landscape; key developments in health technology assessments; and the essentials of payment and pricing in the EU.

Learn how your company can develop a robust EU strategy to alleviate risk and drive success in the European biotech market.

For a more in-depth look at this topic, you may be interested in participating in Module 5 of our Going Global Program – Pathways to Europe: Regulatory, commercial and market access for medicinal products.

Date: Tuesday 2 April
Time: 3.45 pm registration, presentation & discussion 4.00 pm – 5.00 pm, followed by networking until 6.00 pm
Venue: Davies Collison Cave, 1 Nicholson Street, Melbourne, VIC 3000

BioMelbourne Network Members: $65
Non Members: $130
(Prices include GST.)

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Note: Participants registered for the Going Global program will receive three registrations for this event.

Cancellation policy:
A full refund is given up to 7 days prior to the event.
No refunds within 7 days of the event.

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About our speaker

Dr Thomas Lönngren

Thomas is the former Executive Director of the European Medicines Agency, EMA (Jan 01-Dec 10). He previously served with the Swedish Medical Products Agency (MPA) as Director of Operations (1978-93) and Deputy Director General, (Jan 93 – Dec 00). Thomas established the EMA from a small unknown agency in 2001 to a world-renowned regulatory agency in 2011 and was responsible for all of its operations.

He is currently Director of his own independent consultancy company PharmaExec Consulting AB, Sweden giving strategic advice to the healthcare, pharmaceutical/Biotech and medical device industry in the areas of Drug Development, Regulatory Affairs and Market Access. Through his consultancy his main work is for the NDA Group where he has for the past 4 years been active in Cambridge, Boston US advising biotech companies on getting regulatory approval and market access in EU and he is frequently invited to speak at conferences around the world.

Currently he is a board member of Global Kinetics Corporation in Melbourne Australia, Analytica in Brisbane Australia, and Compass Pathways London, UK. He is a faculty member of Gerson Lehrman Institute (GLG), The Centre for Innovation in Regulatory Science (CIRS), Scientificmed AB, Sweden, Molecular Warehouse, UK and ReNeuron UK. Thomas is an Honorary Member of the Royal Pharmaceutical Society of Great Britain, Honorary Fellow of the Royal College of Physicians of Great Britain, Honorary Doctor of Uppsala University, Sweden and Honorary Doctor of the University of Bath, United Kingdom.


April 2, 2019
3:45 pm - 6:00 pm
$65 - $130
Event Category:


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