THIS EVENT IS FULLY BOOKED: To be added to the wait list, please call: 03 9667 8181
Outlook for 2017 and beyond: Regulatory and market access developments in Europe and US
In Conversation with Thomas Lönngren
2016 has been a turbulent year in the international political landscape, with uncertainty around what impact Brexit and the change in US presidency will have on the global pharmaceutical and medical technology industry. BioMelbourne Network is proud to host Dr Thomas Lönngren for a conversational workshop to explore regulatory and clinical strategies for market access in the EU and US in the context of the changing global landscape. This workshop will provide an outlook for 2017 on emerging trends and give companies the opportunity to present their case studies and questions in an intimate group setting. Limited places are available and preference will be given to companies developing strategies for global market entry.
Who should attend: Biotech and medtech CEOs, CSOs, Regulatory & Clinical Affairs Managers and Directors and anyone with an interest in regulatory and market access developments in Europe and US.
This exclusive session with Thomas Lönngren will allow participants to draw on his experience as Executive Director of the European Medicines Agency as well as his present role advising pharmaceutical companies globally on regulatory aspects and market access around drug development.
Prior to EMA he was Deputy Director General of the Swedish Medical Products Agency. Thomas is currently Director of his own independent consultancy, for the most part as Strategic Advisor to NDA Group, a European and US based global regulatory and health technology assessment consultancy.
When: Wednesday, 18th January; 11:30am to 2:00pm – Inclusive of lunch and networking
Where: BioMelbourne Network Board Room, Milton House, 25 Flinders Lane, Melbourne, 3000
Speaker: Dr Thomas Lönngren, Former Executive Director of European Medicine Agency (EMA) – 2001 – 2010
Facilitated by: Greengage Regulatory Consultancy
(Prices include GST)
Dr Thomas Lönngren
Former Executive Director of European Medicine Agency (EMA) - 2001 – 2010
Thomas is former Executive Director of the European Medicines Agency, EMA (Jan 01-Dec 10) and previously served with the Swedish Board of Health and Welfare as Director of Operations (1978-93) and later Deputy Director General at the Swedish Medical Products Agency (MPA), Läkemedelsverket (Jan 93 – Dec 00).
Thomas established the EMA from a relatively small-unknown agency in 2001 to a world-renowned regulatory agency in 2010 and was responsible for all of its operations. Stepping down after 10 years of service, he is currently Director of his own independent consultancy, Pharma Executive Consulting.
Through his consultancy his main work is as Strategic Advisor at NDA Group a leading EU and US regulatory and market access Consultancy Company. During the last 3 years his focus have been advising US based biotech companies from NDAs office in Boston Cambridge
Thomas is also serving on several Advisory Boards and frequently speaks at conferences around the world – US, Europe, Japan and Australia.
He was a board member of CiBio (now Invion Limited) in Brisbane for the year 2011, and is currently a Member of the boards Global Kinetics Corporation in Melbourne and Analytica in Brisbane. Globally, he is Advisor to GLG New York, CIRS UK, Scientificmed Sweden, Molecular Warehouse UK, Pictet Asset Management Switzerland and ReNeuron UK.
He is Honorary Member of the Royal Pharmaceutical Society of Great Britain, Honorary Fellow of the Royal College of Physicians, Honorary Doctor of Uppsala University, Sweden and Honorary Doctor of the University of Bath, United Kingdom. Thomas graduated from the Pharmaceutical Faculty in Uppsala in 1976.
In the first part of the session, Thomas Lönngren will discuss his personal view on regulatory and market access in EU and US putting focus on the needs for companies to think globally and integrated with their drug development plans.
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.
About Greengage Regulatory Consultancy
Greengage Regulatory Pty Ltd is a Melbourne-based independent Regulatory Affairs consultancy to the pharmaceutical and biotechnology sectors.
Greengage’s expertise is strategy, planning and management of the registration of medicines and biotechnology products in the EU, Australia and New Zealand, and of all points in the product regulatory development process from discovery through to post-marketing follow-up.
In addition to over 20 years direct EU regulatory experience, Greengage has a working partnership with NDA Group - an EU-US based regulatory and HTA consultancy - through which Greengage has access to a comprehensive range of pre-eminent EU- US regulatory and HTA experts - such as Thomas presenting here today.
Full refund given up to 7 days prior to the event
No refunds within 7 days of the event