Scientific and biological discovery is increasing at an ever increasing rate. Pressure from patients and politicians to speed up regulatory systems to get earlier access to promising new medicines has increased. As a result, regulators around the world have adopted initiatives to speed up the regulatory process. It is critical that companies keep pace with the changing regulatory landscape to refine their regulatory strategy and to inform their commercial strategies in taking products to market.

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, addressing the following:

•          Expedited pathways – breakthrough and adaptive pathways
•          Orphan drugs
•          Advanced therapies – gene and cell therapy
•          Payers’ response to the high cost of new medicines

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
•          Advanced Therapy Medicinal Products
•          EU scientific advice
•          Early Access to Medicines Scheme
•          Comparative FDA and EMA strengths and differences.
•          SME status
•          Emerging technology frontiers, such as cell and gene therapies.
•          Offering their (de-identified if preferred) case situation in the pre-session questionnaire.

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. He is currently Director at his own independent consultancy, Pharma Executive Consulting (since Jan 2011) offering strategic advice to the health care and pharmaceutical sector in the area of Health Technology Assessment (HTA) and regulatory affairs. Through his consultancy his main work is as Strategic Advisor at NDA Group AB. Thomas is currently serving on several Advisory Boards and frequently speaks at conferences around the world. He was a board member of CBio Ltd Australia (now Invion Limited) for the year 2011. 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.

About Greengage Regulatory Consultancy

Greengage Regulatory is an independent regulatory consultancy based in Melbourne who can meet pharmaceutical regulatory development and marketing needs in EU, AU and NZ markets.  In addition to over 20 years direct EU regulatory experience, Greengage has a working partnership with NDA Group – an EU-based regulatory and HTA consultancy – through which Greengage has access to a comprehensive range of pre-eminent EU regulatory and HTA experts – such as Thomas presenting here today.”