Thomas has been with NDA on a consultancy basis since 2011 advising the company’s management and its clients on management and drug development strategies. From 2020 he is also a member of the board of NDA. He applies his skills to a broad range of regulatory and management areas and has successfully helped clients interact with regulatory agencies throughout the stages of development and during regulatory review.
Thomas also has a number of other positions outside NDA as an advisor and non-executive board member in biotech and MedTech companies.
Key Areas Of Expertise
- Extensive expertise in the EU regulatory systems
- More than 20 years of experience in different roles shaping the EU regulatory system including its international relations with the rest of the world and specifically US FDA
- Regulatory strategy
- From early to late development and post-authorization
- Health technology assessment
- Deep understanding of the EU HTA and payers’ landscape
- Management and leadership skill
- 25 years of experience in a leadership position in regulatory agencies
- 10 years of experience in boards of biotech and medtech companies
- Professional presentation skills
- Frequently invited speaker at conferences in EU and US
Thomas was the former Executive Director of the European Medicines Agency. He 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 previously served with the Swedish Medical Products Agency (MPA) as Director of Operations (1978-93) and Deputy Director-General, (Jan 93 – Dec 00).
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.
Dr Thomas Lönngren