Webinar: Updates from the FDA Europe Office: U.S. Regulatory Framework and International Activities
Tuesday 31st August at 2 pm CET (Helsinki +1)
Program (2 pm CET, Helsinki +1):
- Opening and welcome words
- Introduction to the FDA Europe Office
- Overview of the U.S. regulatory framework and steps needed to place a medical device product on the market
- IMDRF platform and work covering MDSAP/MDSRP
- Discussion and Closing
Ritu Nalubola, PhD.
Director, FDA Europe Office
Ritu Nalubola is the Director of FDA Europe Office. Prior to taking on this role in July 2018, she served as a Senior Policy Advisor in FDA’s Office of Policy in the Office of the Commissioner. She has advised senior leadership at FDA, the Department of Health and Human Services, and other U.S. government agencies on complex and cross-cutting policy issues, including those related to biotechnology, nanotechnology, food safety, nutrition, and trade-related matters.
Most recently, Dr. Nalubola has served as the primary lead for FDA’s efforts, working in conjunction with the broader U.S. government, to modernize the federal regulatory system for biotechnology products, and has been the Agency’s voice on this subject in numerous domestic and international forums.
She has led and coordinated FDA’s nanotechnology regulatory policy activities and played a leadership role in establishing specific regulations to implement the FDA Food Safety and Modernization Act, representing and leading FDA delegations in multilateral standards-setting and scientific dialogues.
Prior to joining the Office of Policy in 2009, Dr. Nalubola spent 8 years at FDA’s Center for Food Safety and Applied Nutrition on a range of nutrition and food safety policy matters. Her post-doctoral work with the Johns Hopkins University and later the U.S. Agency for International Development involved setting up international public health programs. She joined FDA in 2001.
Claudia Louati, M.S.
Policy Advisor, FDA Europe Office
Claudia Louati joined the FDA Europe Office in September 2016. Her responsibilities include providing analysis on EU and U.S. regulatory and policy developments in the field of medical products and facilitating FDA Centers’ and Offices’ strategic engagement with European regulatory counterparts.
She is closely involved in some of the Europe Office’s ongoing projects on regulatory cooperation, including the expansion of the FDA-EU Mutual Recognition Agreement on pharmaceutical GMP inspections to veterinary medicines. She serves as the Europe Office contact point in Brussels for information about the FDA’s regulatory framework and policies for medical products.
Prior to joining the FDA Europe Office, Ms. Louati worked for 4.5 years as a public affairs consultant in Brussels, where she led advocacy campaigns at EU and member states’ level in the field of health policy. She holds two Master’s degrees in European studies from the Paris Institute of Political Studies (Sciences Po) and the London School of Economics.
A link to join the webinar has been sent to all Healthtech Finland members.
For additional information and requests to join the webinar, please contact:
Sandra Liede, Lawyer, Regulatory Affairs, Healthtech Finland, +358 40 700 1658, firstname.lastname@example.org