Healthtech Finland is happy to announce the first webinar of the autumn season as we welcome PhD. Ritu Nalubola, Director of FDA Europe Office and M.S. Claudia Louati, Policy Advisor of FDA Europe Office to join us online next Tuesday for a 1-hour session.<\/p>\n\n\n\n
Tuesday 31st August at 2 pm CET (Helsinki +1)<\/p>\n\n\n\n
Join the webinar and learn about the medical device U.S. regulatory framework, IMDRF platform and International activities of FDA in Europe.
Program (2 pm CET, Helsinki +1):<\/p>\n\n\n\n
\u2022 Opening and welcome words
\u2022 Introduction to the FDA Europe Office
\u2022 Overview of the U.S. regulatory framework and steps needed to place a medical device product on the market
\u2022 IMDRF platform and work covering MDSAP\/MDSRP
\u2022 Discussion and Closing<\/p>\n\n\n\n
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\u2019s 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.<\/p>\n\n\n\n
Most recently, Dr. Nalubola has served as the primary lead for FDA\u2019s efforts, working in conjunction with the broader U.S. government, to modernize the federal regulatory system for biotechnology products, and has been the Agency\u2019s voice on this subject in numerous domestic and international forums.
She has led and coordinated FDA\u2019s 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.<\/p>\n\n\n\n
Prior to joining the Office of Policy in 2009, Dr. Nalubola spent 8 years at FDA\u2019s 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.<\/p>\n\n\n\n
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\u2019 and Offices\u2019 strategic engagement with European regulatory counterparts.<\/p>\n\n\n\n
She is closely involved in some of the Europe Office\u2019s 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\u2019s regulatory framework and policies for medical products.<\/p>\n\n\n\n
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\u2019 level in the field of health policy. She holds two Master\u2019s degrees in European studies from the Paris Institute of Political Studies (Sciences Po) and the London School of Economics.<\/p>\n\n\n\n
A link to join the webinar has been sent to all Healthtech Finland members.<\/p>\n\n\n\n
<\/p>\n\n\n\n
Healthtech Finland is happy to announce the first webinar of the autumn season as we welcome PhD. Ritu Nalubola, Director of FDA Europe Office and M.S. Claudia Louati, Policy Advisor of FDA Europe Office to join us online next Tuesday for a 1-hour session. Tuesday 31st August at 2 pm CET (Helsinki +1) Join the […]<\/p>\n","protected":false},"author":16,"featured_media":2307,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"1439,1489,1375,3275,1158,1292","_relevanssi_noindex_reason":"","inline_featured_image":false,"footnotes":""},"categories":[14],"tags":[],"em_industry":[],"em_theme":[58],"class_list":["post-3461","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uutinen","em_theme-kasvu-ja-kansainvalisyys"],"acf":[],"yoast_head":"\n