Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 30 April 2013 | By Ansis Helmanis,
The US Food and Drug Administration (FDA) announced today that one of its top regulatory officials, Deborah Autor, deputy commissioner for the office of Global Regulatory Operations and Policy (GO), will be leaving the agency shortly to join Mylan Pharmaceuticals.
Autor's departure is at least the third major staff shakeup in recent days. Yesterday, FDA announced the hiring of a new Deputy Commission for Policy, Planning and Legislation, Sally Howard, and a new director of the Office of Executive Programs, Mary Beth Clark.
In a memo sent to all staff on Tuesday, 30 April 2013, Hamburg told staff that Autor will be joining Mylan as Senior Vice President, Strategic Global Quality and Regulatory Policy.
"Deb has demonstrated great leadership, creativity, and passion for public health throughout her FDA career, and we will miss her." FDA Commissioner Margaret Hamburg wrote. "Deb's last day at FDA will be 1 June 2013." Autor has been with FDA for more than 11 years, and currently oversees around 4,400 staff at GO.
In a statement released by Mylan Pharmaceuticals, Autor said she was looking forward to joining the company. "Mylan has been a leading advocate for ensuring one quality standard, both internally and externally, as evidenced by the company's active role in the development and passage of the FDA Safety and Innovation Act, or FDASIA," she said, according to the statement. "I am very excited to be joining an organization whose people demonstrate such extraordinary passion and commitment to quality and access to medicine. I look forward to contributing to Mylan's continued leadership on quality - both from an operational and policy perspective."
Stepping up for Autor in the interim will be John Taylor III, counselor to the commissioner, who will serve as the chief of GO while the agency searches for a permanent replacement.
Read all Breaking News from RegLink
Read all Regulatory Focus stories on Deborah Autor
Dear Colleagues:
It is with mixed emotions that I write to inform you of the upcoming departure of Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy (GO), after 18 years of dedicated federal government service, including 11 years spent here at FDA.
Deb has overseen various critical programs within the Agency including, most recently, the GO Directorate. In that role, Deb has led the implementation of FDA's strategy for addressing the challenges of globalization and import safety, including the paradigm shift that FDA must make to meet the challenges of globalization today and in the future through global coalitions, global data systems, advanced risk analytics, and leveraging of the efforts of public and private third parties. Deb has outlined a strong vision for GO that focuses on being data-driven, strategic, and risk-based, moving towards a stronger global product safety net to advance and protect public health. Prior to assuming the role of Deputy Commissioner, Deb worked in several critical positions within the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER), including for five years as its Director.
Deb is leaving the Agency to take the position of Senior Vice President, Strategic Global Quality and Regulatory Policy at Mylan, Inc. Please join me in wishing Deb all the best as she and her family relocate to the Pittsburgh area and embark on this new endeavor. While I am sad to see Deb go, I am happy that she has found this terrific opportunity. Deb has demonstrated great leadership, creativity, and passion for public health throughout her FDA career, and we will miss her. Deb's last day at FDA will be June 1, 2013.
I am pleased to announce that John M. Taylor, III, currently the Counselor to the Commissioner, has graciously agreed to serve as Acting Deputy Commissioner for Global Regulatory Operations and Policy in the short term starting May 18 as we look for a permanent replacement for Deb.
- Margaret
A. Hamburg, M.D. Commissioner of Food and Drugs
Regulatory Focus newsletters
All the biggest regulatory news and happenings.