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.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 28 April 2017 | By Zachary Brennan
With a meeting yesterday between the European Medicines Agency's (EMA) Management Board and heads of the National Competent Authorities of the EU/EEA member states, a discussion was initiated on how to share the work of evaluating and monitoring medicines without the UK's help.
"Although negotiations on the terms of the UK's departure have not yet officially commenced and one cannot prejudge their outcome, work will now start on the basis of the scenario that foresees that the UK will no longer participate in the work of EMA and the European medicines regulatory system as of 30 March 2019," EMA said on Friday.
The agency noted that some general principles for workload distribution will include: ensuring continuity; maintaining the quality and robustness of scientific assessments; continuing to comply with legal timelines; ensuring knowledge retention, either by building on existing knowledge, or through knowledge transfer.
"The envisaged working methodology will include a mapping of current and future capacity and expertise in the network and the identification of potential gaps. This could help the network to increase its capacity in selected areas, and would be supported with enhanced training opportunities," the agency added.
Member state representatives will determine where the agency's headquarters move and EMA said it welcomes the interest expressed by some member states in hosting the agency in future.
"EMA is confident that the member states will make the most appropriate decision on the agency's location and arrangements, taking the complex political and legal environment generated by the outcome of the UK referendum into account," the agency said.
Statement
Tags: Brexit, EMA headquarters, EMA move
Regulatory Focus newsletters
All the biggest regulatory news and happenings.