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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
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 01 August 2017 | By Zachary Brennan
The European Commission on Tuesday said it will assess the 19 offers from EU cities to host the European Medicines Agency's (EMA) headquarters as it moves from London's Canary Wharf following Britain's decision to leave the EU.
The Commission's assessment will be published online 30 September 2017, then the European Council will have a political discussion based on the assessment at the General Affairs Council (Article 50 format) in October 2017. The vote will consist of successive rounds as needed, with the votes cast by secret ballot and each of the 27 member states having the same number of votes.
A final decision will be taken at the General Affairs Council and announced 20 November 2017. The cities that have applied to host the EMA as of 1 August 2017 are:
The Commission's assessment will be based on six criteria agreed to by the 27 member states, including operationality guarantees (the availability of appropriate offices), location accessibility (which includes the frequency and duration of flight connections), schools for EMA staffers' children (including the availability of multi-lingual schools), access to the labor market and health care for staffers' families, business continuity (to maintain and attract highly qualified staff) and geographical spread.
All the applications discussed the strengths of their various locations, highlighting their proximity to airports, hotels and other major European cities, rapid relocation proposals and varieties of international schools and job opportunities for families. Many of the applications also include statements and comments from the countries' various presidents and prime ministers, including France's Emmanuel Macron, Denmark's Lars Løkke Rasmussen, Sweden's Stefan Löfven and Spain's Mariano Rajoy Brey.
In addition to the release of the applications, EMA said Tuesday that it will temporarily suspend several activities as part of its business continuity plan. Those activities include the development of the European Medicines Web Portal, a new publicly-available online information source on all medicines marketed in the EU; EMA’s contribution to the e-submission project that will allow applicants to electronically submit documents linked to authorization requests for human and veterinary medicines in a secure and efficient way; the development of a transparency roadmap; and participation in the benchmarking of medicines regulatory authorities in the EU as of 2018.
Applications
EMA on Brexit
Procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority in the context of the United Kingdom's withdrawal from the Union
Tags: EMA relocation, EMA headquarters, applications for new EMA headquarters
Regulatory Focus newsletters
All the biggest regulatory news and happenings.