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 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.
Resources, news and special offers to support you and your professional development during this difficult time.
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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray together.
Updated by a group of distinguished regulatory experts, this new edition is a must-have handbook for regulatory professionals at all levels.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
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.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 08 June 2018 | By Michael Mezher
During the 100th meeting of the European Medicines Agency's (EMA) management board this week, the agency provided updates on its preparations for Brexit and said that the EU clinical trial portal is "nearing completion."
At the meeting EMA announced that it and the Netherlands have signed the agreement detailing the legal relationship between the agency and its staff, and the Dutch government once the agency begins operations in the Netherlands next year.
"The agreement will provide assurance that EMA staff members and their families who need to relocate early to the Netherlands can do so under the protection of the Seat Agreement immediately," EMA said.
The agency also said it has redistributed the 370 centrally authorized products with UK rapporteurs to new co-rapporteurs from other EU countries as well as Iceland and Norway.
According to EMA, marketing authorisation holders were notified of the new rapporteurships in April and the new co-rapporteurs will assume full responsibility for the reallocated products on 30 March 2019, when the UK officially exits the EU.
The agency is also working on a "knowledge transfer package" for each reallocated product that will include background information on the regulatory and evaluation history of each product.
The packages are intended to help national regulators allocate resources for the new products added to their portfolios, especially for more complex products.
EMA also told its management board that an auditable release of its EU clinical trial portal and database is nearly complete.
"Development of the auditable release of the portal and database is nearing completion. The release is now in an intensive phase of testing," the agency said.
In June 2017, EMA delayed application of the EU Clinical Trail Regulation from October 2018 to 2019 due to technical difficulties with the development of the IT systems necessary to implement the regulation, which include an auditable portal and database for all clinical trials in the EU.
Looking ahead, EMA said it will begin user acceptance testing of the release in November after the relocated data center is completed, and is planning to audit the system in early 2019.
EMA also said it is paying close attention to how its relocation may impact the completion of the clinical trial portal, especially in the event key agency or developer staff choose not to relocate.
EMA
Regulatory Focus newsletters
All the biggest regulatory news and happenings.