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 27 January 2015 | By Michael Mezher
Happy birthday! Alles gute zum geburtstag! Joyeux anniversaire! – Happy birthday written in the EU’s three working languages, English, German and French.
If the EU’s medicines regulator were a person, it still wouldn't be old enough to purchase alcohol in the US. Even still, the youthful European Medicines Agency (EMA) says it has much to celebrate this week as it enters its third decade of existence.
To commemorate its 20th anniversary this week, EMA posted a new page to its website highlighting the agency’s major accomplishments since it began operations on 26 January 1995. EMA lists its milestones in a timeline that ranges from the first centrally authorized medicine for human use in 1995 to the 2014 enactment of a new clinical trial regulation.
EMA has accomplished a lot in its short history. Since being founded, the agency has recommended 975 human and 188 veterinary medicines. The agency also oversees seven scientific committees and more than 30 working parties that help guide its actions.
Other highlights include advances made in the regulation of products for rare diseases, herbal medicines, pediatric medicines and advanced-therapy products. More recent milestones include the agency’s recommendations for the first gene-therapy product in 2012 and first stem-cell medicine in 2014.
Even as EMA enters into its third decade, it seems more concerned with what lies ahead than behind. The regulator says it plans to meet in March 2015 to discuss the agency's role "At the crossroads of life science research and development, patient care, public health policy and law.
No word yet on whether the meeting will include a birthday cake.
EMA 20th Anniversary
Tags: Anniversary
Regulatory Focus newsletters
All the biggest regulatory news and happenings.