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 20 June 2014 | By Alexander Gaffney, RAC,
In less than a month, pharmaceutical companies operating in the EU will need to begin posting clinical trial results in the European Clinical Trials Database (EudraCT) under a new plan meant to expand the amount of information available to consumers.
Background
The plan was first announced by the European Medicines Agency (EMA) in October 2013, when it said that an update to EudraCT, dubbed EudraCT V9, would enable pharmaceutical companies to post new types of information to the database.
The end goal of the system, EMA said, was to move beyond having just basic trial protocol information in the registry, toward a system capable of providing public access to the results of trials, including those with negative results.
EMA opened the system last year to companies, saying they could voluntarily begin uploading the results of their trials to the system immediately. However, it was only slated to become mandatory in "mid-2014," regulators said at the time.
EudraCT V9 Launch
In an announcement on 19 June 2014, EMA regulators said the system is now ready and its launch date is fast approaching.
The new system will become mandatory as of 21 July 2014, EMA said.
EMA explained:
"This date corresponds to the finalisation of the programming of the database as referred to in a European Commission guideline, in application of the current clinical trials Directive 2001/20/EC and the Paediatric Regulation. Under these frameworks, since the result-related information is fed into the publicly accessible European Union Clinical Trials Register, summary results of clinical trials will become available to the public as sponsors start to comply with their legal obligations."
Requirements
Henceforth, EMA said, all interventional trials ending after 21 July 2014 will need to have their results entered into the EudraCT database within six months (or 12 months for some types of trials).
For trials ending prior to 21 July 2014 (but after 21 July 2013), EMA said sponsors will need to submit the results of those trials within one year. Sponsors have two years to post the results of all trials data for trials which concluded prior to 21 July 2013.
The database will also include information on pediatric trials. That data formerly resided on EMA's website, and not EudraCT's website.
The change comes just days after EMA committed to an even broader policy of clinical trials transparency, which is expected to come into effect in October 2014.
EMA Statement
Tags: EudraCT, Clinical Trials Transparency, Clinical Data Transparency, Clinical Trials Reporting
Regulatory Focus newsletters
All the biggest regulatory news and happenings.