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 16 November 2015 | By Zachary Brennan
The European Medicines Agency’s (EMA) Management Board has adopted a framework that seeks to streamline and structure industry-agency communications, as well as to increase transparency around those discussions.
The framework, first announced in early October, comes as the agency has grown in size and scope to the point where its approach to managing interactions with industry have become fragmented. The interactions will cover areas of common interest for the agency and industry stakeholders around human and veterinary medicines, though industry questions on a specific product and/or regulatory procedure will still be handled by the relevant EMA operational departments.
Comments on the framework from the European Commission were overall supportive, according to the management board, and address the framework’s emphasis on transparency and a call for multi-stakeholder dialogue.
Now that the management board has signed off on the framework, according to minutes of its meeting released Monday, EMA will implement an action plan that foresees establishing criteria for classification of industry associations, updating the agency’s stakeholder database and launching a new website that will help with the monitoring and annual reporting to the board on interactions with industry associations.
As far as progress on implementing the EMA policy on the publication of clinical data, the management board meeting noted that progress is being made on five workstreams: data receipt and filing, redaction consultation, publication, presentation and management of the external users.
In addition, three new guidance documents -- on redaction of commercially confidential information (CCI), on anonymization, and on the submission of clinical data for publication -- have been prepared and are almost finalized.
“The guidance on CCI will include information on what is not CCI. Concerning the anonymisation of personal data, the Agency recommendation will be to strive for as much clinical utility of the data whilst ensuring protection of personal data, hence facilitating secondary analysis of the data. Companies will be expected to file an anonymisation report (to be equally published) along with the clinical reports,” according to the minutes.
The management board also discussed the development of the clinical trial portal and database, which will allow a number of stakeholders to complete a wide range of processes on the same system.
An agreement with Member States on timelines will be sought in October and November and the current timeline “foresees the auditable release to be available in Q3 2016, the audit to be carried out November 2016 to February 2017 in order to submit the audit result to the board at the March 2017 meeting.”
Minutes of the 89th Meeting of the Management Board
Tags: EMA, industry interactions, EMA Management Board, EC, CCI, trial transparency
Regulatory Focus newsletters
All the biggest regulatory news and happenings.