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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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.
Posted 06 October 2015 | By Zachary Brennan
The European Medicines Agency (EMA) is seeing a sharp rise in demand from drug developers seeking dialogue earlier in the drug development process, particularly for biosimilars and drugs with a new active substance, EMA's management board said Tuesday in an update on the first half of 2015.
Of the marketing authorization applications for drug products containing a new active substance and for biosimilars that were submitted in the first half of 2015, 77% had received scientific advice.
"This demonstrates that EMA’s efforts to encourage medicines developers to seek interaction and dialogue with the agency are paying off," EMA said.
In addition, the number of requests for scientific advice and protocol assistance rose by 6% compared to the same period last year. Among those requests, the number of requests for parallel scientific advice with health technology assessment (HTA) bodies more than tripled, from six in the first half of 2014 to 21 in the first half of 2015.
The parallel procedure enables drug developers to obtain feedback from regulators and HTA bodies at the same time and early in the drug development process.
In addition to EMA's interactions with individual companies, the board also adopted a framework that formalizes and structures how the agency will interact with industry associations. The aim of the framework is also to enhance the understanding of the European Union (EU) medicines regulatory framework and increase transparency of EMA’s engagement with industry and report on these interactions annually.
The framework covers a broad range of industry association types, including industry trade associations, organizations engaged early on in the innovation lifecycle, associations of service providers or professionals supporting the industry and associations with multi-stakeholder membership including industry.
The EMA Board also endorsed the addendum to the functional specifications of the EU portal and database, which are part of the transparency rules of the European Clinical Trial Regulation.
And as far as the timeline for the implementation of the clinical trial portal and database, the board said the plan is to have the system available for an independent audit by the end of the third quarter of 2016. If the portal and database get the go-ahead from the audit, the regulation will come into application by the end of 2017.
EMA Management Board Highlights of October 2015 meeting
Tags: EMA, industry interactions, biosimilars, drug development
Regulatory Focus newsletters
All the biggest regulatory news and happenings.