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.
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.
Posted 13 January 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) announced on 12 January that it is planning to release new regulatory requirements by mid-2012 for electronic submissions of all study data included in New Drug Applications (NDAs), Biologics License Applications (BLAs) and Abbreviated New Drug Applications (ANDAs).
The new regulatory requirements are a result of CDER's Data Standards Program, which is aims to create standards to facilitate rapid access, analysis, storage and reporting of regulatory data.
The new guidances would, respectively, require that all study data be submitted electronically and instruct industry on how to submit study data using existing data standards. FDA noted that the electronic submission requirements have been worked in to the Prescription Drug User Fee Act IV (PDUFA) performance goals.
CDER has also established a set of "draft working processes" that will align with its Data Standards Program that will provide guidance on how CDER will adopt, modify, implement and maintain data standards. The draft is currently being tested internally at CDER.
The Data Standards Program remains under development, and CDER has provided grants to several organizations to assist FDA in developing the standards. Fifty-seven therapeutic areas and numerous non-clinical areas have been identified for data standardization. Non-clinical needs include 'The Animal Rule', toxicology studies, reproductive studies and in vitro assays.
Tags: BLA, DSP, Data Standards Program, ANDA, 2012, Latest News, NDA, guidance
Regulatory Focus newsletters
All the biggest regulatory news and happenings.