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 28 February 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) announced 28 February that it intends to conduct a pilot evaluation program for a new electronic data standard format to support application reviews.
The new standard, developed by the Clinical Data Interchange Standards Consortium (CDISC), is known as the Standard for Exchange of Nonclinical Data (SEND).
"FDA believes the use of standardized SEND datasets, together with new and better analysis tools, will enhance CBER's review and evaluation of nonclinical data," said FDA in the Federal Register posting.
The pilot study should allow both industry and CBER to determine if the SEND standard assists or hinders the nonclinical study data submission process in investigational new drugs.
FDA notes that a "lack of uniformity in the formats used by sponsors to submit data [and] the inconsistent use of terminology across submissions complicates CBER's efforts to validate, display, and evaluate the data using modern computer-based review and analysis tools."
Read more:
FDA - Electronic Submission of Nonclinical Study Data; Notice of Pilot Project
Tags: Nonclinical, CDISC, SEND, Pilot, electronic, IND, Latest News, data, study
Regulatory Focus newsletters
All the biggest regulatory news and happenings.