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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
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 15 November 2016 | By Zachary Brennan
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday announced the launch of the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program, which is meant to help OPQ staff learn more about industry’s drug development and manufacturing processes.
The program, which aims to bring groups of OPQ staff to observe operations of commercial manufacturing, pilot plants and pharmaceutical testing over a one- to two-day period, is designed to offer firsthand learning opportunities to improve staffers’ understanding of the pharmaceutical industry and its operations, as well as of the challenges that impact drug development.
OPQ has identified a number of areas of particular interest to its staff, including:
Selection of potential facilities for the program will be based on these priorities, FDA says, as well as the facility’s current regulatory status with FDA, and based on consultation with FDA district offices.
All travel expenses associated with this program will be the responsibility of OPQ, so selection of the sites that can participate will be based on the availability of funds and resources, and OPQ says it will not provide financial compensation to the sites as part of this program.
The program will allow participating sites to benefit by having an opportunity to showcase their technologies and manufacturing processes.
Companies interested in offering a site visit or learning more about this site visit program should respond by submitting a proposal to Janet Wilson at CDEROPQSiteVisits@fda.hhs.gov.
Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry
Tags: OPQ inspections, FDA inspection training, CDER inspections
Regulatory Focus newsletters
All the biggest regulatory news and happenings.