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 17 December 2015 | By Michael Mezher
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) says it met or exceeded its performance goals for FY2015, according to a new report.
Notably, the FY2015 Report from the Director will be the last under CBER Director Dr. Karen Midthun's leadership. Midthun is set to retire at the end of 2015, ending her 22 year career at FDA.
As in previous years, CBER met or exceeded the performance goals for product reviews established by the various User Fee Acts:
2 regulatory science projects awarded Ebola supplemental funding
2 regulatory science projects awarded challenge grant funding
CBER also had a relatively busy year for reviews, in FY2015 the center approved 13 new biological license applications (BLAs), four of which were new vaccines.
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
The report also emphasizes CBER's role in the response to the Ebola outbreak in West Africa.
During the reporting period, CBER says it mobilized its experts on the Vaccines and Related Biological Products Advisory Committee and organized a workshop with other government agencies intended to "inform future clinical, scientific and regulatory decision-making related to vaccines against Ebola."
Additionally, CBER says it expedited the review of multiple investigational vaccines to treat Ebola, and lent its expertise to sponsors in pre-IND meetings for Ebola vaccine candidates.
On an international scale, CBER said it participated in 14 meetings with other regulatory authorities and provided expert advice at World Health Organization (WHO) consultations in its efforts to combat Ebola.
FDA
Tags: CBER, Center for Biologics Evaluation and Research
Regulatory Focus newsletters
All the biggest regulatory news and happenings.