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.
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.
Posted 09 November 2017 | By Zachary Brennan
European Medicines Agency (EMA) Executive Director Guido Rasi this week sent a letter of support to the Safer and Faster Evidence-Based Translation (SAFE-T) Consortium and the Predictive Safety Testing Consortium (PSTC) to encourage further study of ways to monitor for drug-induced vascular injury (DIVI) in early clinical drug development.
"Drug-induced vascular injury in nonclinical animal toxicology studies can cause considerable delays in the drug development process and promising candidate drugs are often terminated as the occurrence of DIVI cannot be monitored or substantiated in healthy volunteer or patient trials due to the absence of specific, sensitive biomarkers," Rasi wrote.
The termination of such research has led to a wider search for circulating biomarkers that can detect, in a sensitive and specific manner, the onset, progression and reversibility of DIVI, Rasi said.
"The only currently available biomarkers used to assess the potential for vascular injury in early clinical studies are non‐specific markers of inflammation, markers of immune-mediated drug reactions (for large molecules), and for compounds that are systemically 'vasoactive' in nonclinical studies, heart rate and blood pressure," he wrote. "Having more sensitive and specific DIVI biomarkers would allow drug development teams to manage DIVI as a monitorable nonclinical finding. With these tools a team could safely advance potential new medicines, including both small molecules and large molecules, which cause nonclinical DIVI into clinical studies at safety margins not previously possible without such DIVI biomarkers, thus enabling exploration of clinically efficacious doses."
Rasi's letter, dated 7 November, follows the sending of a similar letter to the same groups by the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research Director Janet Woodcock on 7 November 2016.
Rasi also called for further data sharing and integrating data across trials to foster an accelerated path for biomarker qualification.
Letter of support for drug-induced vascular injury (DIVI) biomarker
Tags: Guido Rasi, DIVI biomarkers
Regulatory Focus newsletters
All the biggest regulatory news and happenings.