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 14 October 2016 | By Edward Tabor, MD,
The following is an insightful review of a compilation of essays featuring new, somewhat obscure information about science, regulatory and healthcare products.
There can be no more delightful way to learn a few extra regulatory concepts than by reading a book written by Max Sherman. Eclectic Science and Regulatory Compliance: Stories for the Curious is Sherman's second book of essays on regulatory science. A few years ago, when I read his earlier volume of essays, I kept thinking, "I hope Max Sherman writes more of these," and now he has done so.
Each essay is fascinating; many of them start with a medical discovery and interpret the regulatory implications. For instance, an essay on the experimental use of fecal transplantation to treat pseudomembranous colitis provides a discussion of the issues FDA has had to address in order to regulate this bizarre therapy under an IND. Another essay on the drugs and devices used to treat George Washington's terminal illness makes one glad that FDA keeps such products off the market in the 21st century.
Many essays discuss recent medical discoveries that have captured Sherman's interest. Some discuss only regulatory topics, such as essays on the use of mathematics in regulatory science, quality control from an industry perspective, and the responsibility of regulatory professionals to get involved in teaching regulatory science.
The scientific topics clearly reflect Sherman's fascination, and he transmits this to the reader. He often writes, "I was amazed to find …" It is clear that he knows that we the readers also will be amazed and surprised. One example is his essay on the possible use of the python as an animal model for studying cardiac drugs – an ideal animal model in that it only needs to be fed twice a year and might provide a model to study hyperlipidemia. After a python swallows a large mammal (using its expandable, dislocatable jaw), a python's serum triglyceride levels can rise to 50 times normal, but with no excessive fat deposits in the vessels of the heart. Another article about treating bladder cancer by infusing BCG, a live tuberculosis vaccine, into the bladder, results in the organisms binding to cells on the bladder wall and inducing an immune response against the tumor cells. Sherman tells us that this was suggested as long ago as 1929 as a result of the observation that tuberculosis patients don't get cancer as often as healthy individuals do.
Some of the essays cover really new concepts in thinking. One of these examines "bioinspiration" the process of looking at functions of structures in plants or lower animals to find new principles for devices to meet human needs. Another examines the use of "mindfulness training" to reduce the occurrence of human errors, i.e. teaching the art of paying attention to avoid making mistakes in the hospital or in any of our human mental or physical tasks.
This is a great book for regulatory professionals who are interested in the intersection of regulation and science. It would also make a great gift to give to colleagues on special occasions.
Eclectic Science and Regulatory Compliance: Stories for the Curious contains 36 short, well-written articles packed with interesting facts. Topics include: the animal kingdom, pythons, ticks, octopuses and giraffes; the human senses of smell, vision and touch; featuring famed scientists as John Snow, Joseph Lister and Lewis Thomas. For more than a decade, Regulatory Focus readers have enjoyed Max Sherman's search for new and surprising facts. There are some "ah ha" moments and some laughs, as well. Unlike most RAPS publications, Eclectic Science is light reading and of interest to both scientists and the general population. This is a follow-up to Sherman's first book, From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories, published in 2012.
Regulatory Focus newsletters
All the biggest regulatory news and happenings.