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 08 April 2014 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) has had no shortage of critics of its regulation of opioid analgesics, including a controversial decision in 2013 to approve Zohydro (hydrocodone bitartrate), a pure hydrocodone product notable for its lack of either acetaminophen or abuse-deterrent qualities.
But after facing withering criticism and mounting pressure from legislators and even state regulators, FDA is moving to try to establish a constructive dialogue on how it can better prevent misuse and abuse of opioid analgesics through the use of innovative packaging technologies.
In an 8 April 2014 Federal Register posting, FDA said it wants public input on how the packaging used to deliver drugs might be used as part of a broader abuse deterrence strategy.
The problem, as FDA explains, isn't just people trying to abuse an opioid, such as those who crush or inject the pills in pursuit of an ill-advised "high." People using a drug legitimately and for prescribed purposes are just as big a problem.
Those people also run the risk of misuse and addiction, FDA notes. How can those patients be helped?
FDA says it has some ideas, but is also looking for public input.
Key to FDA's envisioned approach is the use of technology and electronic monitoring systems.
"For example, these systems may include functionality to remind patients to take a dose, track when a dose is taken and how much is taken, and limit further access until it is time for the next dose," FDA muses in its Federal Register notice. "Additionally, many of these drug-device combinations electronically encrypt and capture the accumulated adherence data, which can be downloaded directly from the device or wirelessly transmitted to the prescriber. These technologies have not only been used in clinical management and monitoring of protocol compliance in clinical trials, but have also been applied to combat the problem of prescription opioid misuse and abuse."
FDA also highlighted the potential of "track and trace" technologies, RFID-equipped ID-based systems, microchips embedded within tablets, and in-home medication deactivation and disposal systems.
"Many of the features of medication adherence monitoring technologies could be used or adapted to help prevent serious complications (e.g., overdose, addiction) by supporting proper dosage and administration, and could also help prescribers monitor for signs of abuse or medication sharing by facilitating effective patient management and followup," FDA hypothesized.
Technologies might also aid in preventing access or facilitating disposal of medications, such as by chemical deactivation, FDA said.
The agency has established a docket within the Federal Register (FDA-2014-N-0233) to receive comments, which it said should be focused on proposed (and feasible) packaging, storage and disposal designs. Such designs should "not impair access for patients who have legitimate prescriptions," FDA added.
FDA said it's looking for proposals to include eight details in particular:
Comments are due to FDA by 8 May 2014.
Federal Register notice
Tags: Abuse-Deterrent, Abuse Deterrence, Opioid Analgesics, Docket, Opioid, Latest News
Regulatory Focus newsletters
All the biggest regulatory news and happenings.