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 15 August 2013 | By Janet Aker,
"Not to advance is to go back," says the Chinese proverb. That's one reason regulatory professionals need to continually improve their knowledge base. And, as their careers progress, that knowledge must include the business domain.
Todd E. Chermak, RPh, PhD, divisional vice president, Abbott Nutrition Regulatory Affairs, Abbott Laboratories, Abbott Park, IL, had this to say about expanding regulatory affairs professionals' knowledge to include business functions: "You really need to have a multifaceted view of the business as well as a deep, functional view of the global regulatory landscape in order to maximize your contribution to the organization.
"It's really powerful when individuals can identify and assess unique opportunities through the lens of business and complex global regulations," Chermak said during a recent interview with Regulatory Focus. "Integrating the two perspectives provides insights on how to maximize patient value and navigate the increasing complexity of a dynamic regulatory environment. Understanding both improves the probability of increasing the size of the opportunity as well as the speed of implementation," he said, adding, "The regulatory professional is in a great position to develop the regulatory pathway in a manner that maximizes the benefit to the consumer."
"I think this is a very different dialogue than what I have seen historically," said Chermak, a member of the RAPS board of directors. "It means being part of developing the business strategy including a range of scenarios that ultimately advance patient care, improve treatment outcomes and enhance the consumer experience."
Networks developed by regulatory professionals often create opportunities to advance thinking on a variety of regulatory and business topics, Chermak noted. RAPS membership, for example, is tremendously valuable because it connects the regulatory professional with the larger regulatory community. RAPS creates a learning culture where professionals can benefit from a broader collective body of knowledge including regulators, academics and industry thought leaders around the world. This information, found nowhere else but at RAPS, helps to improve business practices and advance corporate and professional goals.
To take advantage of ideas coming out of these networks, regulatory professionals must be able to "bring that idea forward as an opportunity in a well-thought-out plan that provides value to the patient/consumer and the business," for example by identifying unique partnerships between organizations with complementary products or services, said Chermak.
"I see this as the next evolution of the regulatory professional," Chermak added. While a deep understanding of regulations and shepherding products through the regulatory process will continue to be "core" to the business of regulatory professionals, what is happening now is a "very integrated approach that means we're involved in and leading strategy development for key aspects of the business.
"I think regulatory affairs now is in the best position to redefine itself for the future," Chermak said. "If we develop regulatory professionals to have greater business acumen as a core competency to complement the existing technical and regulatory knowledge, there is no end to the contributions we can make. The only thing stopping us is that we need to complement a deep scientific and technical regulatory understanding with a strong business understanding. Then I think people will look at us very differently. We have an opportunity to create great leaders versus only technical/regulatory experts."
The Regulatory Business track at the 2013 RAPS: The Regulatory Convergence, September 28 through 2 October in Boston, reflects the strong need for business acumen among regulatory professionals. Business-oriented sessions include:
To learn more about becoming a successful regulatory professional with expertise in business-related functions, register online for the 2013 RAPS Convergence event.
Regulatory Focus newsletters
All the biggest regulatory news and happenings.