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RAPS Scope of Practice Study: Tracking the Regulatory Profession

Posted 22 February 2012 | By

RAPS recently fielded the 2012 iteration of its ongoing research initiative on the regulatory profession, the RAPS Global Scope of Practice & Compensation Survey. This research has been conducted by RAPS for more than 20 years, and it continues to be the largest, most comprehensive study of the healthcare product regulatory profession. RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE, recently spoke with Regulatory Focus about the study and its implications.

Regulatory Focus (RF): What is the goal of the Scope of Practice Survey? 

RAPS Executive Director Sherry Keramidas (SK): The Scope of Practice Survey gives us a look at the development of the regulatory profession, monitoring trends and changes in what we call the scope of practice: the duties and responsibilities of regulatory professionals. It also gives us a look at their career progression and compensation.

RF: Why is it important?

SK: Like any profession, the regulatory profession must adapt and evolve. This research provides a way of seeing how it has adapted and changed over time, and gives us insight that helps regulatory professionals respond to the changing needs and anticipate what may be coming next. What we learn helps RAPS create and improve professional development initiatives to ensure regulatory professionals have the knowledge and skills to excel in their roles today and tomorrow. It also provides critical information for RAPS to help the world beyond the profession understand what regulatory professionals do and its importance.

RF: What have you learned about the regulatory profession from previous surveys and what do you expect to learn from the current survey?

SK: We have seen a number of important developments over the 20-plus years we have been conducting this research. We have seen increased movement of professionals across product lines-from more pharma-oriented jobs to medical device jobs and vice versa, and we have witnessed increased involvement in combination products. We have seen a trend away from country-specific specialization to more professionals who have multinational or worldwide responsibilities. And we see strong similarities in the scope of practice of professionals around the world, regardless of where they live and work. Today's regulatory professionals have to be more familiar with regulations and requirements for many different global markets and different products. There is still specialization, certainly, but there is an increasing need for regulatory professionals to understand the broader regulatory landscape. Another interesting development has been that regulatory professionals have become more involved in business and strategic decision making. I would expect each of these trends to continue.

RF: What do you think is driving the increasing involvement in business?

SK: The shift toward more business involvement is something we started to see more than 10 years ago. I think the increasing number of regulatory professionals ascending to higher executive levels played a role in companies' and organizations' burgeoning recognition that regulatory expertise can provide valuable insight to drive more-effective organizational strategies. The fact that regulatory professionals were increasingly being called upon to influence business and strategy decisions led RAPS to launch its Executive Development Program in partnership with the Kellogg School of Business at Northwestern University. That is a pretty good example of how this research helped RAPS identify and respond to a growing need within the profession.

RF: What other changes in the profession have you seen, and what do you think is driving them?

SK: Another trend and an important factor, I think, in the business involvement has been regulatory's increasing engagement throughout the product lifecycle. This made regulatory professionals more important players in all aspects of healthcare products-from research and development through postmarketing. Regulatory has a role at every stage, whereas years ago, the emphasis for regulatory professionals was on submissions and compliance. This change aligns with what is going on in the overall the healthcare product sector. In recent years, we have seen industry's focus shift a bit toward more postmarketing activities and keeping existing products on the market.

RF: Have there been any surprising results from past years' surveys?

SK: I don't think we expected to see the business involvement when it first emerged. Other interesting trends we have seen develop include increased engagement in reimbursement and health technology assessment. Issues of regulation and reimbursement are more often being considered in coordination with one another at earlier stages. A viable product needs to be both approvable and reimbursable, and regulatory professionals are increasingly being asked to help bridge the gap between the two areas.

RF: What new questions have been added to the survey this year? What do you hope to glean from these questions?

SK: We have refined the breakdown of where regulatory professionals spend their time based on feedback from those in the field, and we have added some new questions about what brought them into the profession in the first place and what factors help shape their career decisions. For organizations that employ regulatory people, there is a need to find the best way to recruit, develop and retain regulatory professionals. More information will help both professionals and employers better address career development and talent management.

RF: What can the Scope of Practice survey tell us about the importance of the regulatory profession?

SK: The profession continues to evolve closely in step with the overall healthcare product sector, including the pharmaceutical, medical device and biotechnology industries. Translating scientific and technological breakthroughs in these areas into real, accessible patient treatments demands that regulation keeps pace. In many ways, the regulatory profession is on the cutting edge, at the intersection of innovation, regulation and business. There is a growing recognition of the critical role of regulatory professionals, even as work remains to help those outside the profession more fully understand what they do. Regulatory professionals do important work that, as RAPS' tagline says, 'helps make better healthcare products possible.' The Scope of Practice Study helps us tell this important story.

The 2012 RAPS Global Scope of Practice & Compensation Survey is open now, and regulatory professionals can complete it online at www.raps.org/2012globalstudy. All participants may elect to receive a free copy of the final report. Those with the Regulatory Affairs Certification (RAC) credential will receive one recertification credit. The survey takes about 10 minutes to complete and is anonymous and confidential.


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