The healthcare industry is evolving in parallel with changing government regulations, making sound regulatory strategy an essential part of success in the marketplace. SEBA has helped fund Meghna Sareen’s (Foster EMBA) attendance at the Regulatory Affairs Professional Society (RAPS) conference – here she shares what she has learned :


The Regulatory Profession and the Changing Business Environment

The Regulatory function is vital in making safe and effective healthcare products available worldwide. The Regulatory professional’s roles and responsibilities often begin in the research and development phases, move into clinical trials and extend through premarket approvals, manufacturing, labeling and advertising, and post-market surveillance. Valuable skills of a regulatory professional include project management and organization, negotiation and communication, and the ability to learn from the experience of others. Regulatory Affairs Professional Society (RAPS), founded in 1976, is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide. I attended the 2012 RAPS Regulatory Convergence conference held at the Washington Convention Center in Seattle from Oct 28-30 this year. At the conference, Meredith Brown-Tuttle, a Regulatory Affairs consultant presented on developing a successful regulatory strategy. In the earlier days, Regulatory was the last box to check before going to market. However, regulatory strategies and issues are now becoming a central element of most business planning. Regulatory strategy can be seen as the adaptations a company makes to move its product from the development state to achieving marketing approval. For pharmaceuticals and medical device companies, it incorporates the drug or device development plan, regulations and/or guidance documents, strategic advice as well as recommendations on implementation. Implementing a strategy allows a company to map its path forward, examine the pitfalls and mitigate any risks, challenges, or issues that the product might face. Regulatory professionals must allow strategy to be dynamic and let it change as the focus of the company changes, the regulatory landscape shifts, serious adverse events occur, competitor information emerges, or new reviewers join the agency.

An apt question to ask now is – Why do some professionals navigate uncertainty and change better than others? This is addressed in the keynote speech at the conference by Professor Morten Hansen, a management professor at the University of California, Berkeley and at INSEAD in Fontainebleau, France who is also co-author of Great by Choice with Jim Collins and author of Collaboration. Professor Hansen talks about the vital role that regulatory plays in building a truly great enterprise in the type of chaotic, uncertain environments healthcare organizations face today. He stresses the need for regulatory leaders to blend creativity with discipline in order to elevate performance. Based on his research with Jim Collins, he outlined the factors that separate the great from the good. Leaders can be charismatic, bold, visionary, or risk takers but what differentiates them from others is a culture of fanatic discipline, empirical creativity and productive paranoia. He used the analogy of bullets and cannonballs to explain that regulatory professionals challenge the status quo by firing a few bullets; tweak models and see if they work i.e. calibrate and get it right; finally, they make a huge commitment of scaling across the organization which is analogous to firing a cannonball.  Professor Hansen also exploded a few myths. The first is: ‘Act fast, fast, fast’. It is not acting fast but the ability to moderate speed depending on individual situation, and spotting threats and opportunities early that will help make progress. The mantra to adopt is ‘Spot early, decide vary, execute quality. Go slow when you can, fast when you must’.  The second myth is: ‘Change or else you will die as an organization.’ The idea really is to prepare a systematic, methodological and consistent plan where only two-three items are tweaked with the goal of combining continuity with change. At the same time, change is not something to fear as change brings possibilities. Professor Hansen ended his talk by saying that as a regulatory professional, one has the chance to be a part of the change. It is a tremendous opportunity. Seize it !

Meghna Sareen, Evening MBA student, Foster School of Business, University of Washington

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