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Voices of the Board

Dual Background Shapes RAQAB Experience

by: Steve Lynn

am very humbled and honored to serve my fellow PDA members on the Board of Directors and Regulatory and Quality Advisory Board (RAQAB).

A little over four years ago, I left the U.S. FDA to pursue endeavors in the private sector. This decision did not come lightly. I was leaving a great team at the FDA—one dedicated to quality pharmaceuticals and protecting patient health. Once I joined the industry ranks, however, I quickly realized that I went from one great team to another. This new team was also dedicated to the same patient-centric objectives but from a slightly different angle. Quality and patient health/safety were still of paramount importance, but instead of overseeing the pharmaceutical industry as a regulator, I was now on a regulated team dedicated to developing, manufacturing and delivering innovative pharmaceuticals to patients around the globe.

As I adjusted to this new role, I was invited to join RAQAB. I jumped at the opportunity because I wanted to collaborate with other quality and regulatory professionals and help influence issues affecting our entire industry. RAQAB’s mission is to serve the PDA membership by influencing scientific-based regulations and providing interpretation on quality and regulatory issues affecting development, manufacturing and control of healthcare products. This means working with global regulatory bodies, including FDA, EMA, etc.

My experiences as a regulator, coupled with my experiences on the regulated side, serve me well on RAQAB because I can oftentimes see both sides of the equation. For example, I can understand why a regulatory agency may write something a certain way in a guidance versus the way it could be interpreted by industry. This dual-empathetic perspective can help how we in industry comment on a regulatory document or drive an internal PDA initiative on the issue at hand. Additionally, having other professionals and ex-regulators on RAQAB to discuss, debate and determine the best PDA viewpoint on an issue helps me to become a more well-rounded professional and better assist the companies with which I am associated. It is a wonderful symbiotic relationship.

If you are interested in someday joining the ranks of RAQAB, I encourage you to volunteer. RAQAB is always looking for volunteers to help with regulatory comments and key documents such as technical reports, Points to Consider papers, etc. For those of you new to volunteering, contact PDA’s Volunteer Coordinator.

I am proud to share by dual experience with RAQAB. Volunteering with PDA has truly opened doors for me. I encourage you to follow in my footsteps.