Dual Background Shapes RAQAB Experience
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.