As head of the RAPS Bay Area Chapter, Shaalini Doan is eager to welcome RAPS members to San Jose, CA, for the upcoming annual gathering of the global regulatory profession. “The Bay Area is the perfect place to host the 2016 Regulatory Convergence, especially since this year we have the chance to celebrate two significant milestones—the 25th anniversary of our local chapter along with the 40th anniversary of RAPS!”
The Bay Area Chapter is the original local RAPS chapter and continues to be very active. “We have 2,500 members—which also makes us one of the largest chapters in RAPS—and all very enthusiastic, professional and fun,” said Doan.
The chapter was founded in 1991 by Virginia Perry and built on the local regulatory forums that Perry ran with the support of her company. “At first, we met informally just to talk about our issues and try to help each other. We met here and there. But, soon we found we had grown from a gathering of 25 people to a group of more than 250!”
Perry, who led the Bay Area Chapter for its first 10 years, recalled what it was like as a newly minted RAPS chapter. “In the early 1990s, there was a rapidly growing need in the Bay Area to educate and train regulatory professionals, as a direct result of the increased presence of the medical technology firms. There also was a tremendous need to develop relationships with FDA.”
At that time, the regulatory environment was rapidly changing and more stringent requirements were being set by FDA. “When we began our chapter, the most important activities were in the area of compliance. FDA was very rigorous in its enforcement in those days,” Perry recounted. “We needed to educate those in regulatory to understand what the requirements were for the new Quality System Regulations. Design controls were being established, and the chapter was able to join the Pacific Region FDA in the training.”
“We partnered with FDA to develop these trainings—and that was important as it was the beginning of our working relationship with the agency here on the West Coast,” said Perry, who remains an active RAPS member and is president of Perry-D’Amico & Associates, a consulting firm in the Bay Area.
“Today, chapter members may find us online, but just as much by word of mouth,” said Doan. “The Bay Area has lots of start-up, mid-size and large companies where the regulatory function plays a significant role.”
“The West Coast has a tremendous base of industry—pharma, biologics, as well as medical devices. The problem is that we are far away from the East Coast, and it is expensive to travel to conferences and seminars,” said Perry. “Therefore, more RAPS educational programs were offered on the West Coast, making it easier for people to develop their careers.”
Doan explained that chapter members benefit in different ways, depending on their experience levels. “For entry-level members, the local chapter helps build relationships. At mid-level, we help you learn new regulations and requirements. For executives, the RAPS chapter plays a strong role in helping you develop your team,” she said.
“Through the RAPS Bay Area Chapter, I met my mentor, who has helped me with career decisions, questions about regulatory submissions, how to tackle real-time problems,” said chapter member Pooja Shah. “Whether it is a meeting or other session, we share real-time knowledge.”
Chapter member Susan Carino added, “The Bay Area is a very active chapter and our members are very engaged, not only in supporting each other but in learning from each other. That is what makes it so exciting to be a regulatory professional here in the Bay Area.”
Starting with the Bay Area 25 years ago, local RAPS chapters provide city and region-specific opportunities for networking, as well as promoting training and career options. RAPS chapters offer the chance to connect with other regulatory professionals and build career-long relationships.
RAPS helps provide the continued education, skills and connections to address the challenges regulatory professionals face every day. It provides platforms for regulatory professionals to interact with colleagues from regulatory agencies and industry to understand what issues are evolving and how to engage in creating solutions.
RAPS currently facilitates 14 chapters. Most are in North America, but several are in Europe and Asia, as well.
This article is one in a series looking at the development of the regulatory profession and of RAPS during RAPS’ 40-year history. This year marks the organization’s 40th anniversary, which will be celebrated during the Regulatory Convergence, 17–20 September in San Jose. For more information or to register, visit RAPS.org/Convergence.
RAPS and the Regulatory Profession: How Far We Have Com
RAPS and the Regulatory Profession: Elevating Standards Through Education and Certification
RAPS and the Regulatory Profession: The Global Professional Network