There’s no one correct path into regulatory affairs.  If anything, one of the most common ways to get into regulatory affairs is “by accident.” That’s how Eleanor Panico, director of regulatory affairs at Eisai, describes the beginning of her regulatory affairs journey.  Eleanor joined us at RAPS Convergence 2022 in Phoenix for a chat about the regulatory profession, her path into it and much more. This interview has been lightly edited for clarity.  Why do you thin...

Kristen Ortiz is a regulatory affairs manager at BD, a large medtech company. She joined RAPS at RAPS Convergence 2022 for a chat about her job, her experience connecting with other regulatory affairs professionals, her decision to get her Regulatory Affairs Certification and more.  "I’m evaluating changes to products that come up for various reasons, suppliers, manufacturing, improvements, anything like that, and then developing the next generation and new products ...

Sabina Hoekstra-van den Bosch has been there since the beginning. Hoekstra-van den Bosch, a RAPS Board member and RAPS Euro Convergence 2023 planning committee member, explains the history behind this crucial meeting and traces the evolution of RAPS Euro Convergence from its beginnings as a meeting in Brussels.   "Before Euro Convergence there was the RAPS Europe Meeting, as we called it," she says. "It started very small as a meeting in Brussels, and we were in Br...

With March advancing upon us, I hope your kickoff to 2023 has been happy, productive, and safe.   After two years as vice president, I started my tenure as chair of the Regulatory Affairs Professionals Society Europe Board of Directors at the beginning of the year.   During my term, I will dedicate my efforts to promoting RAPS in general, and the Regulatory Affairs Certification (RAC) in particular, across Europe. European membership grew by 20% in 2022 (on top of ...

Today, the Regulatory Affairs Professionals Society (RAPS) released its Regulatory Competency Framework Addendum: Performance Criteria , which is an extension of the 2021 Regulatory Competency Framework report . A new performance assessment tool accompanies the framework. “Specifically, the addendum provides performance criteria as outlined in the most recent report,” explained Lindsey Summers, MBA, who served as vice chair of the addendum committee. “Regulatory aff...

Since she first got involved with RAPS in the mid-1990s, Kim Young has been a mainstay among our organization’s rapidly growing European membership. In October 2022, Kim joined RAPS as its first full-time European employee. As our Regional Engagement Director in Europe, Kim won’t just be on the ground at RAPS’ European events . She’ll also be around virtually to help chapters, local networking groups and members get the most out of their RAPS memberships — and to ...

RAPS published the names of 104 professionals who earned their Regulatory Affairs Certification (RAC) during the autumn 2022 exam period. Each joins the prestigious group of more than 5,000 professionals around the world who hold at least one RAC credential .  The RAC credentials are the leading certifications for regulatory professionals in the healthcare product sector and the only accredited through the National Commission for Certifying Agencies . Professionals o...

Rockville, MD, USA —The Regulatory Affairs Professionals Society (RAPS) today announced Bill McMoil as its new Executive Director. Bill joined RAPS in 2017 and has served as Interim Executive Director since April 2020. Under his leadership, the organization has weathered the COVID pandemic and successfully grown operationally and financially, despite the challenging global environment.   “A number of very talented applicants were evaluated for the role, and the RAPS...

The Regulatory Affairs Professionals Society (RAPS) is bringing a networking group for regulatory professionals to Portugal, making it the second community for the profession on the Iberian Peninsula. This marks another step in RAPS’ mission to unite the global regulatory community in education, knowledge-sharing and career development. With this expansion, RAPS now boasts 32 chapters and local networking groups spanning six continents. “I’m passionate about this segmen...

The Regulatory Affairs Professionals Society (RAPS) today unveiled its new, more user-friendly community forum site, Regulatory Exchange . The Regulatory Open Forum is the main RAPS’ discussion board and can only be accessed by members.  It’s the same community members have come to rely on, only with a sleeker look. The upgraded community site is complete with a social media-style homepage and improved pages for every RAPS' chapter . A notable change is the new defa...

For regulatory affairs professionals, education never really ends. Tracking new guidance and staying abreast of changing regulations is critical. But some things can’t wait until you have time to take a course or tune in to a webinar. Sometimes you need the answer to a specific question right now . Other times, you just need a place to share achievements or pain points that only other regulatory professionals would understand. That’s where Regulatory Exchange, RAPS’ o...

The Regulatory Affairs Professionals Society (RAPS) is bringing a networking group for regulatory professionals to Spain, and is teaming up with a group of local regulatory professionals to re-engage Ireland’s regulatory professional community. These moves mark another step in RAPS’ mission to unite the global regulatory community in education, knowledge-sharing and career development. With the addition of Spain, RAPS now boasts 31 chapters and local networking groups sp...