The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • RAPS' LatestRAPS' Latest

    Focus on: Linda Bowen

    Linda Bowen has more than 35 years of experience in the pharmaceutical industry, including 25 in regulatory and the last 12 specifically focusing on regulatory policy and intelligence. She has been an active volunteer with RAPS at both the global and local levels, having served on RAPS’ board of directors, as a chapter chair, and as an expert author, presenter and speaker. She is currently the chair of the planning committee for the 2019 Regulatory Convergence . Linda is ...
  • RAPS' LatestRAPS' Latest

    Focus on: Allison Komiyama

    Allison Komiyama began her regulatory career at the US Food and Drug Administration (FDA) as a biologist and reviewer, and served as lead reviewer and consult on 510(k) premarket notifications, investigational device exemption (IDE) applications and premarket approval (PMA) submissions. Her specialty was in biocompatibility requirements for implanted devices. After FDA, Allison worked on the industry side in senior regulatory roles before starting her own consulting firm, ...
  • RAPS' LatestRAPS' Latest

    Focus on: Bill Sietsema

    Bill Sietsema has 35 years of experience in the pharmaceutical industry and is currently vice president of global regulatory affairs at Caladrius Biosciences. He has also held executive-level regulatory positions with Amgen, Kendle International/INC Research and has taught pharmaceutical sciences at the University of Cincinnati, College of Pharmacy as an adjunct professor. He has authored 24 journal articles, four book chapters, 42 presentations and posters and is an inven...
  • RAPS' LatestRAPS' Latest

    Focus on: Minnie Baylor-Henry

    Minnie Baylor-Henry has served two separate stints as one of Johnson & Johnson’s top executives, most recently as worldwide vice president for regulatory affairs for J&J’s medical devices and diagnostics business, overseeing global regulatory strategy for numerous products. She also has been with Deloitte & Touche as a national director for regulatory and capital markets consulting, and with the US Food and Drug Administration (FDA) in roles including national health fraud...
  • RAPS' LatestRAPS' Latest

    Focus on: Jethro Ekuta

    Jethro Ekuta, DVM, RAC, FRAPS, is the senior vice president for regulatory, safety and standards at Horizon Pharma. He has more than 21 years of experience in pharmaceutical research and development, and has served in a number of leadership positions with Johnson & Johnson, Genzyme, Bristol-Myers Squibb and others. He also is an active RAPS volunteer leader, having served in roles including chair of the RAPS Fellows Selection Committee and as a member of the Regulatory Aff...
  • RAPS' LatestRAPS' Latest

    Focus on: Don Boyer

    Don Boyer spent more than 30 years at Health Canada, including serving in several senior management positions, before leaving Canada’s regulator to start his own regulatory consulting firm. Earlier this month, he began his term as chairman of the RAPS board of directors. Don is a leader in the global regulatory community, and has been active not only with RAPS, but also with organizations such as the Global Harmonization Task Force and International Medical Device Regulat...
  • RAPS' LatestRAPS' Latest

    Focus on: Susumu Nozawa

    Susumu Nozawa, RAC (US and EU), FRAPS, is the current chair of RAPS’ board of directors. He has more than 15 years of experience in US and international regulatory affairs and compliance, most recently as director of technical and regulatory policy and corporate regulatory affairs at BD in Franklin Lakes, NJ. He also is an active volunteer leader with RAPS as well as other professional organizations, including AdvaMed and the American Medical Devices and Diagnostics Manuf...
  • RAPS' LatestRAPS' Latest

    A View From the Top: An Interview with CRI President Jennifer Kerr, RAC

    This article is based on an interview with Cook Research Incorporated (CRI) president Jennifer Kerr and covers a wide range of topics from her education, to how she became interested in regulatory, to her experiences in clinical affairs and her responsibilities at CRI. Introduction Jennifer Kerr, president of Cook Research Incorporated (CRI), has had an impressive career and is involved with many aspects of identification, development, testing, and regulatory approval...
  • Feature ArticlesFeature Articles

    The Regulatory Interview: Preparing for Success

    • 11 February 2014
    • By
    The interview is one of the most significant steps of the job search process-understandably, it also can be one of the most stressful. Preparation is key. While resumes, experience, credentials and references are all important in regulatory, the face-to-face interview can be the final determining factor between go and no go. Therefore, it is imperative to make the most of your face-to-face meeting (even if via Skype or videoconferencing) to steer the odds in your favor. ...
  • Hamburg: Compounding, Global Regulatory Issues Top Two Upcoming Areas of Regulatory Focus

    Pharmaceutical compounding and global supply chain issues are the two largest regulatory areas of upcoming focus for the US Food and Drug Administration (FDA), Commissioner Margaret Hamburg said in a 2 March 2013 interview with Yale University's The Politic . Compounding Issues Remain In the wide-ranging interview, Hamburg talked about the issues associated with pharmaceutical compounding and a recent outbreak of meningitis several times. In response to a question re...
  • Hamburg Continues to Call for More Anti-Counterfeiting Authority

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg remains adamant the agency needs more authority to go after counterfeiters . For the third time in as many months, Hamburg has spoken out publicly in an attempt to garner more attention for what she sees as a lack of legal and regulatory "teeth" to address the problem of fake and substandard drugs entering the US' pharmaceutical supply chain. Speaking on Wednesday, 7 June to The Financial Times , Ham...
  • Hamburg: FDA Needs More Anti-counterfeit Authority, International Track and Trace Cooperation

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said the agency needs more authority to deal with counterfeit drug products like the fake Avastin that found its way into the supply chain last month. Speaking with CNN , Hamburg noted the fake Avastin has "focused new attention and concern on counterfeit drugs," which she hopes will make it easier to work with Congress. "They're considering some legislation that would give the FDA stronger authority...