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17 May 2012
By Zachary Brousseau
Every drug comes with some risk. The key issue for regulators, drugmakers, healthcare professionals and patients alike is whether the likely benefit is greater than the risk. This is the question [
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14 May 2012
By Zachary Brousseau
The Regulatory Affairs Professionals Society (RAPS) will host its next Virtual Career Fair on Thursday, 17 May, from 10 am–6 pm EDT. RAPS members can enter the fair at 9 am—one hour ahead of the [
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26 April 2012
By Joy Frestedt, PhD
Nominations are now open for RAPS awards, which go to regulatory professionals with diverse, global backgrounds.The RAPS Awards Committee is currently seeking nominations for RAPS’ annual awards [
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25 April 2012
By William C. Putnam, PhD, RAC
You are the senior regulatory professional in the board room overseeing a major development program. The program looks promising and all you need to be concerned about is the most [
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25 April 2012
By Zachary Brousseau
The Regulatory Affairs Certification Board and the Regulatory Affairs Professionals Society extend sincere congratulations to the 279 individuals who earned their Regulatory Affairs Certification [
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3 April 2012
By Zachary Brousseau
The electronic Common Technical Document (eCTD) is designed to make regulatory submissions easier and more efficient—for drugmakers and for regulators. It provides a common global standard for companies to electronically submit the quality, safety and efficacy information required for approval of a new drug to regulatory agencies in the US, EU, Canada and Japan. [
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30 March 2012
By Zachary Brousseau
Pharmacist and seasoned regulatory professional Max Sherman has written on science and medical topics for years, and began writing for RAPS’ magazine
Regulatory Affairs Focus, as it was called at the time, more than a decade ago. Over the years, his writing has covered a range of diverse and occasionally unusual subjects related to the practice of medicine, medical research, regulatory issues, biology, chemistry and other related disciplines.
He has taught university-level classes on quality and regulatory affairs, and his writing is often educational, whether it’s a history lesson about quack medical devices, a biology lesson about bats or a peek into processes of the US Food and Drug Administration (FDA), it’s almost impossible not to learn something new reading one of Sherman’s articles. At the same time, he writes in an accessible and entertaining style.
RAPS has now published a collection of Sherman’s articles from
Regulatory Focus and other publications, entitled
From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories. I recently had a chance to talk with him about the book and his writing. Following is an edited transcript of our conversation. [
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27 March 2012
By Jethro Ekuta, DVM, PhD, RAC, FRAPS
History was made when the inaugural class of RAPS Fellows was honored at the 2008 RAPS Annual Conference in Boston. I was fortunate to have been selected as a member of that class. I have served as a member of the RAPS Fellows Selection Committee every year since, and currently serve as the vice chair.
Many colleagues have inquired about how they can become Fellows, but they end up not completing an application. The reasons are varied—too busy, lack of knowledge of the qualifications and requirements, an erroneous perception that the application process is daunting, or simply procrastination.
Whatever reason may have kept you from applying to become a Fellow, this article describes
the Fellows program, including the application process and evaluation criteria, so you can be equipped with the information you need to make an initial self-assessment and complete a high-quality application. [
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22 February 2012
RAPS recently fielded the 2012 iteration of its ongoing research initiative on the regulatory profession, the
RAPS Global Scope of Practice & Compensation Survey. This research has been conducted by RAPS for more than 20 years, and it continues to be the largest, most comprehensive study of the healthcare product regulatory profession. RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE, recently spoke with Regulatory Focus about the study and its implications. [
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17 February 2012
By Nancy R. Katz, PhD
One option for a career in regulatory affairs is becoming a regulatory writer in the biopharmaceutical industry. This profession is acknowledged as meaningful and challenging, and regulatory writers are recognized as vital to the industry. Regulatory writers are employed in biotechnology, pharmaceutical and medical device companies, as well as contract research organizations (CROs), and can be full‑time staff members or consultants to all of the above. This chapter describes the work of a regulatory writer in the field of drug research. It explains the fundamental knowledge required to perform the work and the specialized knowledge needed for success. Its focus is on submission of drug applications in the US. [
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