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Featured Articles

May 2011

Marie McKenzie Mills

Is There a Legal Requirement to Have SOPs for GCP in Europe?

by Dr. Marie McKenzie Mills
MICR, CSci, CBiol, MSB

Before addressing whether there's a European requirement for Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP), we need to consider whether ICH GCP (i.e. as provided by the International Conference on Harmonisation) remains the international standard following the publication of the Clinical Trials Directive (2001/20/EC) and the GCP Directive (2005/28/EC). Why? Mainly because the Clinical Trials Directive did not explicitly mention ICH GCP, leading to the perennial question of: which GCP should we be following? So here goes my answer, particularly for those of us affected by European legislation, with a wee bit of context to explain it.

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John A. Challenger

Certification and Advanced Degrees: Are They Worth It?

by John A. Challenger
CEO, Challenger, Gray & Christmas, Inc.

The value of certification and/or advanced degrees, such as an MBA, often comes into question in the wake of economic downturns. There are two camps on the issue. On the one side you have those who spent time and money earning these achievements and now may be questioning the value of these achievements in light of job loss or, at least, job insecurity. The other camp consists of those who don't have advanced education and wonder if obtaining it would help their job search efforts or career aspirations.

Unfortunately, there is no clear, black and white answer. There are many complex factors. The need for such credentials depends on the job, the company, the interviewer or person screening the resumes, etc. In the end, it probably comes down to this: having certifications and advanced degrees certainly will not hurt your chances of finding a job or advancing in your profession. However, those who believe that certification or an advanced degree is the key to finding employment in a competitive job market will be sorely disappointed.

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Did you know that the FDA is considering a "Super Office" of Drug Safety? FDA is in the early stages of searching for a new head of a "super office" of drug safety within the Center for Drug Evaluation & Research. At the moment, it's unclear whether the position will oversee a newly constituted drug safety office or the agency is attempting to fill the Associate Director of Safety Policy & Communication position left vacant with the departure of Paul Seligman.
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