Science & Technology

22 May 2013

Singapore’s GDPMDS versus ISO 13485:2003: A Comparative Analysis

By Kenny Peng, RAC, PEng, and Jack Wong

Unlike many countries, where Good Distribution Practices (GDP) are seen as an extension of good manufacturing practices, Singapore’s GDP for Medical Devices (GDPMDS) was developed to address the unique regulatory issues in a country that has a relatively small domestic market, rapid economic growth, a relatively small but targeted manufacturing sector and a proportionally large import/distribution sector. [Read More...]

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14 May 2013

Digital Pharmaceutical Communication in the EU Part 2: Legal Issues

By Anne-Catherine Maillols-Perroy, Yves Th. Tillet

In part two of a three-part series, we look at specific issues associated with the development of collaborative websites with Web 2.0 features in the EU. [Read More...]

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9 May 2013

Good Clinical Practice: Where Ethics and Quality Meet

By Jim Moran, Erika Stevens and Julie Statzel

This article discusses the history and primary principles of Good Clinical Practice (GCP), explaining that is much more than just a single document outlining the standards for clinical research. [Read More...]

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30 April 2013

Mindfulness Training: A Means to Reduce Human Error

By Max Sherman

Minimizing or preventing mistakes is the linchpin of quality. It defines quality control in its strictest sense and is the key to maintaining an effective quality program. This article discusses the causes of human mistakes, mistake proofing and mindfulness training as a means to improve reading ability, working memory and task focus. [Read More...]

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25 April 2013

Regulatory Issues in Digital Pharmaceutical Communications in the EU--Part 1

By Anne-Catherine Maillols-Perroy, Yves Th. Tillet

The use of eHealth systems and services—defined as healthcare practice using the Internet—offers great potential to improve health systems, and will likely become increasingly common. However, before adopting eHealth technology, healthcare stakeholders should carefully consider the risks and identify legal concerns. [Read More...]

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16 April 2013

Internships -- One Pathway to a Regulatory Career

By Kathryn Rangus, RAC, FRAPS and Joyce Williams, RAC, FRAPS

While those wanting to enter the regulatory profession often augment their educational background and previous related experience with regulatory seminars, classes or even certificate or degree programs, the lack of regulatory work experience still is a barrier for many and can significantly delay obtaining a job. Internships can provide valuable experience as well as a path to a regulatory career. [Read More...]

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8 April 2013

Biotechnological Product Roadblocks in Mexico

By Oliver Cox

On 3 December 2012 the Mexican minister of health was replaced by Mercedes Juan López. The result of this change in leadership has yet to be understood. However, it is reasonable to assume that it may have legislative and operational implications for pharmaceutical companies with interests in Mexico. Recent announcements from the Ministry of Health have indicated a drive toward more timely approval of generic and innovative drugs and an alignment of approval processes with international best practices [Read More...]

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2 April 2013

Sound--How Important It is to Hear!

By Max Sherman

The mechanism of hearing loss is a subject with which we aging individuals should be acquainted. This article is a follow up to my previous publication pertaining to the sense of smell, and it very briefly describes the anatomy of the ear; the complicated biomechanics of sound; and the prevalence and causes of hearing loss. [Read More...]

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18 March 2013

Assessing Benefits Versus Risks in Europe--the New Focus in Pharmacovigilance

By Joerg Seebeck & Siegfried Schmitt

Benefit:risk (B:R) assessment is a critical step in the process of approving a drug and in re-assessing an already marketed drug, in the case of newly identified important safety signals. B:R assessment is a holistic process that requires data from different sources to be reviewed to reach a decision on whether a drug’s benefits outweigh its risks. [Read More...]

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13 March 2013

Drug Registration in Brazil: Challenge or Opportunity?

By Michele de Medeiros Rocha, MD

Registering drugs in Brazil has been a promising strategy for companies from developed countries whose pharmaceutical markets, often governed by repayments, already are saturated and in crisis. [Read More...]

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