Pharmaceutical Technologist - July 2008 - (Page 16)

The tide of change Pharmaceutical companies need to be more proactive during drug development to improve safety operations, but this is no easy task. Mark Perrott Chris Holmes from WCI Consulting Ltd. I nternal and external forces are pushing drug safety to expand its scope of operations; from postmarketing safety monitoring to a more active stance in the characterization of safety profiles during new drug development. Taking drug safety operations from the reactive approach that currently dominates the industry to a proactive approach will result in greater safety input during drug development. However, this calls for a huge cultural and technological shift. Tightening regulations High-profile drug failures, such as Merck’s Vioxx in September 2004 — the largest prescription drug withdrawal in history — have led to pharmaceutical companies being under greater scrutiny from regulators and the media. All too frequently, companies are being accused of putting profits before patient safety, and the increasing number of stories regarding drug safety in the mass media has heightened public anxiety. This media focus on risk has resulted in a push from legislators and regulators to ensure that pharmaceutical companies put more effort into managing risks and, so far, there is no priority given to educating users about the inherent benefit/risk balance of medicines. In the EU, regulators now require new drug submissions to be accompanied by a formal statement of the need/lack of need for a risk management plan. The necessity for global consistency has resulted in the submission of similar documentation whenever a drug is to be launched. In FDA’s Amendment Act of 2007,1 which was recently passed by the House of Representatives, there are clauses that describe the requirements for publication of both development and postmarketing clinical trial results. This legislation highlights the 16 JULY 2008 PHARMACEUTICAL TECHNOLOGIST Paul Edmondson/Getty Images

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Pharmaceutical Technologist - July 2008 Contents Industry Highlights Morpheus Market Watch Overcoming the Barriers The Tide of Change Eight Steps to Improved Water Efficiency Q&A

Pharmaceutical Technologist - July 2008

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