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Contingency Planning

In recent years, many popular prescription drugs, over-thecounter products and medical devices have been forced off the market due to safety concerns. When a regulatory agency decides that a medication presents substantial adverse reactions in the general population, the resulting panic among consumers and the recall process itself can become a challenge to effectively manage. Some companies tend to adopt an ‘it won’t happen to us’ mentality when it comes to product recalls, but the reality is that product recalls can happen to any biopharmaceutical and device company and every second counts in the recall process.

The best strategy is a proactive one. Even if a company thinks it can handle the call volume and other tasks associated with a recall, having a contingency plan in place by researching a capable, experienced outsourcing provider who can step in and provide support is strongly recommended.


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Sameer Thapar is Director of Global Safety Surveillance and Pharmacovigilance for Omnicare Clinical Research. He is a Doctor of Pharmacy (PharmD) and is licensed pharmacist with over 12 years of pharmaceutical industry experience. His expertise in the pharmacovigilance arena spans the realm of regulatory adherence of Ethics Committees’ and Regulatory Authorities’ guidelines, leading domestic and international Health Authority inspections, to processing, interpreting and submitting clinical (Phase I-IV) safety reports and post-marketing adverse events.

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