The Role of Business Process Outsourcing Firms During Adverse Events and Product Quality Complaints

October 3, 2012
Barry Peters, Vice President of Corporate Quality and Compliance, Telerx
and
Heather D. Ferrence, Director of Corporate Compliance, Telerx

Every pharmaceutical, biotech and device company has faced Adverse Events (AE) and Product Quality Complaints (PQC) daily. Depending on a number of factors, those issued may have been minor or garnered front-page news and endangered the company’s reputation. Nonetheless, as the industry faces increased regulations and competition, many have turned to Business Process Outsourcing (BPO) firms to help them overcome the challenges and problems surrounding AEs and PQCs.
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Minimizing Risk in the Clinical Trials Process

September 10, 2012
Roy Devine

Drug development, of course, is a risky business fraught with potential problems that can derail even the most well-organized campaigns. Companies are rightly fanatical about avoiding mistakes that could kill a development effort eight to 10 years in the making, with $2 billion in funding behind it.
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Prescription Pharmaceutical Companies with Embedded Consumer Healthcare Businesses: Identifying and Managing Risks

August 27, 2012
Jeffrey H. Horowitz and Navin Pant

Pharmaceutical companies are increasingly leveraging their consumer healthcare businesses to  diversify their businesses beyond prescription-only drugs, including pursuing efforts to switch prescription-only drugs to over-the-counter (OTC).  Compliance professionals should recognize that a consumer healthcare business has a very different business model than a pharmaceutical company and therefore faces, in many respects, different compliance risks.  This can lead to a compliance culture at a consumer healthcare company that is not as robust as that at a pharmaceutical company.  Given the more prominent role that consumer healthcare businesses are playing in the pharmaceutical industry, it is worth examining a few of the significant differences between the two types of businesses, and to highlight some of the key areas of risks that can arise in this context and the potential approaches to managing those risks.
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