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Planning for proactive pharmacovigilance

Friday, September 1, 2017

The role of pharmacovigilance is becoming increasingly prominent, with scope to inform product strategy and health economics. A recent industry debate hosted by ProductLife Group saw some interesting tips for clinical operations.

Look beyond the regulatory burden.

Keeping the higher purpose—patient safety—in focus can help with prioritization, as can identifying ways to benefit operationally and commercially from the rich knowledge base you’re building.

Facilitate cross-functional collaboration.

Pharmacovigilance requires input from throughout the organization, including from affiliates, so it’s important to standardize and align business processes.

Apply pharmacovigilance to inform strategic decisions.

The more complete and the more reliable the picture that pharmacovigilance is developing, the greater the value to the business. A clearer view of safety can influence the decision regarding whether a company should proceed with, say, acquisitions based on products’ risk–benefit profile. As a result, pharmacovigilance could, in the future, play a more active role during the due diligence process.

Look to safety as a competitive advantage.

We can expect to see enhanced safety position itself as a competitive differentiator. Clinical teams can play a proactive role here by highlighting a brand’s properties as part of the clinical development plan.

Rethink roles and skills.

As pharmacovigilance’s reach lengthens, companies will consider whether the function has the sufficient business and strategic skills and experience needed to exert greater influence in clinical risk–benefit and health economics decision making and to play a more integral role in R&D.


Guest Contributor Cheryl Key, MBBS, MFPM, is head of practice PV platform services/principal medic at ProductLife Group, with final responsibility for all projects, programmes, and engagements in the platform, as well as for day-to-day management of the platform team.

Cheryl has more than 15 years of drug safety experience in working with pharmaceutical and biotech companies, contract research organizations, and regulatory authorities. She guides her team to improve and optimise ways of working, to achieve high performance levels, to establish continuous improvement in consistent platform processes, and to ensure compliance by all platform staff with legal, regulatory, and quality requirements. Before joining the pharmaceutical industry, Cheryl spent several years in medical practice in hospital and primary care.

This article was reprinted from Volume 24, Issue 09, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>

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