Top pharmacovigilance trend in 2017

The Expanding role of pharmacovigilance in rapidly changing regulatory and commercial climates.

An important new industry study from ProductLife Group highlights the ways good-pharmacovigilance-practice (GVP) guidelines, increased globalisation, and heightened business demands have propelled pharmacovigilance up the life sciences agenda and expanded the demands and challenges regulatory teams face.

Implications for safety and quality assurance extend far beyond the boundaries of regulatory affairs by requiring advance cooperation and data sharing between a range of operational functions. A further trend is an emphasis on risk–benefit balance: companies are now expected to consider the benefits of a product in terms of what it means to patients.

Intensifying commercial pressures also have a bearing on the role of pharmacovigilance to the extent that a new type of pharmacovigilance professional is now emerging — one who blends expertise in safety and quality with a rounded understanding of global regulations and requirements as well as business and budget management expertise.

The study highlights

• The effect GVP guidelines are having on the role of pharmacovigilance and its relationship with quality

• The role safety must play in the decision-making process

• Skills gaps and recruitment implications

• Global complexities, including different regions’ changing GVP requirements and the implications for affiliates.

Drawing on the findings, captured through in-depth interviews with key life sciences industry figures, PLG Evolve—ProductLife Group’s thought leadership programme—will present a Webinar detailing the top pharmacovigilance trends for 2017, the effects they’ll have on the expanding role of pharmacovigilance, and the challenges faced by those involved.

Speakers

• Guest presenter Lesley Wise, PhD, is managing director of Wise Pharmacovigilance and Risk Management, a consultant to companies, contract research organisations, and independent research groups. She has more than 15 years of experience in pharmacovigilance both in medicines regulation as head of the risk management and pharmacoepidemiology group at the Medicines and Healthcare products Regulatory Agency and in the pharmaceutical industry, most recently at Takeda Pharmaceuticals. Lesley has a doctorate in statistical genetics/genetic epidemiology. She is an honorary lecturer in pharmacoepidemiology at the London School of Hygiene & Tropical Medicine and an associate editor of Therapeutic Advances in Drug Safety.

• Erick Gaussens, PhD, is chief scientific officer at ProductLife Group. He has deep knowledge of risk management and regulatory requirements in the life sciences industry and brings immeasurable expertise in cognitive science. His extensive R&D experience across several innovative and highly regulated industries gives him unique insight into the impacts of new regulations, new technologies, and the evolution of product life cycle management from both information management and business process perspectives. Erick’s doctorate in mathematics and Docteur d’État are from Université Paris-Dauphine.

• Cheryl Key, MBBS, is head of pharmacovigilance platform services and principal PV medic at ProductLife Group. She has gained more than 16 years of drug safety experience by working at pharmaceutical and biotech companies, for contract research organisations, and for regulatory authorities. Before joining what is now the Medicines and Healthcare products Regulatory Agency, Cheryl spent several years in medical practice. She has a medical degree from Charing Cross and Westminster Medical School.