Pharmacovigilance

Pharmacovigilance: Center of Excellence

Pharmacovigilance (abbreviated PV or PhV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.

Generally speaking, Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, Herbalism and traditional medicines with a view to:

• Identifying new information about hazards associated with medicines
• Preventing harm to patients.
• New global regulations have forced the concept of Pharmacovigilance to expand beyond just identifying adverse events. Today Pharmacovigilance is on the minds of every pharma and bio executive, and it starts earlier in the drug development process.

Our Center of Excellence provides Insight and Information on the evolving trends in Pharmacovigilance:

• A key change in thinking for those working in Pharmacovigilance is the realization that the benefit-risk assessment is the ultimate driver for patient safety and not simply the frequency of adverse event types. The initial risk/benefit assessment at the time of marketing application is made with limited information and is based on a relatively homogeneous population, often based on restrictive entry criteria dictated by the inclusion/exclusion criteria of the phase I to III studies in the clinical development program. As a consequence of this greater awareness, improvements have been made in the gathering, reviewing, and reporting of patient safety information.
• Risk evaluation and mitigation strategies (REMS) and risk management programs (RMPs) are the leading topics in today’s evolving industry. Consequently, pharmaceutical companies are increasingly adopting signal management solutions to help them support their risk management activities. There is also a shift from “post-market” surveillance to full-spectrum monitoring of a drug. Pharma can and must monitor safety throughout a drug’s entire life cycle — from clinical development all the way through patient care.
• There is a growing trend toward incorporating more Pharmacovigilance activities into biopharmaceutical product development. Historically, assessment of safety and efficacy occurred during the marketed life of a biopharmaceutical, and now there is a new shift toward conducting ongoing risk/benefit analysis over the entire product life cycle, including from first-in-human studies through the product’s end of life in the market. Another trend is to collect a larger amount of data in order to identify patterns of safety-related issues. This trend for more data collection along with regulations that require the implementation of risk management plans at the time of submission is indicative of a new level of effectiveness in proactively managing compounds in development.
• An increased emphasis on collecting and examining safety in a manner that is more directly aligned to the long-term value of the drug commercially, beginning with early phase clinical trials and continuing into post-approval phase. Sponsors who maximize their knowledge of their drug’s pharmacovigilance profile and integrate it into their commercial planning will have greater influence with regulators, payers, and ultimately patients and prescribers.