Journal of Pharmacovigilance

The importance of pharmacovigilance, now and in the future

4^th International Conference and Exhibition on Pharmacovigilance & Clinical Trials

August 10-12, 2015 London, UK

Michelle Perry

Posters-Accepted Abstracts: J Pharmacovigilance

Abstract:

Pharmacovigilance (PV) works towards ensuring the safe use of all medicinal products on the market today in line with an acceptable benefit risk balance for each product. Marketing authorisation is passed when there is sufficient evidence that a medicinal product is; of good quality, effective and safe for the intended purpose. The benefit risk balance must be continuously assessed throughout the products lifespan, taking into account all available information. Recent legislative changes introduced risk minimisation plans, ensuring that PV has a proactive approach to identifying, communicating and managing any potential safety risks. PV has developed considerably over the past 50 years and continues to do so as the range of medicinal products on the market increases. Thalidomide resulted in international efforts to address drug safety in early 1960s. As technology advances, various opportunities arise further to re-evaluate current medicinal products, both on and off the market, improving overall knowledge of mechanisms of action and therefore safety. Even those off the market have the potential to benefit many people if used with caution and awareness of identified and potential adverse effects. Thalidomide is re-emerging for treatment in dermatology, multiple myeloma and other cancers including oral and prostate, highlighting the importance of a continuous attempt to gain a complete understanding and improve drug safety monitoring. Non-steroidal anti-inflammatories have highlighted the challenges and need for on-going monitoring over recent years, with PV monitoring in the UK leading to a change in diclofenac to a prescription only medicine in January 2015.

Biography :

Michelle Perry has completed her MPhil at the age of 25 from the University of Portsmouth in collaboration with the Drug Safety Research Unit, Southampton. She also has a BSc (Hons.) in Applied Pharmacology from Queen Margaret University, Edinburgh and is currently a Pharmacovigilance Associate at Aspen Pharmacare Trading Limited, based in Dublin, Ireland.