Ensuring Pharmacovigilance Compliance and Robust Oversight at the Affiliate Level

Due to harmonisation of pharmacovigilance regulations and globalisation, the role of an affiliate has shifted to be a dual role – driving commercial growth along with pharmacovigilance management. At the same time pharmacovigilance has become more complex and operations associated with regulatory and pharmacovigilance activities is an unwanted burden to the affiliate.

Join us to explore the challenges associated with managing pharmacovigilance at an affiliate level, potential solutions and explore the benefits of adopting an outsourced model.

Speakers

Sharlene Ahmed, Drug Safety Manager, Pharmacovigilance and Safety Services, ICON

Sharlene Ahmed is a Drug Safety Manager at ICON with over four years of experience in Pharmacovigilance, including the management of global affiliate services for Pharmacovigilance across 75 countries. Ahmed also acts as Subject Matter Expert (SME) in this area, serving as Local Responsible Person for UK and Ireland. During studies at the University of Nottingham in Biochemistry, Ahmed also took part in a pharmacovigilance and medical information internship. Once graduating in 2014, she worked in the Health App and Technology industry before returning to pharmacovigilance in 2015.

Message Presenter

Barry Rice, Director Project Management, Pharmacovigilance and Safety Services, ICON

Barry Rice has over 23 years of clinical research experience (20 years with ICON) and has worked in various Project Management roles including post-marketing. He has worked for over three years in the development of the global Affiliate model solution for Pharmacovigilance. He received his BSc Honors Degree in Pharmacology from the University of Liverpool, holds a Master’s Degree in Biotechnology from the Nottingham Trent University and a Postgraduate Certificate in International Business Management, Smurfit Graduate Business School, University College Dublin.

Message Presenter