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Congress Center Basel

2018年4月16日 (月) 午後 2:00 - 2018年4月16日 (月) 午後 5:30

Messeplatz 21 , CH-4021 Basel , SWITZERLAND

Moving from Risk Management to Benefit-Risk Management – Embedding Pharmacovigilance Principles into the Product Life Cycle


Shelley  Gandhi, MSc

Shelley Gandhi, MSc

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group, United Kingdom

Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented the UK on EMAs EudraVigilance Expert Working Group. Shelley now supports clients with QPPV, Risk Management, Inspection Readiness and implementation of global PV systems.

Bill  Richardson, MD

Bill Richardson, MD

Medical Advisor, NDA Regulatory Science Ltd, United Kingdom

Bill Richardson qualified in medicine in 1980, and subsequently trained as an anaesthetist. He took up his first post in the pharmaceutical industry as a Medical Adviser in 1987. The next 15 years were spent in the industry in Medical Affairs, Clinical Development, and Pharmacovigilance. He joined the Medicines Control Agency (now MHRA) in 2002 and had responsibility for monitoring the safety of “black triangle” products; signal generation and assessment; pharmacovigilance assessment for CHM, PRAC and CHMP; assessment of licence variations; assessment of Periodic Safety Update Reports and Risk Management Plans; and assessment of advertising. He left the MHRA in 2014 to become a pharmacovigilance consultant for NDA Group.