Instructors
Valerie E. Simmons, MD, FFPM
Senior Medical Fellow, Global Patient Safety, Eli Lilly and Company Ltd, United Kingdom
Dr. Simmons is currently Senior Medical Fellow (formally the EU QPPV) in Global Patient safety for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focused her career drug safety through senior management positions in Glaxo/Glaxo Welcome and Eli Lilly and Co. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Expert Working Group, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management
Alison Turney, PharmD
Sr. Director, Global Patient Safety (GPS) Signal Management Process Owner, Eli Lilly and Company, United States
Alison Turney, PharmD Dr. Turney is a Surveillance Business Process Advisor in Global Patient Safety (GPS) at Eli Lilly and Company. She is responsible for coordination of activities and processes within GPS and between GPS and global and local functions within the company to maintain compliance with regulatory requirements worldwide. Alison has over 15 years of experience in Pharmacovigilance and is responsible for the strategy and development of processes to enable appropriate characterization and communication of the benefit risk balance of products for patients including Post-Marketing Safety Surveillance, the Development Safety Update Report (DSUR) and the Periodic Benefit Risk Evaluation Report (PBRER).
Stephen Knowles, MD, MRCP
Chief Medical Officer, Halozyme Therapeutics, United States
Steve received his MD from the University of Newcastle Upon Tyne, UK and worked in the UK National Health Service for 17 yrs. He joined Halozyme in 2018 as Vice President, Drug Safety & Pharmacovigilance and became Chief Medical Officer in January 2020, with responsibility for Drug Safety, Medical and Regulatory. Prior to this, Steve worked at Eli Lilly for 16 years, 12 years of which was in drug safety in various roles of increasing responsibility involving safety operations and drug safety surveillance