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.

Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.

With 10 years in research and >30 in safety, Margaret is currently the Deputy EU Qualified Person for Pharmacovigilance at MSD Ltd. Activities include input to the EFPIA PV EWG, ICH, MedDRA (pre-ICH), the EMA EudraVigilance Steering Committee and the EWG, plus authoring papers on parasitology and drug safety

Chris Foreman is the Deputy Chief Privacy Officer of the US-based Merck & Co., Inc. He is a lawyer, having spent 20 years in the Company’s Office of General Counsel, before joining the Global Privacy Office in Sept. 2018. Based in Brussels, Chris has practiced law in London, Washington DC, Istanbul, New York, Brussels and Moscow, focusing on pharmacovigilance, pharmaceutical regulations, trademarks and general corporate work.

Noha gained a Ph.D in Pharmaceutics in 1990 from King’s Collage, University of London. She joined Eli Lilly in 1990 as Research Scientist. Among other jobs she worked as Head of Clinical Trial Manufacturing and Supplies, Pharmaceutical Project Management working on programs initiated by Research Centers in EW and Hamburg. Noha became Manager, GPS Quality in 2004 with responsibility for Europe, Asia Pacific and Japan. 2009 she became Senior Director of Quality in Global Patient Safety with responsibility to establish the quality strategies and processes that will support design, execution, and monitoring of risk management plans, including global risk minimization. 2011 she became the head of the EU Pharmacovigilance group located in the UK.