FPM Conversation: Pharmaceutical Medicine Liability – “Do I Need a Get Out of Jail Free Card”?

Dr Peter Feldschreiber

Peter is dually qualified as a barrister and physician (B.Sc MB.BS LL.B. FFPM, Call 2000 Middle Temple). He specialises in medical and healthcare law including medical products liability, pharmaceutical and medical devices regulatory law, clinical negligence and personal injury and medically related employment litigation. Peter has held appointments as Senior Medical Assessor and Special Litigation Coordinator to the Medicines and Healthcare products Regulatory Agency, Department of Health. In that capacity he was on the secretariat to the Commission on Human Medicines. Peter is also Visiting Senior Lecturer in Pharmaceutical Science at Kings College London. Peter is Treasurer of FPM.

Christopher Bates

Christopher is an associate in the Life Sciences Regulatory team at CMS and advises on a range of regulatory and compliance matters. His experience includes advising pharmaceutical and medical devices businesses throughout the product life-cycle, including clinical research, marketing authorisations, marketing and promotion, pricing and reimbursement and vigilance / post-market surveillance. Christopher has significant experience advising on ABPI Code matters, advising companies both on compliance with the Code and on making and defending complaints under the Code. Christopher has also acted for a number of pharmaceutical companies on significant internal investigations triggered by PMCPA complaints.

David Morgan

David is a solicitor specialising in employment law and has a background in science and the pharmaceutical industry. He has degrees in Microbiology and Biotechnology in addition to graduating from the University of Kent at Canterbury in 2010 with a first class degree in Law. Before retraining as a solicitor he spent more than 10 years as a research scientist in the pharmaceutical industry; working for Pfizer, in their Bioprocess Development Group at Sandwich, Kent where he was involved in the development of microbial fermentation processes. He now advises on all aspects of employment law for Girlings Solicitors.

Paul Knights

Paul is Head Pharmacovigilance Strategy, Policy and Standards at Pfizer, based in UK. Paul is a pharmacologist / toxicologist with over 20 years experience in the industry and has supported pharmaceutical development from early discovery, through non-clinical and clinical development and in the post marketing phase. Paul’s current activities are focussed on regulatory strategy with regards to external changes in legislation ensuring the Pfizer PV system contributes to and adapts to the changing regulatory environment and internal strategy with regards to ensuring Pfizer’s various business development opportunities are appropriately served by the PV system. Paul has previously held the roles of Deputy and EU QPPV and will hold the role of Pfizer’s UK QPPV in 2021.

Craig Hartford

Dr Hartford (moderator) is a Pharmaceutical Physician with special interest in Medicines/Medical-Devices Benefit-Risk Management & Pharmacovigilance. He graduated MBBCh, MScMed, PhD and held full-time academic/research posts until 1998. He then joined Pfizer R&D and in 2010-2019 was Vice President in Drug Safety at Pfizer, overseeing Safety Signal Detection/Evaluation and Benefit-Risk Management for 700+ products across the product drug lifecycle. In 2021 he joined GSK as VP, Head of Specialty Clinical Safety and Pharmacovigilance in Global Safety. He is MFPM(Dis), a FPM Appraiser and a committee member for our Policy and Communications Group and member of our Government and Healthcare Policy Expert Group. He holds a GMC License to Practise Pharmaceutical Medicine.