As a Medical Director at VCLS, Peter’s main responsibilities include: the drafting and critical review of clinical development plans, including gap analysis; drafting and critical review of the clinical parts of briefing documents and presentations for EMA Scientific Advice, national scientific advice, and regulator/health technology assessment bodies parallel consultations; critical review of the clinical parts of the scientific sections of Orphan Drug Designationapplications/maintenance and Paediatric Investigations Plans, and client support for any presubmission or clarification teleconferences and oral explanations; critical review of the Clinical Overview and Clinical Summary for the Common Technical Document; developing responses to clinical questions from regulators following submissions, and supporting clients at related meetings with regulators. He also performs due diligence on clinical packages.

Peter has worked in the pharmaceutical industry for 30 years. Prior to joining VCLS, Peter worked as an independent pharmaceutical physician for 20 years, mostly providing clinical regulatory consultancy services. He was also responsible for writing/reviewing clinical study reports, abstracts, review articles, Investigator’s Brochures, Summaries of Product Characteristics and package leaflets, and facilitating systematic reviews and advisory boards.

Peter has experience in a wide range of therapy areas, with a particular focus on oncology (including haematological malignancies), neurology, gastroenterology, dermatology, endocrinology and metabolic diseases. He also has specific expertise in pharmacokinetics

(including bioequivalence studies), diagnostics, radiopharmaceuticals, surrogate endpoints, adaptive designs, adaptive pathways and epidemiology.

Prior to working as an independent consultant, Peter held various senior positions within the consultancy sector in the industry, both in medical communications and contract research organisations. In the latter, he worked variously in regulatory affairs, clinical pharmacology and clinical operation roles. Previously, Peter worked as a junior doctor in the UK National Health Service, gaining experience particularly in gastroenterology and dermatology.

Peter received a BA degree in Physiological Sciences from Oxford University, and then qualified as a medical doctor (MBBS) from King’s College Hospital in London, before receiving the Diploma of Pharmaceutical Medicine from the UK Royal Colleges of Physicians. He is a member of The Organisation for Professionals in Regulatory Affairs (TOPRA) and of the Faculty of Pharmaceutical Medicine in the UK, and holds a Licence to Practise pharmaceutical medicine under the UK General Medical Council. He is also a former visiting lecturer on clinical regulatory documentation and medical communications for the postgraduate course on pharmaceutical medicine run by the University of Wales.

Peter works in the UK office.

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