Morell David

Background

About Morell David

Morell's background is in clinical toxicology and biochemistry and he worked at the UK MHRA in the area of PV & Risk Management for nearly 20 years. He was a Senior Assessor (Reviewer) and Unit Manager in the MHRA Pharmacovigilance Risk Management Group, where he had responsibility for carrying out risk-benefit reviews and managing a multi-disciplinary team of medical and scientific staffs. He was also responsible for monitoring, evaluating and reviewing safety data for medicinal products which fell within several therapeutic areas, including oncology, haematology, rheumatology, inborn errors of metabolism, ophthalmology and urology. Morell has hands-on experience of writing aggregate reports such as Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) and Risk Management Plans (RMPs) for a range of biopharmaceutical products. He has also conducted several risk:benefit reviews of marketed drugs and biologics and presented drug safety data to UK and EU Advisory Committees such as the UK Commission on Human Medicines (CHM), the European Committe for Medicinal Products for Human Use (CHMP) and the EU Pharmacovigilance Risk Assessment Committee (PRAC). Morell is an expert on the international medical terminology, MedDRA, and served for 10 years as the UK delegate on the MedDRA Management Board, the CIOMS Expert Working Group responsible for development of Standardised MedDRA Queries (SMQs) in conjunction with the MedDRA MSSO and was the EU delegate on the ICH MedDRA Points to Consider Working Group for 10 years. Morell currently runs his own PV, Drug Safety and Risk Management consultancy where he provides strategic guidance and support to bio-pharmaceutical companies regarding regulatory submissions. His current focus is signal detection, benefit-risk evaluation, risk management planning and design and implementation of additional risk minimization measures associated for a range of bio-pharmaceuticals including products used in oncology and Advance Therapy Medicinal Products (ATMPs). Specialties: Risk Management, Benefit-Risk Assessment, Signal Detection, PV System Design and PV Gap Analyses.