Ranulf Barman

Solicitor, Latham & Watkins

Mr. Barman has unique experience in the life science sector, previously holding a number of positions in the UK government, including at the Medicines and Healthcare products Regulatory Agency (MHRA) and the Food Standards Agency (FSA), respectively. Mr. Barman has represented the UK government at EU level on a broad range of compliance and regulatory issues concerning food and medical devices.

Mr. Barman focuses on matters in the life science sector, advising public and private multinational pharmaceutical, biotechnology, medical technology, diagnostics, food, and cosmetic companies and their investors on complex licenses, collaborations, acquisitions, divestments, commercial contracts, intellectual property matters, and regulatory and privacy matters.

Mr. Barman maintains an active pro bono practice, regularly advising international charities in relation to their regulatory and commercial needs.

Prior to joining Latham, Mr. Barman was a solicitor at an International law firm, where he also trained, as well as completing an in-house secondment at a US energy company.

Contributed to

2

EU Pharmacovigilance

Practice Notes

This Practice Note deals with pharmacovigilance. It sets out the EU regulatory framework and discusses the role of the Pharmacovigilance Risk Assessment Committee (PRAC), EudraVigilance and the guidelines on good pharmacovigilance practices (GVPs). It then takes a more detailed look at the pharmacovigilance processes and requirements set out in the GVP modules, including: how to establish a pharmacovigilance system, the qualified person responsible for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF), pharmacovigilance inspections, pharmacovigilance audits, periodic safety update reports (PSURs), and post-authorisation safety studies (PASS). The Practice Note then considers non-compliance with pharmacovigilance requirements, data protection considerations, and outsourcing pharmacovigilance activities.

EU Law

Pharmacovigilance

Practice Notes

This Practice Note deals with pharmacovigilance. It sets out the EU and UK regulatory framework and discusses the role of the Pharmacovigilance Risk Assessment Committee (PRAC), EudraVigilance and the guidelines on good pharmacovigilance practices (GVPs). It then takes a more detailed look at the pharmacovigilance processes and requirements set out in the GVP modules, including: how to establish a pharmacovigilance system, the qualified person responsible for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF), pharmacovigilance inspections, pharmacovigilance audits, periodic safety update reports (PSURs), and post-authorisation safety studies (PASS). The Practice Note then considers non-compliance with pharmacovigilance requirements, data protection considerations, and outsourcing pharmacovigilance activities. Finally, it discusses pharmacovigilance in the UK and the role of the Medicines and Healthcare products Regulatory Agency (MHRA).

Life Sciences