Brian has been with NDA since 2007, introducing pharmacovigilance services to our clients in a wide range of therapeutic areas. This includes the provision of a qualified person for pharmacovigilance services, quality management including pharmacovigilance audits and medical input into various regulatory projects including approval of promotional material.
Key Areas Of Expertise
- Medical Safety & Pharmacovigilance
- Contract Qualified person for pharmacovigilance for six companies
- All aspects of medical safety such as case review, periodic safety update reports, signal detection, safety study design and protocols, review of clinical study reports
- Medical support for regulatory teams in preparation of marketing authorisation applications and all form of regulatory agency meetings
- Pharmacovigilance audits of large and small multinational pharmaceutical companies and PV vendors based on both EU and US legislation
- Direct involvement in a wide variety of risk management plans covering both new chemical entities and generic products
- Training in process improvement, specific topics such as periodic safety update reports, good labelling, practices inspection preparation
- Review and approval of EU promotional material
Brian spent 14 years in hospital medicine and clinical research finally obtaining his MD. He was senior pharmacovigilance assessor for 5 years in the UK regulatory agency (MCA). This was followed by 6 years as Senior Medical Director in a global CRO involved in pharmacovigilance in all phases and clinical trials. He was then deputy QPPV for Janssen-Cilag for 18 months.
- Chair Medication Errors Special Interest Group, International Society of Pharmacovigilance
Chair Pharmaceutical Sector Human Factors Group in Chartered Institute Ergonomics and Human Factors.
Previously Brian sent up the EU QPPV forum and was on the planning committee from its inception in 2005 until 2018
Previously the QA convener on the panel appointed by the UK Faculty Pharmaceutical Medicine to oversee Drug Safety Surveillance Module as part of Pharmaceutical Medicine Specialist Training until July 1st, 2015
Dr Brian Edwards