Dr. Malcolm Barratt-Johnson
Regulatory Strategy Expert
Physician with over 18 years pharmaceutical experience in Medical and Regulatory affairs. Extensive experience within both Industry and Governmental Bodies - National and International, leading decision making in the Medical and Marketing Departments of six top ten Pharmaceutical Companies and advising both biotech and generic sectors. Primary medical input into the launch of key products in the Neurosciences/Oncology areas and extensive experience in the Respiratory, Anaesthesia and Women's Health sectors.
Lecturer on the MSc Courses of Surrey and Copenhagen. Immediate Past President of the Section of Pharmaceutical Medicine and Research of the Royal Society of Medicine.
Former Lead Medical Assessor to the Clinical Trials Unit at the MHRA- critiqued and advised Companies and academic Sponsors on over 400 clinical trials in all clinical disciplines including advanced biological compounds.
Lead Assessor in providing medical / scientific advice to more than 25 Companies on their ongoing clinical development and registration programmes.
Lecturer / Speaker- Nationally and Internationally on pharmacovigilance and risk assessment in clinical trials and drug development.
Led Phase III /IV neurosciences / anti-infectives trial programme for AstraZeneca.
Led cross-Company Medical Team's at Pfizer / AstraZeneca
Led the POM to P switch campaigns for EMLA cream and highly successful new campaigns for Meronem (anti-infective), Zydol and Zomig.
As a Medical Assessor to the Medicines Control Agency, licensed 130 medicines under National / Centralised procedures and presented 28 papers to the Committee on Safety of Medicines (CSM)
Specialties: Expertise in Medical Affairs,Clinical Development Plans, Pharmacovigilance review, Regulatory Strategy and Compliance.
Extensive experience in Marketing Support and Medical sign off