# Vicarius Leadership Team – Executive Profiles

Post-Approval Regulatory Affairs

### Professional Experience

Pharma Labelling Consultancy, Founder & Consultant, United Kingdom

Director of International Affiliate Labelling & Promotion, Biogen

Director of Global Regulatory Labelling, Biogen

Director of Global Core Labelling Management, GlaxoSmithKline

Manager in Clinical Prescribing Management, GlaxoSmithKline

Scientific Regulatory Project Manager, GlaxoSmithKline

Research Scientist, Charing Cross and Westminster Hospital

### Biogen

• Advocate for development project teams to utilize Competitive Labelling Assessments and Target Labelling Profiles
• Developed Labelling SOPs and guidance documents for global and regional businesses to facilitate compliance/regulatory inspections
• Key partnership with Pharmacovigilance to develop effective processes to manage Development Core Safety Information and Patient Safety Information
• Managed the implementation of Risk Management Plan/Physician Information Document in the European Union

### GlaxoSmithKline

• Was instrumental in development of new Pharmaceutical Central Labelling organization following a major restructuring of Clinical and Prescribing Information Management (CPM)
• Managed several products through the Centralised, Mutual Recognition/Decentralised, and National procedures

### Education

Ph.D., Imperial College of Science, Technology and Medicine, London

B.Sc., Zoology, Leeds University

British

English

## Member Profiles

• President and CEO
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• Pre-Approval Regulatory Affairs
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• Chief Compliance Officer
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• Vice President, Market Access
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