Title / Position: Freelance Consultant E-mail Address: Telephone: +33777950242 Website URL: N/A Social Media Profiles: 0464905 Location: France Languages spoken: English, French, basic Spanish Geographic Areas Covered: Global Name of Firm: Freelance No. of Practising Consultants: 1
Educational / Professional Background: Academic Qualifications (degrees, diplomas, etc.) MSc (centre for tropical vet med, Edinburgh), BSc (Biology, Hull) Certifications and Accreditations relating to Pharmaceutical Good Distribution Practice (GDP) GxP audit certification (Institute of Applied Pharmaceutical Sciences, NJ, USA) Membership of relevant professional organizations or associations Involvement in GDP-UCI Member of Governance Council and Advisory Board. Advisor to GDP-UCI Launch Manifesto
Professional Skills, Experience and Expertise No of years of experience in Pharmaceutical Good Distribution Practice (GDP) 15 + 20 in clinical trials, regulatory affairs, pharmacovigilance and GMP. Previous Companies worked for in the Pharmaceutical Industry: Pfizer Specific areas of specialism or particular experience (e.g. training, auditing, QMS development, RP services, licence applications etc.) QMS, GDP audit and regulatory interpretation. Importation (financial vs physical). Supply Chain resilience. QMS design and deployment for GDP Certification for LSPs new to pharma. Familiarity with Specific Regulatory Frameworks and Guidelines EMEA - contributed via EfPIA to EU GDP Guideline revision WHO - contributed via IFPMA to WHO GDP Guideline revision Relevant Training or Courses Attended Multiple in-house (Pfizer) and external (ISPE, IQPC, PDA, EfPIA) GMP, GCP, GDP courses and seminars Software or Technical Skills related to Pharmaceutical Supply Chain Management IT-fluent - most systems eg microsoft, and specialised QMS applications eg Trackwise modules. Inventory management and temperature tracking system design
Contact us +44 (0)207 096 9119 By-the-industry, for-the -industry:  a member-driven GDP initiative  Contact us By-the-industry, for-the-industry:  a member-driven GDP initiative
Other Information: Able to translate through a pragmatic approach, the theory of Guidelines to practice in high-risk environments, and to raise awareness through management, to convert non-pharma logisticians to specialist GDP practitioners. Speaking engagements: multiple e.g. IQPC, LogiPharma, including "GDP for Africa" training modules for Distributors (Rx360), and GDP training of MoH Inspectors including UK MHRA, and African Union Member State MoHs. Specific areas...: QMS design and deployment for GDP Certification for LSPs new to pharm

In their own words:

“I advise distributors in deploying a QMS for GDP compliance and product quality assurance, with focus on last-resort supply in high-risk regions, and humanitarian scenarios.”
GDP-UCI Consultant Register Terms & Conditions of Use
Good Distribution Practice - Universal Compliance Initiative