LOUISE HARRIS
Title / Position: Clinical Supply, Logistics and Trade Compliance Consultant E-mail Address: Louiseharris23@icloud.com Telephone: +7368600076 Website URL: N/A Social Media Profiles: linkedin.com/in/louiseharris Location: UK Languages spoken: English Geographic Areas Covered: Global Name of Firm: Freelance No. of Practising Consultants: 1
Educational / Professional Background
Academic Qualifications (degrees, diplomas, etc.)
BSc (Hons) Chemistry; MBA Business Administration.
Certifications and Accreditations relating to
Pharmaceutical Good Distribution Practice (GDP)
UK training in import/export & preparing for customs audits.
Membership of relevant professional organizations or
associations
GDP-UCI.
Involvement in GDP-UCI
Goal is to network and share my knowledge as well as find
guidance from other members for specific country regulations.
Professional Skills, Experience and Expertise
No of years of experience in Pharmaceutical Good
Distribution Practice (GDP)
8
Previous Companies worked for in the Pharmaceutical
Industry
PCI (formerly Penn Pharma), Jazz pharmaceuticals (formerly GW
Pharma), PRA / Takeda, ICON, KalVista Pharmaceuticals.
Specific areas of specialism or particular experience
Clinical trial supply, logistics and trade compliance of drug
substance, drug product, IMP, lab kits and other ancillaries.
Familiarity with Specific Regulatory Frameworks and
Guidelines
FDA, MHRA, Eudralex / EMA, TGA.
Relevant Training or Courses Attended
UK training import export & preparation for customs audit. Other
training and courses which can be provided on request.
Software or Technical Skills related to Pharmaceutical
Supply Chain Management
IRT systems, Excel for forecasting, Draw.io for process supply flow.
Client Testimonials / References
Professional references
Available on request.
References or links to case studies / past projects
Other Information
Implementing processes, GDocP, and executing daily activities to
deliver supplies and products to clinical, research or manufacturing
development vendor sites.
Successfully built two departments for KalVista Pharmaceuticals; a
clinical trials supply department, and a logistics and trade
compliance department.
In their own words:
“A well-versed GDP professional with a deep understanding of the supply flow for clinical trials. I am independent, with the ability to work autonomously as well as cross-functionally with a team-orientated mindset”
Good Distribution Practice - Universal Compliance Initiative
GDP CONSULTANTS
