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
Contact us +44 (0)207 096 9119 info@GDP-UCI.org By-the-industry, for-the -industry:  a member-driven GDP initiative  Contact us info@GDP-UCI.org By-the-industry, for-the-industry:  a member-driven GDP initiative
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”
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