The Importation of clinical trials materials into Europe : Tips to follow and pitfalls to avoid

Instructor: Chris Barnett
Product ID: 700230
Training Level: Intermediate
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Nov-2006

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This Clinical trial training will be highlighting some of the pitfalls, and to provide some guidance to companies wanting to import products into Europe for use in clinical trials.

Following the transposition of the Clinical Trial Directive into EU law in 2004, the requirements for the importation of products for investigational purposes changed significantly compared with the previous situation. There still remain, however a number of misunderstandings regarding the legalities of importation, and the requirements for QP certification of imported product.

With a number of examples from recent experience, Chris Barnett, a QP with a number of years experience in investigational products will attempt to highlight some of the pitfalls, and to provide some guidance to companies wanting to import products into Europe for use in clinical trials.

Areas Covered in the Seminar:

  • Review of 2001/20/EC implementation
  • Roles of the various organizations involved in the supply chain
    • Trial Sponsor
    • Manufacturer
    • Importer
    • Packager
    • Qualified Person
  • Manufacturing/Supply Chain Contracts and Technical Agreements

Who Will Benefit:

  • Clinical Trial Sponsors
  • Clinical Investigators
  • Regulatory Affairs staff
  • CRO staff
  • Importers of CTM
  • QPs
  • Purchasing and contract management specialists

Instructor Profile:

Chris Barnett had over 20 years international experience with major pharmaceutical companies covering analytical chemistry, QA management, and technology transfer and manufacturing strategy. Director of Quality and Compliance of Pharmaceutical Development Services Ltd, a consultancy company based in the UK, he specializes in quality systems, auditing, validation, and contractor management, especially for companies in the early phases of development. Chris is eligible to be nominated as a Qualified Person under the permanent provisions of the EU Directives. He is a Chartered Chemist, a member of ISPE and of the Pharmaceutical Quality Group and has trained as an ISO9000:2000 lead auditor.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

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