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.
