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The Implementation of VICH for Good Clinical Practice (GCP) elearning

RQA Member: USD ($) 133.00
Non-Member: USD ($) 173.00

Your Price: USD ($) 173.00

About this course

VICH GL9 (GCP) is an international guidance document that was issued in 2000, with the expectation that all veterinary clinical studies initiated after 2001 would follow the guidance. 
 
This course provides an introduction into the requirements of VICH GCP as applied to the conduct of veterinary clinical studies.  It covers the key roles and responsibilities of the Sponsor, Monitor, Investigator and Quality Assurance.  The design and planning, the conduct and  the subsequent reporting of clinical studies is described, together with guidance on the recording of data.  The content is a reflection of guideline requirements together with some suggestions for best practice
 
Successful completion will enable delegates to gain a comprehensive understanding of the content of the guidance document.

Certificate

Once you have successfully passed the assessment (80% pass mark) you will receive a certificate in PDF format for your records. Please note that you will not have immediate access to this assessment.

Author

Sven’s QA career started with Pharmaco LSR in Suffolk from 1990 to 1995. The role included inspecting and auditing pre-clinical safety studies; acting as Deputy Team Leader and Training coordinator.  From September 1995 until December 1998 he was employed as the Laboratory and Clinical Quality Manager at the Harefield site of Schering-Plough Animal Health, formerly Mallinckrodt Veterinary. 

Since December 1998 he has been self employed as a QA consultant, working for a range of companies involved in the developing and testing of human and veterinary pharmaceuticals and biologics and agricultural chemicals.  The role has included auditing a range of study types, facilities and procedures in GLP studies.  This has included auditing crop residue studies across Europe and beyond since 2000 together with worker re-entry and operator exposure studies.  He has also been involved in auditing veterinary clinical studies since 1995 to date in a range of species, including pigs, cattle, sheep, poultry, fish, horses, dogs and cats. 

Corporate Licences

Multi-user licences for corporate use are also available, please click here for prices and further information.

Course Demo

Course demo not available.

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