Title:
Training course on Practical GCP Compliance Auditing of Trials & Systems
Date(s) And Time(s):
Oct 6 2010 7:30AM - Oct 8 2010 2:30PM
Location:
Holiday Inn Kings Cross
1 Kings Cross Rd.
London
WC1X 9HX
United Kingdom
Interest Area(s):
CMC,Clinical Safety/Pharmacovigilance,Project Management,Quality Assurance/Quality Control
Overview:
The contents and structure of the course have been refreshed to more clearly reflect current items of key importance, the so called ‘hot topics’. More emphasis is placed on interactive sessions and the improved design of the course will provide many more opportunities for delegates to get right to the heart of the issues that interest and concern them.
This GCP auditing course is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. The ICH GCP guideline implemented in the EU, Japan and the USA is being widely incorporated into guidelines worldwide. Systems audits, previously seen as "advanced auditing", have become a basic task of many audit groups and are an essential element of inspections in Europe.
The course material is regularly updated with the objective of experience sharing and a common professional approach in order to pave the way for mutual recognition and acceptance, reducing costs and stimulating efficiency, allowing faster medicinal product development to the benefit of the patients and health care.
Key Topics:
- Regulatory Framework EU and ICH and Quality Management
- Trial audit in practice
- Systems audits
- Communication of audit findings
- Inspections by European and other authorities
Learning Objectives:
At the conclusion of this course, participants should be able to:
- Apply common audit methodology principles to clinical trials in Europe and other countries
- Compare trial specific and system audits
- Formulate audit findings in clear and precise language
- Discuss requirements for inspections
Target Audience:
This course is designed to provide practical training for industry auditors and regulatory authority inspectors, who are faced with the challenging task of auditing or inspecting clinical trials and related systems. It will also be of interest to those with managerial responsibilities.
CANCELLATION POLICY
Cancellations must be made in writing and be received at the DIA Europe office five working days prior to the course start date.
Cancellations are subject to an administrative fee:
Full Meeting Cancellation:
Industry (Member/Non-member) = € 200.00
Government/Academia/Non-profit (Member/Non-member) = € 100.00
Registrants who do not cancel five working days prior to the course start date and do not attend, will be responsible for the full registration fee. DIA Europe reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA Europe is not responsible for airfare, hotel or other costs incurred by registrants. Registrants are responsible for cancelling their own hotel and travel reservations.
Transfer Policy
You may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.
Event Code:
10546
Contact Information:
DIA Europe
ELISABETHENANLAGE 25
POSTFACH
4002 BASEL
SWITZERLAND
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52
Email: DIAEUROPE@DIAEUROPE.ORG
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