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Practical GCP Compliance Auditing of Trials and Systems

Oct 23 2013 8:00AM - Oct 25 2013 3:30PM | Holiday Inn London Kensington Forum 97 Cromwell Road London SW7 4DN United Kingdom

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Overview 

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.

What You Will Learn 

  • Regulatory framework EU and ICH
  • Quality management, defining quality, risk-based approach to audit and inspection
  • Trial audit in practice
  • System audits
  • Communication of audit findings
  • Inspections by European and other authorities

Who Should Attend 

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.

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

Hotel & Travel 

The DIA has blocked a limited number of rooms at the following hotel:
Holiday Inn London – Kensington Forum
97 Cromwell Road
SW7 4DN London
United Kingdom

Tel.: +44 207 341 8000
Website: http://www.hikensingtonforumhotel.co.uk/

at the rate of:
GBP 162.00 per room/night inclusive of breakfast and VAT.

In order to make your reservation, please contact the hotel directly at +44 207 341 8000 and quote the booking reference: DDB.

Important: The room rate is available until 16 September 2013 or until the group block is sold-out, whichever comes first.

Contact Information 

DIA Europe
Kuechengasse 16, Postfach
4002 Basel
Switzerland

Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org

 

Faculty 

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Registration Fees 

Member

Charitable Nonprofit/Academia Member
€893.00
Member Government
€893.00
Member Standard
€1785.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€1008.00
NonMember Government
€1008.00
NonMember Standard
€1900.00
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CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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