ISPE and DIA Workshop on Computer Systems Compliance

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6-7 November 2014
Basel, Switzerland

Overview

  • Data integrity surrounding computerised system-supported business processes throughout the product lifecycle has been at the forefront of the news. The awareness of these issues has changed the approach used by both EU and US regulators in conducting inspections in recent years.
  • This 2-day conference will provide a forum for information, discussion on conceptual and practical questions and experience exchange through lectures, panel discussions and interactive workshop sessions.

Key Topics

  • The regulatory perspectives on data integrity and the use of new technologies
  • The principles of GAMP®5 and its relationship to clinical systems
  • Understanding business process risk management
  • Maintaining data integrity
  • The challenges to the industry and regulators of emerging computing strategies such as the use of mobile and cloud-based platforms

Interactive Workshop Sessions

  • Data Integrity and a Risk-Based Approach
  • Enabling Data Integrity With E-clinical Systems
  • The Challenges of Cloud Computing
  • Regulated Mobile Applications

Panel Discussion

There will be panel discussion with session speakers and Q & A.

Networking Reception

Have the opportunity to exchange ideas and network in an informal setting with colleagues, regulators and industry leaders.

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Registration Fees

Full Conference Fees

  Member Non-Member
Standard (Before 25 August 2014) €1300 €1600
Standard (As of 25 August 2014) €1450 €1600
Government €725 €855
Academia €725 €855
Student €200 €200

Single Day Fees

  Member Non-Member
Standard €870 €960
Government €435 €513
Academia €435 €513
Student €200 €200

Register Online »

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Hotel

Pullman Basel Europe
Clarastrasse 43
4058 Basel, Switzerland

Tel.: (+41)61/6908700
Fax: +44 20804348
Fax: (+41)61/6908880
Email: h5921@accor.com

There are a limited number of rooms at the Pullman Basel Europe researved for this event at the rate of CHF 180 per room inclusive of breakfast, wifi and the mobility ticket for free use of public transport
To make your reservation please use this booking form.

Important: The room rate is available until 9 October 2014 or until the group block is sold-out, whichever comes first.

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Programme Committee- Representing DIA

  • Rolf Banholzer, Global Head GxP IT Systems & Processes, Development QA, Novartis Pharma AG, Switzerland
  • Breffni Martin, Legal Representative, Optum, Ireland

Programme Committee- Representing ISPE

  • Chris Clark, Head of Computerised Systems QA, Bard Pharmaceuticals Ltd, United Kingdom
  • Anders Brummerstedt, Senior Project Manager, PEC A/S, Denmark

Exhibition opportunities

This conference is being conducted by two leading organisations, ISPE and DIA, within the life science sector who approach the subject from different directions but with the same clear objective of ensuring data integrity to reduce the risk to the patient.

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