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Nov 6 2014 8:00AM - Nov 7 2014 5:30PM | Pullman Basel Europe
Save up to €300 with the Early-bird rate!See bottom of page for fees
Data integrity surrounding computerised system supported business processes throughout the product life cycle has been at the forefront of recent news, for example Ranbaxy in the USA. The awareness of these issues has changed the approach used by both EU and US regulators in conducting inspections in recent years. As data integrity increasingly becomes a focus of the regulatory authorities, the industry has to recognise and ensure controls for data integrity are implemented and appropriately managed throughout the entire life cycle of the data. Problems with data integrity manifest themselves differently in each phase of the life cycle. Therefore improvements must be managed differently during each phase, based on business risk.
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. It will focus on the work being conducted by two leading organisations within the life sciences sector who approach the subject from differing directions but with the same clear objective of ensuring data integrity to reduce the risk to the patient. It will focus on the well-established approaches used, identifying the similarities of key principles and practice, and the challenges facing the industry with the availability of new technologies such as cloud computing.
This conference is aimed at intermediate and experienced professionals from:
Participants will gain an awareness of the principles of the GAMP® 5 risk-based approach to compliant GxP computerised systems and how they support the maintenance of data integrity. Understand the principle regulatory concerns and how they may be addressed. Discuss and identify the key challenges and opportunities of the new technology. Recognise how companies and industry organisations are developing principles and practical advice to meet these challenges to data integrity throughout the entire product life cycle. Have the opportunity to exchange views between regulators, industry and other stakeholders.
DIA has blocked a limited number of rooms at the following hotel:
Pullman Basel EuropeClarastrasse 434058 Basel Switzerland
Tel.: (+41)61/6908700 Fax: +44 20804348Fax: (+41)61/6908880Email: email@example.com
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.
Registration QuestionsPhone.: +41 61 225 51 51 Fax: +41 61 225 51 52 Monday-Friday 8:00-17:00 CETdiaeurope@diaeurope.org
Agenda and Event LogisticsMagdalena Lewandowska, Event ManagerPhone: +41 61 225 51 65Fax: +41 61 225 51 firstname.lastname@example.org
Global Head GxP IT Systems & Processes Novartis Pharma AG, Switzerland
Senior Project ManagerAquaDania a/s , Denmark
Head of Computerised Systems QAComputerised Systems QA Bard Pharmaceuticals Ltd, United Kingdom
Legal RepresentativeOptum, United Kingdom
This opening session will provide an insight into the regulatory challenges facing the life sciences industry from the emergence and introduction of new technologies such as cloud computing and mobile applications/devices and the impact upon data integrity. It will also look at how we may adopt a risk-based approach to ensuring continued GxP compliance of computerised systems in this new environment.
Whilst 10 years ago, Computerized Systems Validation was a priority for many organisations, the today’s industry and regulators key focus is on data integrity. As a prerequisite for end to end clinical data integrity, computerized systems have to be validated and to be kept in a validated state. In particular in large Pharmaceutical Organizations and with full service providers, there is a level of Systems, Process, Organizational and Geographical Complexity that require another layer of governance and oversight than the typical controls described in numerous publications. Furthermore, additional data collection tools such as ePRO systems and eSource data concepts have to be properly integrated in clinical study setups.
The objective of this session will be to consider how eClinical IT systems and platforms can enable end-to-end data integrity in today’s context of further going electronic and paperless, implementing global data management operations, insourcing of resources and outsourcing of services. In addition, Systems retirement and data storage and archiving will be addressed.
These are challenging times for most pharmaceutical companies. The competiveness of the market place, loss of patents, increasing international regulatory requirements, and downward pressure on health care costs are just a few of the factors that are driving pharmaceutical companies to adopt strategies for cutting resources and costs. At the same time IT needs to support the challenges the businesses are facing and are being asked to deliver effective solutions while cutting costs without compromising quality, compliance, agility and flexibility. This has led to greater interest in Cloud Computing. The promises of cloud computing are certainly considerable: extremely fast and flexible solution delivery, on-demand scalability, high-demand business continuity services with easy solutions for backup and archiving. This session aims to look at the issues surrounding the adoption of such technologies and asks “Will cloud computing provide the capabilities and adoption levels while simultaneously meeting the regulatory compliance needs that are core to the Pharmaceutical sector?”
The accessibility of mobile platforms to the general public has become nearly universal in much of the world. In 2013 sales of smartphones exceed the sales of standard mobile phones, and this trend shows no sign of slowing. With this much computing power in everyone’s pocket it was inevitable that regulated companies would recognize an opportunity to use it for a variety of purposes. Some examples of leveraging mobile technology are relatively low impact and will not interest regulators, some fall very clearly into the regulated arena, and finally some are not so clear. Even once the scope of regulatory relevance is settled, mobile devices present a significant challenge to control. The possibility of putting regulated applications, some of which may be classified as medical devices, into the pockets of the public is new ground for the industry. Never before has regulated software run on platforms where the process owner has little or no control over the platform. This session is intended to consider a risk-based approach to implementing and supporting mobile devices in a regulated environment.