EuroMEEting - Genetic Alliance UK

THEME 13 | THEME 14
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This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.
from industry during the first 3 years of operating under the new scheme
will be presented. Concrete changes to current instruments will be suggested
to address potential identified short comings in order to ensure that the
Regulations’ objectives are effectively met. Reactions and perspectives from
policy makers and regulators will complement the picture.
Industry View of Paediatric Regulation Impact
Ali Harrison, AstraZeneca, UK
What changes would we need to address the findings?
Genevieve Michaux, of Counsel, Covington and Burling, Belgium
Does this Outcome Meet the political Vision?
European Commission speaker invited
Panel with Agnès Saint-Raymond, Head of Human Medicines Special Areas,
European Medicines Agency, EU
16:00-17:30 Session 1308
GLOBAL ACCESS TO VACCINES
Session Chair:
To be confirmed
The explosion of vaccine development in recent years is impressive. However,
as with all medicinal products, there needs to be mechanisms in place to
ensure global access to these vaccines. Various groups have a number of
different initiatives underway to try and achieve this. During this session we
will hear from these groups about their current and future initiatives.
Session under development
Theme 14 | Knowledge Management and Telematics:
Enhancing exchange between industry and regulators
and improving support for their decision-making
Andrew P. Marr, Director, Global eRegulatory Development, Global
Regulatory Operations, GlaxoSmithKline, UK
Timothy Buxton, Head of Sector, ICT Development, European Medicines
Agency, EU
It is evident that data and information, if well-managed, have value and are
worth investment. From these elements come knowledge and knowledge
underpins timely and informed decisions. Data and information can only be
transferred, communicated and managed well through the application of
standards, technologies and carefully considered and optimised processes.
Such a disciplined knowledge-based approach to the development of medical
therapies can lead to better decisions within the industry and by its regulators.
In turn this leads to evidence-based decisions from informed healthcare
practitioners for the benefit of their patients.
The theme will tackle two major challenges. Firstly it will address the strategic
direction within the regulatory and regulated communities and the impact of
changes in the legislation and guidance. The implementation of the regulatory
EU Telematics Strategy and its application within pharmaceutical industry will
be explored through the practical examination of standards, safety analysis and
electronic submissions including those for product information. Case studies
will contribute powerfully to a detailed understanding of the issues involved.
Secondly, the theme will explore the implementation of good knowledge
management practices, both in terms of behaviours and technology. Through
the value added by standards, technology and processes, effective data,
information and knowledge transfer between organisations can be enhanced,
ensuring reliability, accuracy, reproducibility, completeness, traceability,
timeliness and most importantly, that it is fit for purpose for all stakeholders.
Tuesday, 29 March 2011
09:00-10:30 Session 1401
STANDARDISATION: HOW IT REALLY HELPS
Session Chair:
Geoff Williams, e-Regulatory Liaison, Regulatory Operations, Roche Products,
UK
The effort to create global standards has been recognised as a key component
in allowing industry and regulatory authorities to work more efficiently.
Standards to support work in pharmaceutical development are being
developed at global, regional and national levels. After a brief introduction to
set the scene, this session will provide information about three standardisation
projects and how they will help support the goals of industry and regulators.
Individual Case Safety Reports (ISCR): Progress on the development of the
new ISO standard
Anja van Haren, EurdraVigilance Coordinator, Medicines Evaluation Board
(MEB), The Netherlands
Identification of Medicinal Products (IDMP): Progress on the development of
the ISO standard
Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk
Management, European Medicines Agency, EU
CDISC SHARE – Sharing a better understanding of clinical data
David Iberson-Hurst, CDISC Technical Architect, CDISC, UK
11:00-12:30 Session 1402
PRODUCT INFORMATION MANAGEMENT (PIM): IN PRODUCTION –
MIGRATION DEADLINE APPROACHING
Session Chair:
Timothy Buxton, Head of Sector, ICT Development, European Medicines
Agency, EU
Session under development
14:00-15:30 Session 1403
BEST PRACTICE IN ELECTRONIC INFORMATION EXCHANGE FOR
REGULATORY SUBMISSIONS
Session Chair:
Remco Munnik, Regulatory Affairs Information Manager, Sandoz B.V., The
Netherlands
Harmonisation Efforts in Connection with Recent EU Renewals to Prepare
for Product Information Management (PIM), Improve Readability and
Consistency across a Product Family
Maja Nordholm, Regulatory Professional, Novo Nordisk A/S, Denmark
16:00-17:30 Session 1404
STRATEGIC DIRECTIONS IN INFORMATION TECHNOLOGY ACROSS THE
MEDICINES NETWORK
Session Chair:
Katy Page, Senior Director, Worldwide Regulatory Operations, Pfizer, UK
This session will offer several perspectives on the strategic direction for
telematics related to electronic submissions and exchange of information
across the Medicines Network. An industry overview of US priorities will
be followed by a regulator perspective on the status of convergence of
technology and approach across Europe. It will conclude with an explanation
of the future e-submission standard Regulated Product Standards (RPS), and