Session Highlights at the EuroMeeting
2013
Among the packed conference programme of the EuroMeeting are a few sessions,
that you definitely don't want to miss. Hot topics, presentations delivered by
high level speakers, and the opportunity to discuss current issues with fellow
professionals and our special presenters.
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Opening Plenary: Public/Private Partnerships –
Working Together in the Interest of Patients
4 March |
14:00-17:15Public-private
partnerships (PPP) are collaborative relationships that transcend national
boundaries. Each partnership brings together at least a corporation or an
industry association and intergovernmental organisations to achieve a shared
health-creating goal on the basis of a mutually agreed division of tasks. The
positive aspects and concerns of these initiatives will be discussed.
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Moderator:
Steffen Thirstrup, Head of
Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines
Authority, Denmark
Panelists:
Jan
Geissler, Director, EUPATI, Belgium
Kemal Malik,
Head of Global Development, Member of the Bayer HealthCare Executive Committee
and Chief Medical Officer, Bayer HealthCare Pharmaceuticals, Germany
Pat O’Mahony, Chief Executive, Irish Medicines Board,
Ireland
Luca Pani, Director General, Italian Medicines
Agency (AIFA), Italy
Andrzej Rys, Director of Health
Systems and Products, European Commission, EU
Harpreet
Singh, Managing/CSO, Immamics Biotechnologies, Germany
Sessions
1803/1804: GCP Hot Topics
5 March |
14:00-17:30
Session Chairs
Gabriele Schwarz,
Head, GCP Inspection Services, German Federal Institute for Drugs and Medical
Devices (BfArM), Germany
Beat Widler, Senior Partner, Widler
& Schiemann, Switzerland
The GCP Hot Topics Sessions that in recent
editions of the EuroMeeting have been bringing together regulators, industry,
CRO and academia professionals who want to get first hand information on newest
trends, has by now become a EuroMeeting tradition.
In 2013 the impact of
changes and evolutions in technology on the conduct and quality management of
clinical trials determine the programme of the GCP Hot Topic session. The focus
will be on electronic health records (EHRs) when used as source documents or
direct input source into clinical trial databases. As a second topic the session
will deal with the challenges presented to sponsors and CROs when clinical trial
activities are outsourced. This topic is not new but becomes increasingly a root
cause of major and critical inspection findings. The program will be completed
by the presentation of the White Paper on protocol violations that has been
authored by the GCP SIAC.
As in other years the roster of international
speakers will involve senior representatives from health authorities, industry
and CROs. The audience is invited to actively participate in the panel
discussions by bringing examples or challenging statements. Delegates can
anonymously submit topic-related questions or cases they would like to be
discussed by the panel in advance to the session chairs via the DIA.
Session
1805: EMA Roundtable – Scientific Committees United in Diversity
6 March
| 9:00-10:30
Session Chair: Hans-Georg Eichler,
Senior Medical Officer, European Medicines Agency, EU
This roundtable will discuss how the EU Scientific Committees come together
and interact at the European Medicines Agency to foster scientific excellence in
the evaluation and supervision of medicines for the benefit of public health,
while being enriched by the EU’s many different cultures and traditions.
Session
1207: Regulatory Town Hall Meeting
6 March |
14:00-15:30
Session Co-Chairs: Guido Rasi,
Executive Director, European Medicines Agency, EU and Christa
Wirthumer-Hoche, Member CMDh, Deputy Head, Austrian Medicines and
Medical Devices Agency (AGES), Austria.
At the Town Hall Meeting attendees can put burning questions to
experts about these topics:
• Latest views on legislative
changes
• Implementation of the new pharmacovigilance legislation
•
Transparency
• Drug shortages
• Decision making
• New approaches to
licensing
Download the full Conference
Programme and read about these, and the 110+ other sessions,
the exhibition and other activities the EuroMeeting has to offer. If you have
any specific questions, please feel free to contact
us.
Make the most of your EuroMeeting
Experience - register for a Pre-Conference
Tutorial
Monday, 4 March | 09:00-12:30
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meeting and provides a unique opportunity to interact with professionals from
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from patient organisations and much more.
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