The Malta College of Pharmacy Practice in collaboration with Malta Enterprise is
organising a presentation on
Speaker: Dr Fergal Donnelly, MD, MSc, FFPM
Scientific officer, Biotechnology and Applied Genomics Unit,
Directorate Life Sciences F
Directorate General Research and Technology Development
European Commission

Date: 27th April 2006

Time: 7.30pm for 8pm
Refreshments will be served from 7.15 to 8.00 pm
Venue: Malta Enterprise
Enterprise Centre
Industrial Estate
San Gwann

For further information and to register please send an e-mail on The meeting is eligible for accreditation with the Malta College of Pharmacy Practice

Note: There is NO registration fee.

Topics to be addressed:
Clinical trials
What are the new modalities for performing clinical trials? Databases and biobanks will be the lynchpin of clinical trials in the future, cutting their costs by at least 50% and shortening their duration. The result will be the delivery of innovative medicines to European citizens faster than before.

Small and medium sized enterprises are the key to Europe's future in innovation. There are new provisions in the revised European pharmaceutical legislation to help SMEs get into the pharmaceutical market through fast track registration procedures, fee deferrals and waivers and free scientific advice prior to product development aimed specially at the SME sector. In addition, there are special measures in the
European Commission's Framework Programmes that are especially dedicated to SMEs.

Pharmaceutical Industry R&D
One of the major objectives of the European Union (EU) is to build the most competitive and dynamic knowledge-based economy in the world by 2010. A key element of this objective is the strengthening of the science base in Europe. The
biopharmaceutical environment is characterised by its focus on science and innovation. The Innovative Medicines Initiative will strengthen the biomedical R&D environment in Europe to benefit patients and society by increasing the efficacy of
drug discovery and development, through earlier and better prediction of efficacy and safety, as well as integrating the different aspects of knowledge management throughout the whole R&D process.

Educating professionals for future needs
A new European Medicines Research Academy will be the focal point for bridging gaps between the different types of expertise (industrial, academic, financial, regulatory and patient organisations) that are all collectively required to strengthen the biopharmaceutical R&D process. Known as "Translational Medicine", this new discipline will break down the bottlenecks in the research and development path from
bench to bedside. It will also be the European centre for Continuous Professional Development and ensure that European graduates in various scientific disciplines related to pharmaceutical R&D can find employment in their field anywhere in the EU

Acting alone, neither biopharmaceutical companies nor academia and member states can solve the problems facing Europe today. When implemented as a joint effort, the Innovative Medicines Initiative will accelerate the development of safe new and more effective medicines, bring tangible benefits to patients and making the European biopharmaceutical research environment competitive at a world level.

Patient Safety
The Innovative Medicines Initiative will be responsible for a better and earlier prediction of drug safety through new alternatives to animal testing, through the creation of a European Centre for Drug Safety that will monitor all aspects of safety profiling from preclinical to clinical development as well as pharmacovigilance once new drugs are placed on the market.

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