| November 2008 - Issue No 200 |
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| EURALex is the definitive balance of legal and regulatory European news to help professionals
from pharmaceutical, veterinary, medical and biotechnology industries enhance
their business strategies. |
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THIS MONTH'S FEATURES:
- Who owns the patents in a joint development?
- Work involving human tissue samples – a new era in the UK
- US and EU pharmacovigilance compared: contemporary approach for spontaneous consumer
report
- Updated medical devices registration on the way for Poland
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INTERVIEW OF THE MONTH
Whilst pharma industry flags, Eucomed enjoys a period of relative tranquillity
The European medical devices industry remains well placed in terms of global
trade, and the level of innovation that derives from the continent is almost undiminished,
says John Wilkinson, Chief Executive of the European medical devices industry
association, Eucomed.
[Read the full interview when you claim your FREE issue] | | |
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EVM lauds EU on pandemic preparedness, whilst urging greater efforts
The European Vaccine Manufacturers group (EVM) has launched an updated “Proposal
for Action” plan with a view to ensuring that Europe is prepared to handle a potential
influenza pandemic. The update coincides with the group’s demand that Member States
and the EU Commission must define effective vaccination strategies for protection
of their populations and set up processes to secure development, purchasing and
deployment of pre- and pandemic vaccines. |
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Inspired by EU Strategy, EFSA sets out goals for contributing to animal health
in Europe
With a view to strengthening its integrated approach towards animal health, the
European Food Safety Authority (EFSA) has set itself six goals that it will pursue
in the near future. The inspiration for the recent authority paper in which the
goals have been set down, is the current EU Animal Health Strategy for 2007-2013.
EFSA believes that it is uniquely positioned to adopt an integrated approach to
animal health, taking into account the relationship between animal welfare, animal
diseases and food safety – areas that are all within the authority’s remit. |
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Poland reviews drug pricing policy and takes a stance against counterfeit medicines
In an attempt to better regulate the price of reimbursed medicines, the Polish
ministry of health has proposed the introduction of fixed price margins for these
products. The proposal has been included in a group of amendments to the country’s
Act on Medicines, alongside other issues relating to clinical trials, advanced
therapy medicinal products, pharmacovigilance and drug counterfeiting. |
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Denmark moves forward on medical devices ordinance amendments
The Danish Medicines Agency (Lægemiddelstyrelsen) has published a draft proposal
to amend its national medical devices and active implantable medical devices ordinances.
The move is designed to update the ordinances in line with EU Directive 2007/47/EC
of 5 September 2007 on active implantable medical devices – which amends Directive
90/385/EEC – and Directive 93/42/EEC on medical devices, which is itself scheduled
for a recast in the coming months. |
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