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IBC Life Sciences, Le Royal Meridien Bristol, Warsaw, poland
5 - 8 December 2005
* Following the implementation of the New Medicines
Legislation you can now evaluate its performance in the
CEE, voice your concerns on outstanding problems and
address the consequences of its adoption first-hand
* Gain real practical advice on how to run an efficient
regulatory affairs department in the CEE region to get
your product to market before your competitors
* Evaluate the Mutual Recognition and Centralised
procedures and know how requirements should be adopted
in to your daily routine
* Improve your EU harmonisation strategy, by hearing
agency and industry market updates from new and
candidate countries, including Poland, Hungary and
Romania
* Gain an insight into the impact of EU enlargement on the
generics market and stay ahead of the generics game
* Access the practical reality of the EU Clinical Trials
Directive 18 months after implementation and analyse its
impact on your business
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Organized by:
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IBC Life Sciences |
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Invited Speakers:
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> Rolf Bass, Resident Twinning Advisor (PHARE), Head of
Department URPL (Polish Authority), BfArM, Poland
> Beata Stepniewska, Pharmacist-Regulatory Affairs and EU
Accession, European Generic Medicines Association,
Belgium
> Stanislav Matejek, Regulatory Affairs Manager, IVAX
Pharmaceuticals s.r.o., Czech Republic
> Rodica Badescu, Vice President, National Medicines
Agency, Romania
> Christer Backman, Head of Regulatory Administration, MPA,
Sweden
> Bernard Hart, Director of Clinical Science, AstraZeneca,
UK
> Tamas Paal, Director General, National Institute of
Pharmacy, Hungary
> Vesna Koblar, Head of Regulatory Affairs, Human Unit for
Medical Products and Medical Devices, Agency for
Medicinal Products, Slovenia
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Deadline for Abstracts:
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01/12/2005
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Registration:
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Visit our website for full programme details at:
http://www.ibc-lifesci.com/ceeregulatory
Or call our customer services team:
+44 (0)207 017 5507
or email:
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E-mail:
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charlotte.garratt@informa.com
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