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Mon 16 Apr 2007
- Thu 19 Apr 2007
Danubius Hotel Gellert, Budapest, Hungary
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Gain a market update from both Romania and Bulgaria following their recent entry into the European Union. Learn about the challenges faced by Accession Member States and how these were overcome. Poland, Czech Republic, Hungary and Slovak Republic present on the hottest topics within product registration. This will provide the perfect opportunity to share knowledge with all EU colleagues and help harmonise best practice.
Hear critical feedback from three regulatory bodies and ensure your product is first to market:
Medicines Agency, Romania
Medical Products Agency, Sweden
National Institute of Pharmacy, Hungary
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Don't Miss
Plus don’t miss our full day workshops:
Monday 16th April 2007
Understanding the Decentralised Procedure
Workshop leader: Lutz Müller, Head of Regulatory Affairs, Dr. Regenold GmbH, Germany
Thursday 19th April 2007
Successfully Tackling Parallel Trade
Challenges
Workshop leader: Fabrizio Gianfrate, Professor of Health Economics and Pharmaceutical Management, University of Ferrara, Italy
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Key Presentations
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Rodica Badescu, Vice President, National Medicines Agency,Romania
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Andrey Mladenov, Director Medical and Regulatory Affairs,Sopharma Pharmaceuticals, Bulgaria and Board Member of Association of Bulgarian Pharmaceutical Manufacturers (ABPhM), Bulgaria
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Christer Backman, EU-Coordinator and Policy Adviser, Medical Products Agency, Sweden
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Herta Pálfi Goóts, Manager, Regulatory Affairs, Gedeon Richter Ltd, Hungary
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Tamas Paal, Director General, National Institute of Pharmacy, Hungary and Director, Department of Drug Regulatory Affairs,
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University of Szeged, Hungary
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Klaas Postema, Genesis Capital, Romania
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Majella Ryan, Director, Ivowen Ltd, Ireland
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Barbara Gollob, International Medical Manager, Sandoz GmbH, Austria
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Luis González Vaqué, Advisor, Internal Market and Services, European Commission, Belgium
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Ewa Lepczy´nska, Regulatory Affairs Director, Polpharma, Poland
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Stanislav Matejek, Regulatory Affairs Manager, TEVA Pharmaceuticals, Czech Republic
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Ludevit Martinec, Expert for International Affairs-European Integration, Slovak Office of Standards, Metrology and Testing, Slovak Republic
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Thomas Steinbach, Qualified Person for Pharmacovigilance, Wyeth European, UK
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Susanne Kaufmann, Variation Manager, Variation Management & Compliance, Bayer Schering Pharma, Germany
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Joerg Schnitzler, Regulatory Operations Manager, Merck KGaA, Germany
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Diana Taylor, Medical Writer & In-house Instructor, PAREXEL International GmbH, Germany
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Stewart Green, Director of Quality,Wyeth, UK
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John Jolley, Pharmaceutical Consultant, UK
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