SHORT COURSES

Summary of Topics and Presenters - click the course title for details of the course. Please note that, for logistical reasons, the number of Short Courses has been reduced from those originally announced. Some of the issues to be raised in BIOVAL 2000 will now be presented in the main Congress programme.

1. EUROPEAN STRATEGIES FOR HARMONISATION AND DRUG REGISTRATION
(Half-day course, 9.30-12.30, 16 September)
Presenters: T. Paál (Budapest, Hungary, Co-ordinator), A. Artiges (Strasbourg, France), R. Bass (London, UK)

2. THE ASSESSMENT OF ORAL DRUG ADSORPTION
(Full-day course, 9.30-12.30 and 14.00-17.00, 16 September)
Presenters: J.J. Tukker (Utrecht, The Netherlands, Co-ordinator),
J.B. Dressman (Frankfurt-am-Main, Germany), C.-M. Lehr (Saarbrücken, Germany),
H. Lennernäs (Uppsala, Sweden), C. Efthymiopoulos (Geneva, Switzerland)

Click here to view the printable application form for Short Courses

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1. EUROPEAN STRATEGIES FOR HARMONISATION AND DRUG REGISTRATION
(Half-day course, 9.30-12.30, 16 September)
Presenters: T. Paál (Budapest, Hungary, Co-ordinator), A. Artiges (Strasbourg, France)
R. Bass (London, UK)

Workshop outline

This Workshop will address a number of European issues that impact on pharmaceutical development. The globalisation of medicine assessment in recent years includes the International Conference on Harmonisation (ICH), involving the USA, European Union and Japan, plus specific European strategies for harmonisation. The European Union (EU) has developed supranational procedures for new medicine assessment and marketing authorisation. These together with the relevant EU Directives should also be implemented by the 11 EU Associated (candidate) countries. The European Pharmacopoeia Convention has made the Pharmacopoeia an integral part of European medicine marketing authorisations, by introducing the "Certificate of Suitability" system.

The Official Medicine Control Laboratories (OMCL) network is also organised under the aegis of the EP Convention. For non-EU countries with high standards the former, open EFTA conventions (e.g. the Pharmaceutical Inspection Convention, PIC) and schemes such as the Pharmaceutical Evaluation Report Scheme, PER offered opportunities for international collaboration. The Collaboration Agreement between Drug Regulatory Authorities in the European Union Associated Countries (CADREAC) initiative has made it possible for the participating countries to work, at a professional level, together with non-decision-making EU bodies. In 1999, it led to the establishment of the Pan-European Regulatory Forum (PERF), a unique collaboration at drug regulatory authority level, also comprising all interested non-EU and non-CADREAC authorities as observers. The implications of these developments will be discussed in the context of closer collaboration at the European level.

2. THE ASSESSMENT OF ORAL DRUG ADSORPTION
(Full-day course, 9.30-12.30 and 14.00-17.00, 16 September)
Presenters: J.J. Tukker (Utrecht, The Netherlands, Co-ordinator), J.B. Dressman (Frankfurt-am-Main, Germany), C.-M. Lehr (Saarbrücken, Germany)
H. Lennernäs (Uppsala, Sweden), C. Efthymiopoulos (Geneva, Switzerland)

Workshop outline

This short course is designed to help those in preclinical evaluation of new drugs and formulations to identify and solve problems with oral absorption. An integrated approach using in vitro, ex vivo, in situ, whole animal and human studies will be presented, including explanation of high-throughput screening techniques. Interpretation of available pharmacokinetic data will also be discussed. A Panel Discussion will discuss case examples of problematic drugs/formulations, as well as the appropriate balance of experiments needed to optimise the preclinical R & D process.

Topics: Physiologically based dissolution tests. Ex vivo and in situ models for evaluation of oral drug absorption. The use of cell cultures, with special emphasis on automated procedures. Permeability studies in humans. Interpretation of drug absorption data: methods, software and some examples for application.

SHORT COURSES