Microdosing in Drug Development:
Current Status and Future Perspectives

June 16 • 2008 • Maritim Kurhaushotel • Bad Homburg • Germany

One day prior to EUFEPS and Network Conference on June 17-18, 2008

Workshop organised by EUFEPS – the European Federation for Pharmaceutical Sciences – for EUMAPP – the European Union Microdose AMS Partnership Programme
	Funded by the Sixth Framework Programme Contract n°: LSHB-CT-2005-018672

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Scope & Aim & Format
Microdosing is gaining access into drug development, and there is substantial evidence that this methodology is predictive, in many cases. However, can we say that the microdosing-approach is fully verified, and that its place in drug development is well defined? In the Workshop, outcomes of the EUMAPP Project will be presented and put into a wider context, placing microdose predictions beside those of the classical approach. Needs to further verify and validate it will also be discussed, against results obtained by direct comparison between microdosing versus dosing in the pharmacological range.

Additional aims include providing and discussing up-to-the–minute status of microdosing, in podium presentations and discussion sessions. For example, these and other issues will be addressed and discussed in the Workshop: Are there drug class specific concerns? Do biologics behave differently from NCEs? What are the analytical demands, including as to sensitivity and instrumentation, for performing microdosing? Would modelling and simulation enforce the measurements? How well is microdosing accepted by industry and regulators? Are there ethical concerns? Are there technical developments on the analytical side to allow a more widespread use of microdosing? In what direction do future opportunities and developments go?

Scientific Planning Committee
Ole J. Bjerrum (Workshop Chair), University of Copenhagen, Copenhagen DK
Daan J.A. Crommelin, Top Institute Pharma, Leiden NL
Rokus de Zeeuw, BEBO, Assen NL
Colin Garner, Xceleron, York UK
Roeline Jochemsen (Workshop Co-chair), IRIS, Courbevoie FR
Graham Lappin (Workshop Co-chair), Xceleron, York UK
Hans H. Lindén, EUFEPS, Stockholm SE, and
Berend Oosterhuis, PRA International, Zuidlaren NL

Preliminary Programme

Workshop Chair
Ole J. Bjerrum, University of Copenhagen, Copenhagen DK
Workshop Co-Chairs
Roeline Jochemsen, IRIS, Courbevoie FR
Graham Lappin, Xceleron, York UK

Proceedings
Plans include that the outcome of the Workshop should be presented in a report article in European journal of Pharmaceutical Sciences and/or other.

Language
English will be the language of the Workshop. No simultaneous translation will be provided.

Workshop Venue
The Workshop will take place at the Maritim Kurhaushotel which is situated right in the heart of the city of Bad Homburg. It is the same venue as for the EUFEPS and Network Conference taking place on June 17-18, 2008. Bad Homburg can be reached by car or light rail (S-Bahn) from the Frankfurt Main Station (Haupbahnhof) in 15-30 minutes, depending on traffic and train connections.

Disclaimer/Liability
The Organising Committee and Congrex Sweden AB accept no liability for any injuries/losses incurred by participants, nor loss of, or damage to, any luggage and/or personal belongings.

Useful Addresses

EUMAPP
is the European Union Microdose AMS Partnership Programme, coordinated by Xceleron Ltd., York UK, and funded by the European Commission. It comprises 10 organisations from 5 different countries (United Kingdom, Sweden, The Netherlands, France and Poland). The aim is to evaluate microdosing for drug development and to arrive at recommendations about how and when it could and should be used.

EUFEPS
is the European Federation for Pharmaceutical Sciences, the mission of which is to advance excellence in the pharmaceutical sciences and innovative drug research and to represent the interests of scientists engaged in drug research and development, drug regulation and drug policymaking. Currently, it links scientific societies and associations in 24 European Countries, and 10+ member institutions. There are around 600 individual members, and EUFEPS Networks are growing in numbers.