EUFEPS & COST B25
	Conference on

Bioavailability (BA)
and Bioequivalence (BE)

Focus on Physiological Factors and Variability

October 1-2 • 2007 • Royal Olympic Hotel • Athens • Greece

Index » Preliminary Programme » Click for Registration on-line » Click for Registration Form (PDF) » Click for Editorial Intructions » Useful Addresses » Click for Final Programme including time-schedule » Click for Additional Information   Download the 2nd Announcement To read PDF files you will need the software plug-in Acrobat Reader, which is a free shareware from Adobe. Click here if you wish to download the shareware.

This Conference opens on Monday, October 1, at 08:45 (Pre-registration on Sunday, September 30) and it closes on Tuesday, October 2, at 16:00.

Scope and Aim
There are concerns about highly variable drugs and drug products. Physiologically based approaches to understand drug absorption and the bioavailability of drugs and drug products have gained major interest over the recent years. This is why physiology and factors of variability affecting the oral absorption and the systemic availability of drugs and drug products will be addressed in this Conference.

It will also provide good insight in current thinking as to the design and analysis of bioavailability and bioequivalence studies of highly variable drugs and drug products, as viewed by pharmaceutical industry, academia and regulators. It is anticipated that the outcomes of the Conference will contribute significantly to the harmonisation of regulatory policies. Speakers – and delegates – of the Conference include experts in all relevant fields.

Sessions will include
• Physiological factors affecting drug absorption
• Role of pre-systemic effects on bioavailability
• Impact of variability in BE studies
• Unresolved issues in BA/BE Regulations

Format & Preliminary Programme
Using a similar format to previous EUFEPS conferences, key segments of the process are broken down into a number of sessions, each with lectures and discussions, and general discussion sessions for conclusions and recommendations.

Conference Planning Committee
Co-chairs: Henning H Blume, Oberursel DE; Panos Macheras, Athens GR; Vinod P Shah, North Potomac MD USA; and Achiel Van Peer, Beerse BE
Additional members: Melin Babaoglou, Ankara TR; Daan JA Crommelin, Leiden NL; Hans H Lindén, Stockholm SE; Constantin Mircioiu, Bucharest RO; José A Morais, Lisbon PT; Tomas Salmonson, Uppsala SE; Victor A Voicu, Bucharest RO

Exhibition
Companies are welcome to participate as an exhibitor at this Conference. The Conference delegates are academics, industrialists, regulators and students which will create a unique opportunity to meet experts in your field. The exhibition offers every opportunity to promote and position your company, your products, your services, your expertise and your specialists, facilitating your contact with them, predicting their needs and shaping future collaboration.

Sponsorship Opportunities
To sponsor this Conference and by this enable additional quality meetings on key topics, contact the Executive Director, Hans H Lindén (hans.linden@eufeps.org) or the Project Manager, Annika Nyman (annika.nyman@eufeps.org).

Oral and poster contributions
Scientific contributions relating to the scope and aim of the Conference will be welcome and considered for poster presentations. Abstracts should be submitt-ed to the EUFEPS Secretariat, both as an email attachment and as a hard copy.
Submission deadline is August 30, 2007.

Click for Editorial Instructions.

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

Organisers

EUFEPS was founded in 1991. Its mission 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 there are more than 600 individual members of EUFEPS.

COST, the European cooperation in the field of scientific and technical research, was established in 1971. COST is an intergovernmental European framework for international co-operation and now has 34 member countries and one cooperating state. Rather than funding research itself, COST brings together research teams in the different countries working on specific topics, and supports networking, conferences, short-term scientific exchanges and publications. The Action B25 enables scientists from Academia, Industry and Governmental to interact and transfer knowledge in the area of Physiologically based Pharmaco-Toxicokinetics and Dynamics. For more information on COST and its activities, please visit the COST Website at www.cost.esf.org.

Athens

Preliminary Programme

Monday, October 1, 2007

Welcome, Introduction and Opening Remarks

Daan JA Crommelin, EUFEPS President, Leiden NL
Panos Macheras, Conference Co-Chair, University of Athens, Athens GR

Session I: Physiological Factors affecting Drug Absorption

Session Leaders: José A Morais, University of Lisbon, Lisbon PT & Victor A Voicu, Romanian Academy & University of Medicine and Pharmacy Carol Davila, Bucharest RO

• Complexity of GI physiology and impact on drug absorption
  Clive G Wilson, Strathclyde Institute for Pharmacy and Biomedical Sciences, Glasgow Scotland UK
• Site dependent drug absorption and impact on BA/BE assessment
  Thomas Gramatté, Munich DE and Frank Donath, SocraTec R&D, Oberursel DE
• Impact of food on drug absorption
  Werner Weitschies, University of Greifswald, Greifswald DE
• Formulation effects on drug absorption
  Marcus Brewster, Johnson & Johnson, Beerse BE

Discussion – moderated by: José A Morais, University of Lisbon, Lisbon PT & Victor A Voicu, Romanian Academy & University of Medicine and Pharmacy Carol Davila, Bucharest RO

Session II: Role of Pre-systemic Effects on Bioavailability

Session Leaders: Constantin Mircioiu, University of Medicine and Pharmacy, Bucharest RO & Achiel Van Peer, Johnson & Johnson, Beerse BE

• Integrating the complexities of physiology and biology of GI tract into modelling the interindividual variability of oral drug absorption
  Amin Rostami-Hodjegan, University of Sheffield and Simcyp Ltd, Sheffield UK
• Assessment of intestinal and hepatic first-pass: Necessity to measure metabolites?
  Henning H Blume, SocraTec, Oberursel DE
• Prediction of intestinal first-pass drug metabolism from in vitro data
  Geoffrey T Tucker, University of Sheffield, Sheffield UK
• BCS and BDDCS
  Leslie Z Benet, University of California, San Francisco CA USA

Discussion – moderated by: Constantin Mircioiu, University of Medicine and Pharmacy, Bucharest RO & Achiel Van Peer, Johnson & Johnson, Beerse BE

Demo Get-together: Delegates and Software Developers and Poster Session

Welcome Reception

Tuesday, October 2, 2007

Session III: Impact of variability in BE studies

Session Leaders: Vinod P Shah, International Pharmaceutical Federation (FIP), North Potomac MD USA & Meir Bialer, Hebrew University of Jerusalem, Jerusalem IL

• Within subject variability: Design, determination & demonstration
  Kamal K Midha, University of Saskatchewan and Pharmalytics Inc, Saskatoon CA
• BE design considerations: Multiple dose versus single dose studies
  Achiel Van Peer, Johnson & Johnson, Beerse BE
• Can statistics address the BE for highly variable drugs?
  Panos Macheras, University of Athens, Athens GR
• Current thinking of EMEA position on BE of Highly Variable Drugs
  Tomas Salmonson, Medicinal Products Agency, Uppsala SE
• Current Thinking of FDA on BE of Highly Variable Drugs
  Barbara M Davit, FDA, Rockville MD USA

Discussion – moderated by: Vinod P Shah, International Pharmaceutical Federation (FIP), North Potomac MD USA &
Meir Bialer, Hebrew University of Jerusalem, Jerusalem IL

Session IV: Unresolved issues in BA/BE Regulations

Session Leaders: Henning H Blume, SocraTec, Oberursel DE &
Panos Macheras, University of Athens, Athens GR
Panel Members: George Aislaitner, National Organisation for Medicines, Athens GR, Alfredo García-Arieta, Spanish Agency for Medicines and Health Care Products, Madrid ES & Jan Welink, Medicines Evaluation Board, The Hague NL

Conclusions, recommendations and closing remarks
Panos Macheras, University of Athens, Athens GR

Location
The Conference will take place at the Royal Olympic Hotel, 28-34 Ath. Diakou Str, GR-11743 Athens, Greece,
Tel +30 210 9288400, Fax +30 210 9230331

How to get there
from Athens International Airport ‘Eleftherios Venizelos’:
Board the Metro from the Airport’s Station and get off at ‘Syntagma Station’. At ‘Syntagma Station’, switch lines in the direction of Agios Dimitrios and get off at the first station which is the ‘Acropolis Station’. From the ‘Acropolis Station’ the Hotel Royal Olympic is 100 m away, walking along Ath. Diakou Street. The approximate time from the Athens International Airport to the hotel is approximately 30 minutes at a cost of EUR 10.

Taxi in about 25 minutes at an approximate cost of EUR 30.

Registration
The registration fee (EUFEPS Membership 10% reduction) includes all Conference documentation, all coffee breaks, two lunches and one Welcome Buffet. The cost for hotel accommodation and travel is not included in the registration fee.

Click for online registration

Click for Registration Form (PDF)

Conference Registration Fees

The registration fee will be waived for every second SME delegate from the same SME (Small and Medium-Sized Enterprise, employing fewer than 250 persons), when registering at the same time. This means that you will get two SME delegates per one Industrial Delegate Fee (equalling 50 % reduction). When registering, tick the ”SME Delegate” box, on the Registration Form.

Students
Participants applying for student fees should include proof of their student status (a photocopy of the university identity card).

Confirmation
In order to receive confirmation of registration by email, please make sure to indicate the email address on the registration form! Confirmation will be sent upon receipt of payment.

Alterations
Alterations to your registration must be made in writing and sent to Congrex Sweden AB by email or fax.

Inquiries
Congrex Sweden AB has been contracted for registration and administration support. Please direct all inquiries regarding registration, accommodation or payment to Congrex Sweden AB at: Email bae.registration@congrex.com Phone +46 8 4596600 Fax +46 8 6619125

Hotel Reservation
A number of hotel rooms have been reserved at hotels at preferential rates for the Conference. The hotels are all situated in the city centre of Athens and the Conference venue is accessible with public transportation or by foot.

Click for registration- and hotel reservation form

The rates below are per room, per night and including breakfast.
Hotel accommodation will be reserved and confirmed only when
Congrex Sweden AB has received your credit card number as a guarantee on the registration form. Congrex Sweden AB reserves the right to book another hotel if the desired accommodation should be fully booked. To ensure that the hotel reservation will be made as required, please indicate your credit card number on the registration form. After August 30, accommodation and rates will be confirmed according to availability.

The hotel reserves the right to charge you for all nights reserved and guaranteed on the registration form, should you check out before confirmed departure date or in case of no-show.

All reservations are handled by Congrex Sweden AB. Possible changes of your hotel reservation as well as cancellation must be made in writing to Congrex Sweden AB. Please do not contact the hotel directly.

Payment of Registration Fee and Hotel Accommodation
Please indicate your name and the payment reference number 0791 on all money transfers.

Congrex Sweden AB will not be responsible for identifying funds transferred directly into the account when the name of the participant or invoice number is not mentioned, nor will Congrex Sweden AB accept charges of bank fees associated with the transfer.

Payment should be made in advance by one of the following methods:

• American Express, Visa or Eurocard/Mastercard may be used for all charges. Please indicate card number and expiry date on the registration form.
• Transfer to Handelsbanken, Box 7190, SE-103 88 Stockholm, Sweden, BIC/SWIFT-Code: HANDSESS, Account no. 6137-0434 84239, IBAN No SE24 6000 0000 0000 4348 4239 in EUR to Congrex Sweden AB.
• Scandinavian residents may pay by bank or postal giro transfer. Bank giro 224-7021, or Postal giro 9052-2.

As from 3 weeks before the Conference we only accept credit card as payment. Registrations will be confirmed when Congrex Sweden AB has received payment. Admission to the Conference is granted only if Congrex Sweden AB has received the registration fee. Delegates, who have made late payments, should bring a proof of payment to the Conference. Failure to produce this on request gives Congrex Sweden AB the right to charge the amount to your credit card.

Cancellation of Registration
Notification of cancellation must be made in writing and sent to Congrex Sweden AB. Cancellation of registration will be accepted until August 30, 2007, up to which date the total amount will be refunded less EUR 50 for administrative expenses. For cancellations made after August 30, 2007 we regret that no refunds can be made.

Cancellation of Hotel Reservation
Notification of cancellation must be made in writing and sent to
Congrex Sweden AB. Cancellation of any hotel reservation will be accepted until August 30, 2007, up to which date the hotel deposit will be refunded less an administration fee of EUR 50. We regret that after August 30, 2007, we will charge you for the whole stay.

General Information
Badges
Each participant will receive a name badge upon registration. For security reasons all participants are requested to wear their name badge during all the Conference activities.

Currency
The currency in Athens is EUR.

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

The Congrex Group works internationally with subsidiaries in the Netherlands, the United States and Sweden as well as licensed partners throughout Europe and Latin America.

Useful Addresses

Additional Information
For more information, see e.g. circulating announcements and updates on this website, on the COST Action B25 Website at
www.cost.esf.org/index.php?id=212&action_number=B25
or on the Congresses and Conference Section of the FIP Website at www.fip.org

Alternatively, contact
EUFEPS Meetings and Events
PO Box 1136
SE-111 81 Stockholm
Sweden
Tel +46 8 7235000
Fax +46 8 4113217
Email conferences@eufeps.org