International Congress on Ethics in Bio-Medical Research
Venue: Palais du Luxembourg, Salle Clémenceau, Paris, France, 11-12 April 1997
For further information please contact:
FIP Congresses & Conferences, Andries Bickerweg 5, 2517 JP The Hague, The Netherlands
Tel: +31-70-3631925 Fax: +31-70-3659047
Email m.swakhoven@fip.nl
Conference Programme
Friday, 11 April 1997
08.00-08.55 Registration and Identity Control
08.55-09.00 Opening D. Steinbach, PhD, FIP President, FRG
Session I: Basic Concepts of Bio-Medical Research and Ethics
09.00-09.20 Obligations in medical research
09.20-09.50 Obligations in industrial research
- Pharmacotherapy
- Medical devices
09.50-10.10 Ethics in scientific research
10.10-10.30 Ethics in bio-medical research
10.30-10.50 Relationship ethics research: American approach
10.40-11.00 Internationalisation of industrial constraints
11.15 Break
11.30-12.30 Round table discussion
12.30-14.30 Lunch in the Palais du Luxembourg (included in the registration fee)
Session II: Subjects Implication
14.30-14.50 Responsibility of the physicians
14.50-15.10 Federal Administrative Organisation FDA regulation
15.10-15.50 Consent of the subjects
- Freedom of the consent
- The example of cancerology
15.50-16.30 Protection of the subjects
- The French legislation
- The European harmonisation
16.30-17.00 Break
17.00-18.00 Round table discussion
Saturday, 12 April 1997
Session III: Innovative Therapies
09.00-09.20 The scientific up-dated situations
09.20-09.40 The challenge of medical devices
09.40-10.00 The international harmonisation endeavour
10.00-10.30 Transposition from ethic obligations to industrial constraints: the FDA point of view
10.30-10.40 Break
Session IV: Political Implications
10.40-11.00 The role of the World Health Organisation
11.00-11.20 The role of UNESCO
11.20-11.40 The situation in Japan
11.40-12.00 The state of the art in European Community
12.00-12.20 The French policy
12.30-13.00 Conclusions of the Congress
13.00 Lunch in the Palais du Luxembourg (included in the registration fee)
Approached Lecturers
- Pr ALEXANDRE, International Conference on Harmonisation, (F)
- Pr CANO, Ministère de la Santé, (F)
- Pr CROMMELIN, University of Utrecht, (NL)
- Dr FLUSS, WHO, (CH)
- Pr GUENIOT, Académie de Médecine, (F)
- Pr. GRISCELLI, INSERM, (F)
- Pr HEIKKINA, WHO, (CH)
- Pr HERVÉ, Université Paris V, (F)
- Pr HURIET, Sénat, (F)
- Dr LENOIR, UNESCO, (F)
- Dr LEUPRECHT, Conseil de l'Europe, (EC)
- Dr MANGEOT, Lab. Glaxo-Wellcome. (UK)
- Pr THOUVENIN, Université Paris VII, (F)
- Pr TURSZ, IGR, (F)
- Dr WELLS, ABPI, (UK)
- Dr ZOON, CBER, Food and Drug Administration (USA)
General Information
Venue: The Conference will take place at the Palais du Luxembourg, Salle Clémenceau, Paris, France
Registration and Identity Control: Friday, 11 April 08.00 h (Passport - Identity Card)
Languages: The official languages are English and French. Simultaneous interpretation from and into these languages will be provided.
Insurance:
It is strongly recommended that participants take out insurance to cover their visit. The congress and its organisers cannot be held responsible for any loss or damage.
Visa
Participants are responsible for procuring a visa if necessary for attendance. Please contact your French Embassy.
Daily identity control (passport - identity card) will be organised (11-12 April).
Fees in Dutch Guilders:
Fl. 1.100,- (including a welcome party on Friday, coffee and tea breaks and lunch on Friday).
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