Belgium

Exploratory Clinical Trials Meeting

3 June 2008

The Belgian Chapter held an Exploratory Clinical Trials meeting. Please find below the presentations and speakers that participated in this conference.

Speaker Presentations:

• Biomarker Validation or Phase 0 (.pdf)
  Dr. David Sciberras, Amgen
  
  
• Exploratory CTAs in Belgium (.pdf)
  Dr. Walter Janssens, FAGG

ACRP Belgian Chapter’s 10th National Conference: Late Breaking Clinical Trial News

21 September 2007

The Belgian Chapter held its 10th National Conference at ULB-Hopital Erasme in Brussels on 21 September 2007. Please find below the presentation and speakers that participated in this conference.

Speaker Presentations

• Clinical Trials Recruitment of Patients (.pdf)
  Dr. Paul Beke (Orde van Geneesheren)

• Patient Recruitment and Retention (.pdf)
  Prof. P.P. De Deyn (Commissie Med Ethiek, Middelheim)

• Revision of the Medical Device Directives & Clinical Evaluation (.pdf)
  Dr. Isabelle Demade (Cosmetics and Medical Devices, Directorate F-Consumer Goods)

• Managing Timelines in Patient Recruitment (.pdf)
  Drs. Clara Heering (Pfizer)

• EMEA’s First in Man Clinical Trials Guideline and the New Belgian Guidelines on Exploratory CTA (.pdf)
  Prof. Jan de Hoon (Center for Clinical Pharmacology, UZ Leuven)

• The European Paediatric Regulation: Current Situation (.pdf)
  Dr. Christophe Lahorte (FAGG, R&D)

• Re-inventing Clinical Research: Introduction to AD/SAD (.pdf)
  Dr. Yves Geysels (Novartis)

• ISO 14155 (.pdf)
  Aly Talen (genae associates)

Current Legal Risks and Liabilities in Clinical Research and Pharmacovigilance

28 November 2006

Speaker Presentations

• Introduction (.pdf)
  Emmanuel Collin
  
  
• Current Legal Risks and Liabilities in Pharmacovigilance and Clinical Research (.pdf)
  Maurits Lugard

8th Annual National Conference in Collaboration with ARESA: Late Breaking Clinical Trial News

18 November 2005

Speaker Presentations

• Welcome and Opening (.pdf)
  Dr. Y. Geysels
  
  
• Importance of Phase 1 Studies for Belgium (.pdf)
  Omer Van Schoor
  
  
• Medical device regulation (.pdf)
  Dr. Veerle Verlinden
  
  
• Transportation of infectious substances and diagnostic specimens (IATA regulation) (.pdf)
  Jean-Guy de Gruben
  
  
• Some thoughts about efficacy and effectiveness studies (.pdf)
  Prof. emeritus Marc Bogaert
  
  
• Legal aspects of e-CRF in Belgium: drawing lessons from experiences (.pdf)
  Benoit de Nayer

First Experiences with EMEA Inspections in Belgium

19 April 2005

Speaker Presentation (requires password)

• EMEA Inspections (.pdf)
  K. Van de Voorde

ACRP Belgium National Conference Law Concerning Experiments on the Human Person

29 October 2004

Speaker Handouts (requires password)

• The Ethics Committees and the Belgian Law (.pdf)
  M. Bogaert
  
  
• Investigator Sponsored Studies (.pdf)
  L. Dewulf
  
  
• Pharmacovigilance: How to report safety issues? (.pdf)
  M. Gabriëls
  
  
• The Role of the Competent Authorities (.pdf)
  G. Musch
  
  
• The law concerning experiments on the human person (.pdf)
  C. Trouet
  
  
• Clinical Trial Applications under the new Law: How to standardise EC submissions (.pdf)
  P. Winderickx

Contact Information

President
Yves Geysels, PhD
N.V. Novartis Pharma S.A
+32 2 246 1669
Email: BelgiumChapter@acrpnet.org

Treasurer
Griet Bauwens
Novartis

Secretary
Peter Burggraeve
Pandora

Peter Paul De Deyn, MD, PhD
UIA

Robert Lins, MD, PhD
SGS

Monique Podoor, MD
Pharmacon, Consultant

Daniel Schuermans
UZ-VUB

Herbert Spapen, MD, PhD
UZ-VUB

Aly Talen
genae associates nv

Benedict Van Nieuwenhove, MD, PhD
Harrison C.R, Consultant

Blanche Selby
ACRP Administrator
European Office (London)
Goswell House
134 Peascod Street
Windsor
Berkshire, SL4 1DS, UK
Tel: +44 (0) 1753 831 900
Fax: +44 (0) 1753 855 157
E-mail: EURoffice@acrpnet.org