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USEFUL LINKS

Ethical Committees

  • BAREC member committees
  • Clinical Trial College (FOD Volksgezondheid, Veiligheid van de voedselketen en Leefmilieu)

Consensus

  • ICH International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

  • GCP Guidelines for Good Clinical Practice E6(R1)

  • WMA Declaration of Helsinki

  • Déclaration d’Helsinki de L’AMM

Hospitals

  • Association Belge des Hôpitaux

  • Belgische Vereniging der Ziekenhuizen

  • Conférence des hôpitaux académiques (CHAB)

  • Raad van de Universitaire Ziekenhuizen van België (RUZB)

Belgian Competent Authority

  • FOD Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu

  • SPF Santé publique, Sécurité de la Chaîne alimentaire et Environnement

  • FAGG Federaal Agentschap voor Geneesmiddelen en gezondheidsproducten

  • AFMPS Agence Fédérale des Médicaments et produits de Santé

EMA

  • European Medicines Agency – EMA

  • EU Legislation – Eudralex

  • EudraCT

  • FDA Food and Drug Administration

Regulation & Law

  • European Commission : Clinical trials

  • Clinical Trials Regulation (CTR) EU No 536/2014

  • Règlement (UE) essai clinique No 536/2014

  • Verordeningen (EU) klinische proeven Nr 536/2014

  • Belgisch Staablad – Moniteur Belge

  • Législation belge – Justel

  • FAGG – Wetgeving

  • AFMPS – Législation

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