• "Drugs of this class are reported to cause..., but no reports have been received to date with Drug X.".  In these situations, the ADR should not be considered as expected for Drug X. In the absence of sufficient documentation and in the face of uncertainty, a reaction should be regarded as unexpected. 2.4 Other Definitions 2.4.1 Healthcare Professionals Healthcare professionals are medically-qualified persons such as physicians, dentists, pharmacists, nurses, coroners, or as otherwise specified by local regulations.
Médicaments et produits de santé Imprimer | Besoin d'un texte plus grand? nom du contact Heather Sutcliffe Et aussi disponible en format PDF [e2d_step2_etape2-eng.pdf] pages : 15, taille : 225 K, date : 2003-09-16 le 16 septembre 2003 AVIS Notre référence: 03-117599-513 Publication de l'ébauche (étape 2) de la ligne directrice l'ICH1: