Archiving – How long?
EMA/15975/2016 (“Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of …
ACPS News
Bioequivalence-Testing
Authorization of multi-origin (generic) drugs is based on the argument of equivalence vs. the originator. To this purpose. clinical therapeutic equivalence studies …
CT-Pharmacovigilance Manual
Pharmacovigilance (PV) of authorised medicinal products is regulated by a series of regulations, directives, laws and guidelines. These rulings do not relate …
Trial Management – Lost in delegation?
Clinical trials call upon a complex network of resources i.e. parties contracted by the sponsor and parties subcontracted by such delegates (e.g. …