What Is a Development Safety Update Report (DSUR)?
A Development Safety Update Report (DSUR) is a formal safety report that is prepared by the pharmaceutical companies at the clinical development stage of an investigational medicinal product (IMP). It is aimed at ensuring that participant safety is maintained by giving an overall annual review of all available safety information to regulatory authorities.
What Is a Dossier Submission?
Dossier Submission is a systematized procedure for gathering and submitting documentations to legal bodies to seek authorization of pharmaceuticals, medical devices, or healthcare items. Such dossiers show that a product has attained the necessary standards of quality, safety, and efficacy prior to becoming marketed or distributed in a particular country or region.
What Is the Drug Information Association (DIA)?
A worldwide nonprofit organization, the Drug Information Association (DIA) is committed to improving healthcare by fostering collaboration and knowledge sharing among experts in the creation, regulation, and lifecycle management of pharmaceuticals and medical products.
What Is Drug Safety?
Drug safety or pharmacovigilance is the field and practice of identifying, evaluating, interpreting, and averting the negative effects or any other issues regarding drugs. Its main aim is to guarantee that drugs are safe in the lifecycle of their patient use that is, both in clinical development and in post-marketing use.
What is NextGen ESG?
In the current dynamic regulatory and sustainability environment, NextGen ESG is a clear breakthrough in the way companies approach, report, and optimize their environmental, social, and governance (ESG) practices.