5.1 Introduction Once a medicinal product has been approved for marketing, the marketing authorization holder (MAH) has an obligation to periodically submit a number of pharmacovigilance reports to relevant regulatory…
3.1 Introduction The process of pre-authorization clinical development is considered complete when the sponsor has collated sufficient evidence of efficacy and safety for the investigated medicinal product. Thereafter, it is…
4.1 Introduction The pharmacovigilance documents associated with risk evaluation and management are often required components of Marketing Authorization Application (MAA) and New Drug Application (NDA) submissions, and thus could have…
6.1 Introduction In addition to the multiplicity of mandated periodic pharmacovigilance documents required for investigational and authorized medicinal products, documents submitted at the time of application for marketing authorization, and…
2.1 Introduction When a company or academic institution is granted permission to test a yet to be authorized medicinal product on human subjects (or an authorized medicinal product in a…
7.1 Introduction For obvious reasons, the main preoccupation of this volume has been to focus on pharmacovigilance medical writing as it is practiced in the EU and US. It would…
In the first instance, the clinical development phase is associated with annual submissions of the Development Safety Update Report (DSUR) in the European Union (EU) and the Investigational New Drug…
