The regulatory requirment is essantial for placing and maintaining a medicinal product on the market but it is becoming more and more complex. For a successful marketing and management of the life cycle of a medicinal product it is an essential to have a detailed knowledge of the regulatory framework and to be completely up-to-date with its constantly changing regulations. This guide for Knowledge of “ Requirment of Drug Regulatory Affairs” was designed as a Platform for everyday practice, which should make routine work easier, and also keeps the user well informed about changes in the legal andm regulatory environment.
The guide will help the regulatory affairs professionals to be aware of the “regulatory jungle”, make easy work in this area and make it more competent.
v Different procedures for drug approval, and relevant legislation and requirements to be considered when submitting an application for Marketing Authorisation
v Application for Marketing Authorisation and the accompanying documents which demonstrate quality, safety and efficacy.
v Marketing Authorisation for Special Drug Products
No comments:
Post a Comment