an introduction to regulatory affairs for qps
Medicinal products regulatory affairs is an activity that must be performed by all marketing authorisation holders (MAHs) throughout the lifecycle of the medicinal product or products for which they hold a product licence in order to maintain the licences for their products in compliance with current medicinal products legislation and guidance. Specifically, regulatory affairs is the oversight of company compliance with regulations and laws pertaining to the manufacture, marketing and development of medicinal products.
Given that the Qualified Person must certify that all batches are manufactured in accordance with the Marketing Authorisation, the qualified person (QP) and other key staff in a licensed manufacturing facility should have a full and complete understanding of the regulatory requirements for the products for which they are responsible and the implications of such requirements on their day to day activities. This course aims to bridge the gap between the activities of the QP and the application for and maintenance of individual products licences.
The course will be delivered over a period of two days. Day 1 will include a basic introduction to the regulatory requirements for medicinal products and the processes and procedures for obtaining a medicinal product licence.
On Day 2 in the morning the focus will be on the post-marketing activities once a medicinal product has a product licence in order to ensure ongoing compliance with the regulatory requirements throughout the life cycle of the medicinal product. Day 2 in the afternoon there will be a work shop session on the real life implications of regulatory affairs activities on routine manufacturing activities and vice versa.
event date: tbc
individual price: €1,000 per person
location: The Maldron Newlands Cross