Medical and Regulatory Affairs

Medical and Regulatory Affairs (MRA) is an integrated team composed of central units (Central Medical and Central Regulatory, located in Harefield) and country based staff. Teams in larger countries report directly into the head of MRA in France, Germany and the UK. Staff in smaller countries form an Established and Emerging MRA team who also report into the head of MRA. Medical and Regulatory staff are based in all of Norgine’s key countries whereas Medical and Regulatory liaison through partners and distributors is provided by the Central Medical and Central Regulatory groups.

It is essential for MRA in Norgine to act as a coordinated team which thinks globally and acts locally.

The main activities undertaken are Medical Information, input into Marketing activities and customer liaison. In addition MRA are responsible for non-interventional trials on marketed products.  MRA also provides the infrastructure to many elements of the country network for Global Pharmacovigilance and Product Quality. Country staff manage the receipt and processing of adverse event reports, Product Quality Complaints, requests for medical information from consumers, sales representatives and healthcare professionals. They perform local literature scanning and review for identification of adverse events and Special Situations.. They also work closely with Commercial teams to liaise with our customers and external experts. The Central Units ensure all actions are coordinated in a coherent, harmonised and holistic manner.

The Central Regulatory group covers the whole range of products and activities, predominantly for marketed products.  They provide regulatory support from development to submission and beyond, including line extensions and new indications. 

The Medical Writing and Data Management team is responsible for generating documents such as the clinical trial protocol and the clinical study report. In addition they oversee the collection and processing of data and generate documents summarising all studies that have been performed with each compound, such as safety reports, and the clinical overviews required for first registration.  Finally, this team is responsible for ensuring that details of all clinical trials conducted by Norgine appear on regulated databases available to the public, and where appropriate, that any data generated are available in the public domain.