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 Markets report directly into the head of MRA in France, Germany and the UK. Staff in smaller Markets form an Established and Emerging Markets MRA team which reports into the head of MRA. Medical and Regulatory staff are based in all of Norgine’s key Markets. Medical and Regulatory liaison through partners and distributors is provided by the Central Medical and Central Regulatory groups.
The ethos of the MRA in Norgine is to act as a coordinated team which thinks globally and acts locally.
The main activities undertaken by the Central Medical team are Medical Information, input into Marketing activities and customer liaison. In addition MRA are responsible for non-interventional trials on marketed products. The Central Regulatory Affairs (CRA) group is responsible for a wide range of activities. These include maintenance of Company core data sheets (CCDS) publishing as well as managing partnerships and distributor markets. The CRA group also provides support for the whole range of products and regulatory life cycle activities, predominantly for marketed products. In addition MRA provides the infrastructure to many elements of the country network for Global Pharmacovigilance and Product Quality liaison. 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, key opinion leaders and external experts. The Central Units ensure all actions are coordinated in a coherent, harmonised and holistic manner.
The Medical Writing and Data Management team is responsible for generating documents such as clinical trial protocols, investigators’ brochures and clinical study reports. 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. This group is also responsible for writing responses to clinical questions received from Regulatory Authorities, and for providing support for the Company Core Datasheet across the Norgine portfolio. 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.