Disclosure on Management Approach: Product Responsibility
Organisation
Pharmacovigilance is the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. At Novo Nordisk, the chief responsibility for pharmacovigilance within the company is undertaken by International Product Safety (IPS), whose responsibilities include involvement in any emerging drug safety-related concern; provision to authorities of safety information; and review of safety reports, new safety information and complaints. The vice president of IPS reports to the senior vice president of Quality. IPS is organised according to three key processes:
- Customer complaint handling
- Safety case handling
- Safety surveillance.
In order to be in compliance with procedures for handling adverse events and safety information, Novo Nordisk has several Safety Committees that review safety of specific products. In order to protect the safety of clinical trial participants, Novo Nordisk may initiate external independent Data Monitoring Committees.
The global regulatory affairs function obtains and maintains the market authorisations for all products and is responsible for all product labelling.
Goals
Ensuring patient safety is one of the most important commitments a pharmaceutical company makes in the delivery of its products and devices. It is also an aspect of company activities which is highly regulated. Novo Nordisk has long had policies and processes and a comprehensive Quality system in place to minimise any safety risks connected with the use of its products and devices. The Quality Mindset is one of the fundamental management principles in the Novo Nordisk Way of Management: “Everyone must continuously improve the quality of their work.”
Policy
Novo Nordisk has long had policies and processes and a comprehensive Quality system in place to minimise any safety risks connected with the use of the company’s products and devices. It is our policy to take early contact with authorities and to be proactive in addressing any safety issues that arise. We strive to be open and transparent in our communication about the safety of our products. In adhering to high standards in both the manufacturing of products and their safe use by patients, Novo Nordisk is overall in high compliance with regulatory demands, as reflected by the outcomes of recent inspections.
Novo Nordisk subscribes to the WHO Ethical Criteria for Medicinal Drug Promotion. Furthermore, the company’s policies and procedures are in accordance with the principles of industry codes of practices, such as the PhRMA, EFPIA, IFPMA, JPMA marketing codes. Novo Nordisk does not have specific policies regarding consumer privacy.
Monitoring
Novo Nordisk has procedures, systems and processes in place to ensure that safety information on all serious adverse events is entered into a global Novo Nordisk safety database. This activity comes under the broad heading of pharmacovigilance.
Pharmacovigilance is the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. At Novo Nordisk, the chief responsibility for pharmacovigilance within the company is undertaken by International Product Safety (IPS), whose responsibilities include involvement in any emerging drug safety-related concern; provision to authorities of safety information which may influence the benefit-risk ratio evaluation of a product; and review of safety reports, new safety information and complaints.
This work is supported by hundreds of people throughout the Novo Nordisk organisation. Subsidiaries in the local markets are required to report serious adverse events within 48 hours and non-serious adverse events on a weekly basis, unless otherwise agreed.
IPS is organised according to three key processes:
- Customer complaint handling
- Safety case handling
- Safety surveillance.
The vice president of IPS reports to the senior vice president of Quality.
Information about adverse events can come from a range of sources, including spontaneous reports from healthcare professionals and patients; post-marketing or observational studies; investigators who submit reports about ongoing clinical studies; regulatory authorities; medical and scientific literature; and the media. All such information is entered into the Novo Nordisk global safety database. The information is used to analyse, monitor and report on the safety of all our products to regulatory authorities.
Safety Committees
In order to be in compliance with procedures for handling adverse events and safety information, Novo Nordisk has several Safety Committees that review safety of specific products. For marketed products, members consist of representatives from the relevant safety surveillance department, global development, marketing and regulatory affairs, with ad hoc attendance from other relevant areas.
These are responsible for reviewing:
- The results of non-clinical studies in pre-clinical development
- The results of ongoing safety surveillance managed by IPS on Novo Nordisk’s products and devices
- Any safety concern that has come to the attention of any Novo Nordisk employee and which has been reported to IPS.
The Safety Committee is the sole Novo Nordisk body responsible for initiating appropriate actions in the event of a safety signal or alert.
Data monitoring committees
In order to protect the safety of clinical trial participants, Novo Nordisk may initiate external independent Data Monitoring Committees. These are formed to independently review and evaluate accumulating safety data from an ongoing clinical trial. Such committees may be warranted in clinical trials investigating high morbidity and/or high mortality trial populations, particularly in vulnerable populations or in long-term exposure clinical trials.
Clinical risk management plans
Another important feature of the Novo Nordisk system for ensuring safety of our products for patients is the Clinical Risk Management Plan. This plan identifies the potential risks associated with a medical product, methods to further clarify the safety profile of a product, and ways to minimise risk and achieve an improved benefit-risk ratio for individual patients in clinical use.
To enhance transparency of information to physicians and patients about the safety profile of products in clinical trials as well as marketed products, data from Novo Nordisk’s clinical trials are available at a dedicated website.
In addition to Novo Nordisk’s own monitoring activities, the company is subject to regular external audits by regulatory bodies such as the US Food and Drugs Administration to ensure that all aspects of quality are being managed appropriately.
