Let DRA to take the responsibility for pharmacovigilance of your pharmaceutical products. We can provide full PV services tailored to your needs, including an EU Qualified Person for Pharmacovigilance (QPPV or deputy QPPV), as well as any PV support services for the Nordic countries.
Our pharmacovigilance services include:
- Pharmacovigilance specialists and/or trained experts for QPPV roles and PV training
- Local PV support in the Nordic countries
- Preparation and maintenance of Pharmacovigilance System Master File (PSMF)
- Continuous benefit-risk analysis, including signal management and Periodic Safety Update Reports (PSURs),
- Risk management of medicinal product, including authoring and updating Risk Management Plans (RMPs) and implementation of additional risk management measures
- PV quality management and writing Standard Operating Procedures (SOPs)
DRA’s trained experts will perform high quality PV activities to guarantee that your pharmaceutical products meet all regulations and requirements according to legislation. Our services include drug safety monitoring, reporting and safety risk management activities, and our team can also take care of care of preparing documentation for you, like Periodic Safety Update Reports (PSURs). Rest assured that when we monitor the safety of your medicinal products, we will respond immediately if any potential safety issues are identified.
Biological medicines: how does their manufacturing process differ from traditional medicines?
The differences in the manufacturing process and the nature of the active substance itself mean that biologicals differ from traditional medicines in many ways.
EU Council to postpone the MDR deadlines
The commission’s plan would not automatically apply an extended transitional period for all the medical devices, but the extension would be allowed on the condition that it is critical for the safety of the patients.