When it comes to drug safety, Diapharm is a reliable partner to the pharmaceutical industry. We take care of everything – from preparing PSURs to developing complete pharmacovigilance systems.
Developing of a pharmacovigilance system and compiling the necessary risk management plans and SOPs can tie up capacities at pharmaceutical companies. The Summary of this Pharmacovigilance System Master File (Summary-PSMF) is a necessary requirement to gain a marketing authorisation. Diapharm provides solutions to make pharmacovigilance safe, yet easier for companies. We help audit internal drug safety procedures, draft SOPs and can provide appropriate risk management plans and complete pharmacovigilance systems if needed.
Diapharm monitors the safety of medicinal products for many companies. Depending on a company’s needs, we can provide individual services – such as evaluating and reporting adverse drug reactions (ADRs) and severe adverse effects (SAEs) as required by law – or a complete pharmacovigliance package.
We offer pharmaceutical companies signal management services and ongoing risk/benefit analysis and assessment to ensure the constant, quality-assured and convenient monitoring of medicinal products.
On behalf of clients, we will handle electronic procedures for reporting suspected adverse drug reactions (ADRs) to the EudraVigilance database. Suspected cases must be reported to the EMA database within a time frame of 15 days for serious ADRs and 90 days for non-serious ADRs.
For clients, we also monitor the EudraVigilance database for ADR reports from the market, meaning suspected cases reported by patients and healthcare professionals to national agencies. We offer pharmaceutical companies signal management services and ongoing risk/benefit analysis and assessment to ensure the constant, quality-assured and convenient monitoring of medicinal products.
The qualified person for pharmacovigilance (QPPV) is responsible for establishing and maintaining a company’s pharmacovigilance system. However, the strict formal requirements for this position present many companies with a challenge. After all, the person in charge of pharmacovigilance has to be available 24/7 – and companies must designate an acting QPPV in the event of leave or illness.
Diapharm is there to help: We provide a local QPPV (also known as Graduated Plan Officer) for pharmaceutical companies and take care of all their pharmacovigliance duties. Contact us!