Pharmacovigilance

We help establishing and maintaining pharmacovigilance systems that meet all the legal requirements. And what’s more: Diapharm can even act as your QPPV!

Pharmacovigilance systems

We offer he necessary support for:

• Evaluation of existing pharmacovigilance systems (SOPs, literature research, reporting, PSURs, alarm plans, etc.) and measures to minimise risk
• Establishing pharmacovigilance systems and compilation of risk management plans (RMP) that are based on standardised procedures for human and veterinary medicinal products
• Individualised implementation into the company, employee training
• Conducting internal audits
• Preparation for and assistance with inspections by regulatory authorities

By the way: A detailed description of the pharmacovigilance system (DDPS) and risk management plans are necessary parts of most applications for marketing authorisations. Diapharm helps compile the required documents.

Qualified Person for Pharmacovigilance

All pharmaceutical companies need one: the Qualified Person for Pharmacovigilance (QPPV) is obliged to run the pharmacovigilance system for pharmaceutical manufacturers whose products are sold commercially. He or she has to collect and evaluate reports on drug risks and coordinate any necessary actions, and even more. To do this, the QPPV must be available 24/7, 365 days a year.

Diapharm is the perfect partner for pharmaceutical companies that wish to outsource this position. We act in this capacity for pharmaceutical companies, relieving them of the associated time, effort and expense

For more information visit www.diapharm.com