All applications for marketing authorisation in the EU must include a detailed and complex Risk Management Plan (RMP). In addition, renewals for older or generic products require an RMP.
When regulatory authorities have questions about the safety of your products or about the effectiveness of your pharmacovigilance system, you had better be able to come up with the answers. And who better to help with the response than PrimeVigilance experts and pharmacovigilance consultants who have “sat on the other side of the table”?
The EU regulations and Guideline on Good Pharmacovigilance Practices require companies to continuously monitor the benefits and risks of their marketed medicines. This involves various activities requiring pharmacovigilance experience and expertise including:
Reports of issues regarding the safety of your medicinal products may come in from many different sources. Most pharmacovigilance professionals expect spontaneous reports to come in from GPs and regulatory authority but there are other sources:
A Data Safety Monitoring Board, or Data Monitoring Committee (the terms are used interchangeably), is a committee used to monitor safety in clinical trials. They enable safety monitoring to be carried out while maintaining the blinding of the trial so that the blinding is not broken and the trial remains valid.
The Good Pharmacovigilance Practice (GVP) modules and other drug safety regulations set out exacting standards for you to meet without exception and the quality documentation required for your systems and activities is extensive and specified in GVP Module I. Due to the level of complexity, most companies find they face challenges e.g.:
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