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Specialist support outsourcing

Risk Management Plan (RMP)

Following the release of GVP Module V, all applications for marketing authorisation in the EU must now include a detailed and complex Risk Management Plan (RMP). In addition, renewals for generic products may require an abbreviated RMP. This requirement depends on the nature of the product and may not be necessary in all circumstances and our expert medical writers and Pharmacovigilance risk benefit specialists can advise both on the need for an abbreviated RMP and on its content. PrimeVigilance can help our clients determine identified and potential risks for both detailed and abbreviated RMPs.

Responding to regulator safety enquiries

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”?

Assessment of benefit-risk

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...

Safety concerns and Safety communication

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...

Data Safety Monitoring Boards

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.

Pharmacovigilance Process Development

The Good Pharmacovigilance Practice (GVP) Guidelines 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...