Specialist Support Outsourcing

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”?

We can help interpret the questions

Since our consultants have served extensively as regulators themselves they can help you to better understand the type of information and response the regulatory authorities need. Our staff and consultants include those who have been members of the committees which created much of the original drug safety legislation. Understanding the legislation and responding with exactly what is required saves you time, substantial costs and a tremendous amount of unnecessary effort.

We can identify the necessary resources for the response

Our consultants can pinpoint the correct next step for you – whether that means advising on the precise resources needed to respond to an issue that is subject to legislation, to advise on the pharmacovigilance services that are required or the data, literature searches, etc. There are many areas that you could need to focus on – a clear vision of what to present to the authorities means your response is faster, more accurate and more appropriate.

We can develop your strategy

Experience on the regulatory bodies means our people know not only the type of response you need to give but also what monitoring, changes to Marketing Authorisations or other actions that may be appropriate. We can contribute to, write or review and comment on the response document. PrimeVigilance consultants can help companies prepare with pre-hearing rehearsals, or attend and support during oral representations with the regulators. Regulators need coherent responses, not ‘stock scripted answers’, but rather an understanding of what it is they are asking that results in a meaningful response.

Inadequate responses can result in unnecessary damage to products and significant expense to the company and the reverberations can result in a vicious cycle of continuing questions and responses.

But prevention is better than cure and early identification of potential safety concerns and their effective management, assisted by PrimeVigilance consultants, may help to pre-empt the regulators’ questions. And we can help you put in place the necessary crisis management procedures just in case those difficult questions do arise.

Regulatory Authority interactions: Compliant and coherent
Just one of the pharmacovigilance services from PrimeVigilance

For more information contact PrimeVigilance today

Brown EG Methods and Pitfalls in Searching Drug Safety Databases Utilising the Medical Dictionary for Regulatory Activities (MedDRA). Leading article. Drug Safety 2003, 26(3):145-58.

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