Regulatory Agency
We recognise that Regulatory Agencies have the capability to review all the clinical data they receive, such as applications for marketing authorisation or clinical trials. However, there may be times when capacity is not sufficient to meet demands, perhaps due to a surge in applications, or possibly due to reductions in workforce.
If you work for a regulatory agency and need extra medical support to assess applications or patient safety data, read on to find out how we can help.
Why would you need our support?
There seems to have been an exponential rise in the amount of innovation in general, and in particular in the pharmaceutical and devices industry. Patients and prescribers are demanding access to these technologies, which means Regulatory Agencies need to work hard to reduce the time it takes to approve novel interventions. At the same time there is a need to reduce costs for healthcare systems by providing access to the multitude of generic and biosimilar products now becoming available.
Regulatory Agencies are constantly exploring innovative ways to meet the increasing demands on their time, and have had some excellent ideas, such as providing Applicant Assessment Aids or utilising AI-based tools to support their reviews of applications for marketing authorisation or clinical trials. But these do not replace regulatory oversight and there will still be occasions where extra support is needed for medical reviews.
Why choose Pharmora?
As an independent organisation with clinical development and patient safety expertise, which has helped applicants with countless submissions for marketing authorisations, Pharmora found itself perfectly positioned to support Regulatory Agencies in reviewing such applications and safety data.
We have experience in supporting the review of multiple different types of marketing authorisation applications, including new indications, well established use applications and Type II variations, on behalf of the Regulatory Agency.
We are also experienced in reviewing risk management plans and safety data, and conducting signal evaluations.
The contracting process
Following initial contact from a Regulatory Agency we will sign a confidentiality agreement and then hold a meeting to discuss the scope of the project. The Chief Medical Officer or Deputy will attend this call, along with the relevant people who will be drafting the contract, to ensure we ask the right questions to populate the document.
Pharmora will then draft a Scope of Work document and send a proposal for review. Once agreed by all parties, the contract will be signed, and we will pass the work to the Pharmora Medical Department to deliver.
Depending on the requirements of the particular Agency department Pharmora will assign a suitable team of highly trained individuals with expertise in that area to review the data and generate appropriate documentation.
This can all be achieved very quickly. The speed is generally determined by the time taken by the Agency to review and sign the documentation.
Working with Pharmora
A conflict of interest (COI) process firstly takes place, where the Agency provides the name of the Applicant / Licence Holder and we check if Pharmora is working (or has ever worked) for them. If we have no COI we will confirm this right away and can begin work as soon as the documentation is uploaded.
Integrity is our foundation value. If anyone in Pharmora is in doubt (e.g. Pharmora supported one study from the Applicant but for a different product) we will discuss this with the Agency to ensure complete transparency, and offer to swap that project for a different one if there is any concern.
Where a template exists Pharmora will use the template as advised by the Agency. Alternatively, we can generate a proposed template for Agency approval if requested.
The Agency will upload documents to a secure sharing area and give specified members of the Pharmora team access to this area.
Pharmora will create a document based on the template agreed with the Agency, and begin to populate it with data from the documents uploaded in the secure shared area. We will then add comments and propose questions for the Agency to consider.
Once completed Pharmora will upload the document to the secure shared area and send a link to the Agency contact person. No data will be sent via email. If there are several documents for a specific Agency we use a tracking system (e.g. a spreadsheet in the shared area) to indicate which documents are under review, any issues we have identified along with our proposed position, and provide an estimated completion date.
Pharmora welcome feedback and will be happy to meet as often as requested during the review of documentation, to discuss our findings and gather feedback on our proposed approach.
Contact us for an informal discussion to find out how we can help you.
