• When regulatory authorities question the safety of your products or about effectiveness of your pharmacovigilance system, our team of consultants can help to interpret the queries, identify necessary resources for the response and develop the right strategy.
  • FHS consultants can help companies prepare with pre-hearing rehearsals or attend and support during oral representations with the regulators.
  • Safety Data Exchange Agreements (SDEA) governs the inbound flow and management of the safety information and they are a legal requirement in all cases where safety data might be received by any third party that is not the license holder.
  • The types of safety data received can be very varied, they can be reports of adverse events but equally they can be other safety data: reports of abuse, misuse, overdose, medication error, use in pregnancy, lack of efficacy – and others.
  • The MAH must have a system in place to receive these reports, the 3rd party must have processes in place to transmit these reports to the MAH and there must be an SDEA in place to control and guarantee that no safety data falls through any “gaps”. It is imperative that all the data gets through and there needs to be a system of acknowledgement of receipt and reconciliation of data sent and received.
  • Depending on the relationship, the SDEA may have to include assignation of responsibility for EU QPPV, PSUR writing, literature searching, the submission of reports to regulatory authorities, answering regulatory authority questions, handling product complaints, signal detection, hosting the safety database and ongoing benefit-risk evaluation.
  • If some or all pharmacovigilance activities are being outsourced, including Medical Information, Call Centres, Adverse Event Processing, the SDEA needs to be comprehensive, detailing which parties are responsible for which activities, even though the ultimate responsibility lies with the MAH. None of the above lists are exhaustive - the types of data and activities governed by SDEAs will differ from company to company and from product to product.
  • All the SDEAs must be part of the MAH’s quality management system and the writing, approval and documentation of each SDEA and each type of SDEA must follow company SOPs and be auditable. This is a regulatory requirement and SDEAs are inspected during pharmacovigilance inspections and audits.
  • Our teams construct robust, reliable agreements to ensure there is a mechanism whereby the correct data can reach the correct destination within a prescriptive and compliant timescale, ensuring that all activities occurring throughout the transit process are compliant with the regulations governing them.