Types Of Safety Data Exchange Agreement

In addition, there must be a follow-up of companies that violate the agreements by sending late reports or by sending no reports at all. How to identify a company that is a remote site and does not send serious adverse events is another difficult topic and involves cooperation with the company`s quality and audit groups. The main objective of the pharmacovigilance agreement is to define a mechanism to ensure the flow of end-customer safety information to the competent authorities via the PDO. In order to ensure the achievement of this objective, it is the obligation of the POC to evaluate commercial contracts and to determine whether the clauses set out therein with regard to counterparties` commitments to photovoltaics are sufficient to carry out the activities. On the basis of that assessment, it is appropriate, where appropriate, to establish an autonomous agreement for which the period of validity of the last consignment marketed of the products concerned should be later than the date of validity. Nor should that period of effect take place at the end of the trade agreement concerned. Effective management of pharmacovigilance aspects of trade agreements is essential for all parties involved. Ensuring the inclusion of important pharmacovigilance concepts in agreements and monitoring compliance with them can be a challenge, but it is essential to comply with current regulatory requirements for medicines. At a minimum, the AEDS should allow for a rapid exchange of all serious adverse events (SDEs) to determine if expedited reporting is required. This applies both to clinical trials and post-marketing situations as well as to specific programmes such as patient support programmes. Some companies only want MedWatch or CIOMS I forms for each case; Others also want the source documents. The types of safety data obtained can be very different, they can be reports of adverse events, but there can also be other safety data: reports of abuse, abuse, overdose, medication errors, use during pregnancy, lack of effectiveness – and others.

The FMA must have a system in place to receive these reports, Part 3 must have processes in place to transmit these reports to the FMA, and an AEDS must be in place to monitor and ensure that no safety data is due to « deficiencies ». .