The main actors in the implementation of SDEA are lawyers. All contracts are (or should in any case) be approved by the legal department. In small businesses, these issues are usually not a problem, as employees all know each other and work well together. In large companies, with lawyers sitting in offices on two or more continents, and with many lawyers dealing with different issues, it can be difficult to identify the person who is dealing with drug safety issues. To obtain the necessary approval and market their finished forms of loan, these MA holders may have different business relationships with other pharmaceutical companies, CROs or other service providers. These business relationships vary according to the requirements/consents/obligations/interests of both counterparties. These relationships are governed by framework service contracts/commercial agreements. The CSP should also be familiar with the rules applicable to the area concerned. The POC should be able to strike the right balance during the negotiations to cover both international and local rules.
Advising and approving the right stakeholders for the right tasks during the negotiations is the essential task that the POC must perform to ensure that the divisions concerned are in compliance with the agreed clauses. Knowledge of the scenarios alone may not fulfill the objective, as the same scenario may need to be derived differently with the zoning change. For example, the co-marketing situation at ANZ is different from that in Europe. Some local rules also make it mandatory for a MAH, some of the types of pharmacovigilance contracts (e.g.B. Type of manufacturer in Europe) on the basis of applicability. Therefore, the negotiations conducted by the POC are very important to give a final form to an agreement and they should be sufficiently cautious to conduct appropriate negotiations. To this end, companies must enter into written agreements with all parties, companies, individuals, investigators, CROs, patient support organizations, poison control centers (when used to collect ESAs), call centers, and other business partners who could obtain security data that a company needs. These include all companies mentioned in the label, such as distributors, manufacturers, partners, etc. These agreements are called Safety Data Exchange Agreements (SDEAs). They are requested and verified by the FDA and other health authorities during inspections. One of the most recent trends in the pharmaceutical world is the joint development and marketing of medicines.
This includes all kinds of agreements with other companies, both at home and abroad. We can now see several companies that would market the same drug in the United States and other companies that would market the drug abroad. Clinical trials may be conducted jointly or subcontracted to CROs or other pharmaceutical partners. All AEDSs must be part of the MAH quality management system and the letter, approval and documentation of each AEDS and any type of AEDS must comply with the company`s SOPs and be verifiable. This is a regulatory requirement and AEDS are inspected during pharmacovigilance inspections and audits. In these considerations, the agreement on the exchange of safety data plays a central role in all areas of the collection, evaluation and reporting of safety data in a given pharmacovigilance system. . .