If a separate contract laboratory is involved, all relevant roles and responsibilities should be defined. The quality agreement should explicitly state what data is transmitted and how it is disseminated. The sponsor should implement a system to manage quality at all stages of the testing process. The proponent and examiner should sign the protocol or an alternative document to validate the agreement. For companies in the pre-authorization phase, Mr. Minsk advises on clinical trials, imports and exports, regulatory strategies, including 505 (b) (2) new pharmaceutical applications, orphan drugs, combined products, market exclusivity, premarket notifications, pre-authorization applications, communication with the FDA and pre-authorization discussions. It also designs and reviews agreements on clinical trials, quality and contract manufacturing. For commercial companies, he advises on lifecycle management, post-market monitoring, citizen petitions, FDA enforcement and inspections, fraud and abuse compliance, promotion and advertising, product liability and interactions with the FDA. He also works with life sciences and venture capital firms on regulatory due diligence issues related to acquisitions, divestitures, co-promotions and licenses.
Mr. Minsk organizes internal training on a wide range of FDA topics and fraud and abuse. An effective quality agreement identifies specific sites where the contracting entity performs manufacturing operations, including specific services to be provided on each site. 5.15.1 The proponent should ensure that the protocol or other written agreement stipulates that the auditor or institutions provide direct access to source data/documents for test monitoring, audits, IRB/CIS verification and administrative inspection. 5.1.2 The sponsor is responsible for guaranteeing to all parties concerned the direct access agreement (see item 1.21) to all websites, sources/documents and reports relating to monitoring and review by the promoter, as well as inspection by domestic and foreign regulators. The proponent should decide which risks are reduced and/or what risks should be accepted. The approach to reducing risk to an acceptable level should be proportionate to the magnitude of the risk. Risk mitigation measures can be included in the design and implementation of the protocol, monitoring plans, inter-party agreements on the definition of roles and responsibilities, systematic safeguards to ensure compliance with standard operating procedures, and training in processes and procedures. A reasonably detailed quality agreement can help avoid assumptions that lead to compliance errors. However, while a quality agreement defines the specific quality parameters of a project and the parties responsible for their implementation, the degree of detail varies depending on the stage of development of the project. A quality agreement should at least reflect the obligations and responsibilities of each party in the following basic elements, as set out in the guidelines: according to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in the manufacture of the contract, which defines and defines each party`s production activities for compliance with the CGMP.