COREX team members were invited to a meeting of the Association of Clinical Trials Organizations (ACTO) Logistics Committee that was held in August. During a lively debate, a vital for the pharmaceutical industry initiation of new medicinal products’ labeling protocols and procedures in the Russian Federation was addressed.
In the course of the meeting several questions about the turnover of drugs and their withdrawal from circulation were discussed; another important matter that sparked an exchange of opinions had to do with the amount of responsibility that would fall on organizations that manage these activities. COREX’ quality director, Vitaly Shakhnazarov, spoke about our company’s approach to handling of drug labeling. It is worth mentioning that the proposed solutions have been designed to address the changes in labeling in a cost-conscious manner.
The panel had concluded that at present time some of the issues with the upcoming changes in drug labeling reform have more questions than answers and that an ongoing dialogue with the regulatory bodies to address perceived limitations is paramount.