engleski

Emerging markets and international regulations in the transport of clinical research shipments

The variety of international regulations concerning the transportation of perishable and temperature sensitive products called for a global harmonization in order to facilitate the international character in transportation of these products. In order to safeguard products themselves and offer the solutions and know-how, the number of regulatory bodies driven by the vast experience of specialists gathered in several stakeholders all over the world, offered their expertise providing the related industries with guidelines on the good production, storage and distribution practices for temperature sensitive products. Clear communication of these guidelines and their interpretation throughout the different stakeholders in the production and distribution process is important in order to secure these products in following the international regulations as well as recommendations later considered in the evaluation of the processes. Considering the international character in production of IMPs (Investigational Medicine Products), the analysis of the emerging markets enables those responsible for the organization and conduction in good distribution practice to foresee the related specifics thus contributing to the overall patient safety. One of the most demanding categories of perishables and temperature sensitives, recently brought into focus, are the pharmaceutical products. The growth projected for the pharmaceutical industry derived from the extended need for more answers and solutions expected for the future, brought the industry into the focus thus aiming at optimizing the regulatory issues at a global level. Securing the same conditions applied in all areas of the production, storage and distribution of pharmaceuticals worldwide became the target for a number of regulatory bodies and related stakeholders.

Perishable and temperature sensitive products; emerging markets; biological substances; interest groups; standards and recomendations; serivce agreements

nije evidentirano