Clinical trial designs for radiopharmaceuticals will be analyzed in Cuba

Havana, Oct 29 (RHC) The designs of clinical trials and preclinical studies of radiopharmaceuticals will be discussed at the Regional Workshop on Health Regulatory Requirements for these products, which will be held at the Palco Hotel in Havana until October 31.

The event will also provide a platform for representatives from Argentina, Bolivia, Costa Rica, Colombia, Brazil, Cuba, and Mexico to present their regulatory frameworks.

The workshop will feature presentations from the Dominican Republic, Panama, Peru, and Uruguay, who will discuss the essential points and challenges in regulating radiopharmaceuticals, which are defined by the International Atomic Energy Agency (IAEA) as medicines containing radioactive forms of chemical elements known as radioisotopes.

These radioisotopes can be used for imaging and treating various health conditions, including cancer and hyperthyroidism.

During the opening presentation, Mayka Guerrero from the Specialized Diagnostic and Treatment Center of Cuba’s Center for Medical Surgical Research, noted that the workshop aims to share experiences in compliance with health regulations during the approval process for radiopharmaceuticals.

According to Manuel Fernández, Director of Science and International Cooperation from the Agency for Nuclear Energy and Advanced Technology of the Ministry of Science, Technology, and Environment of Cuba, this event serves as a framework for producers and regulatory bodies to reach a consensus on best practices in producing these medicines.

Enrique Estrada Lobato from the IAEA's Human Health Division acknowledged Cuba's significant role in developing nuclear technology with medical applications. He stated that for many years, the country has trained professionals from around the region, and Cuban experts have also helped train people in Latin America. (Source: PL)