Regulatory Harmonization and Streamlining of Clinical Trial Applications globally should lead to faster clinical development and earlier access to life-saving vaccines.

Regulatory Harmonization and Streamlining of Clinical Trial Applications globally should lead to faster clinical development and earlier access to life-saving vaccines. Vaccine. 2021 Jan 06;: Authors: Scheppler L, De Clercq N, McGoldrick M, Dias J Abstract Vaccines continue to play a central role in our ability to prevent disease, save lives, and improve health. The scientific community, including our own researchers, are driven by a shared purpose to improve vaccine technologies and bring the benefits of immunization to everyone, regardless of where they live - as soon as possible, especially when the medical need is considerable. Vaccine developers and manufacturers (sometimes referred to as "study sponsors" or "applicants") are exploring technological advancements to translate breakthrough discoveries into novel vaccines which have the potential to provide protection from life-threatening and debilitating infectious diseases. Developing new vaccines is a lengthy process regulated by guidance provided by independent organizations, National Regulatory Authorities (NRAs) and the World Health Organization. As most infectious diseases can span a considerable area of the world, clinical trials are often conducted across different countries and regions. Regulatory requirements for clinical trials (both Chemistry Manufacturing & Controls - CMC, nonclinical and clinical) vary significantly between the different countries and regions ad...
Source: Vaccine - Category: Allergy & Immunology Authors: Tags: Vaccine Source Type: research