Regulatory Affairs in brief
Regulatory affairs is a relatively new professional field. It emerged in the 1980s, when governments worldwide became compelled to better protect the public. Such protection includes ensuring that all medicines reaching society are optimally safe and effective. Regulatory professionals were developed to integrate sound regulatory practices into projects from start to finish, keeping them on the right legal track.
In the realm of clinical research, they assist their peers with clinical trials applications, from early days, ensuring that all the documents and processes accompanying a project are in place and are of the quality required. Regulatory affairs professionals assist in reviewing study plans (protocol) and preparing submissions to national authorities, amending as needed, placing the trial in a registry, and following it through with the final study reports. All documents must be reviewed, complete, scientifically accurate, in regulatory compliance, and presented so as to facilitate the review and approval process of the ethics committees and – if needed – of the competent authorities.
Would you like to know how the experts in the Regulatory Affairs Platform are channeling their efforts? For more information, consult the fact sheet below.