ROLE OF A REGULATORY AFFAIRS PROFESSIONAL
The primary responsibilities of pharmaceutical regulatory affairs professionals in clinical trials in order to get drug approval are mentioned below:-
Literature Searching: Pharmaceutical Regulatory Affairs professional are responsible for searching literature regarding clinical trials as it enables to acquire an understanding of the clinical trial study and also keep us aware of relevant research that has already been conducted.
Assembling Regulatory Submission: Pharmaceutical Regulatory Affair professional is responsible for gathering information, preparing clinical trial dossiers and making regulatory submissions. Submissions include annual reports, addition of new investigators to clinical protocols, certificate of analysis, amendments proving for changes in clinical trials and routine and supplemental filings.
Documentation: The most important part of pharmaceutical regulatory affair is that all the collected information should be documented. The reason is that conducting a clinical trial is a very lengthy process and requires a lot of time. So there might be a change of person working with the project. To tackle such situations documentation is essential.
Pharmaceutical Regulatory service professional is responsible for keep an update on changes in regulatory guidelines. Being up to date in regulations is essential as it can effect the clinical trial process, regulation strategy and decisions on what kind of trials are needed etc. All changes in regulations must be documented and finally interpreted and communicated with the appropriate people in the company.
Reporting of Serious Adverse Events: If any serious adverse event occurs during clinical trial, it is notified by sponsor to Pharmaceutical Regulatory service professional and they are responsible for reporting these adverse event reports in written form to the regulatory authorities. Thus they are the one who reports on the status of clinical trial.
Apart from these, pharmaceutical regulatory affair professional facilitate in arranging the meeting of sponsor with drug regulatory authorities and also assist with the inspection and audits. They should also focus on the implementation of clinical studies with emphasis on study drug management and reviewing data from clinical trials.
TO KNOW ABOUT OUR PHARMACEUTICAL REGULATORY SERVICES CLICK HERE
