AUTOMATION (RPA AND AI) IN REGULATORY MEDICAL WRITING – AN OVERVIEW
Writing a regulatory document is a difficult and time-consuming task. It is because of the presence of a large amount of data and strictly following the regulatory guidelines. Robotic process automation and artificial intelligence help in easing the load on regulatory medical writers.
REGULATORY MEDICAL WRITING
Regulatory medical writers help the pharmaceutical, biotechnology, and medical device organization to apply for the approval of medical drugs and devices. The regulatory writers are experts in understanding the procedures, formats, and guidelines of respective drug and medical device regulatory authorities. Further, the regulatory writer also helps filing several documents, such as post-marketing surveillance or pharmacovigilance obligations after the approval.
The regulatory medical writers are employed by the pharmaceutical companies and several clinical research organizations that help them to develop complex regulatory documents. The regulatory documents may include the protocols, synopsis, rationale and justification, and other manufacturing-related details.
CHALLENGES IN REGULATORY MEDICAL WRITING
Regulatory medical writing has several challenges. Some of the challenges are inherent to the regulatory domain, while the other challenges are commonly present in almost all fields of medical writing. Some of the challenges of regulatory medical writing are:
- More complex and time-consuming: As compared to other medical writing domains, like medical communication and medical branding, regulatory medical writing is more complex and required an in-depth understanding of the formulation under consideration. More research is required to develop the regulatory documents.
- Time-restriction: Although all medical documents have time limitations, the consequences of lapsing the final date in filing the regulatory document are serious. It is critical to respect the timelines in case of filing regulatory documents.
- Structured: The challenges in writing the regulatory documents are that they are more structured, and it is necessary all the time to maintain consistency
- Accuracy and consistency: The content should be accurate, consistent, and without any ambiguity. Failing this may result in document rejection.
ROBOTIC PROCESS AUTOMATION IN REGULATORY WRITING
There are complexities in the drug regulatory environment. Increased document strictness, frequently changing the guidelines, the addition of new requirements, and the incorporation of additional data requirements result in the demands for more advanced technological solutions.
Robotic process automation is one such solution that may help in managing the drug regulatory complexity. It offers several advantages to the people working in drug regulatory departments. There are several types of robotic process automation. Some are simple while the others are more complex. The complexity depends upon the type of work done through the automation.
Some of the simple tasks that are assisted and made easy through robotic automation include data extraction from the excel sheet, automatic data entry, data upload on the server, archiving and importing useful documents, and checking the document consistency and quality. It saves significant time for the regulatory writers. It also helps in speeding up the regulatory approval process.
Regulatory Process Automation also helps in checking the documents that are to be submitted for regulatory approval. The automated process may help in checking the setting and the bookmarks. It also helps in arranging a lot of data that is coming from the clinical research organizations in case of approval of a drug that requires clinical trials.
ARTIFICIAL INTELLIGENCE IN REGULATORY WRITING
Artificial intelligence significantly changed the regulatory writing domain. The number of regulatory filings is increasing and simultaneous clinical trials of several drugs are under process. It will result in the generation of a lot of complex data. Artificial intelligence developed specifically for regulatory affairs helps in providing the updated regulatory requirements from several regulatory authorities, such as USFDA, UK-MHRA, TGA, and Health Canada. Artificial intelligence also helps in managing the drug development process and ensuring that everything is streamlined as per the requirements of the regulatory authority. Data mining and data analysis are the other functions performed by artificial intelligence in regulatory affairs. Artificial intelligence also helps in better communication and coordination within the regulatory team.