The regulatory affairs are often confused with quality assurance concepts as both have slightly similar work description. Still, there are major differences in the roles played by each domain within clinical research. The clinical research courses allow individuals to understand the in-detailed core of each clinical concept to effectively utilize them in specific fields. The individuals also get chance to explore other aspects of clinical research such as regulatory affairs, pharmacovigilance, clinical ethics and more.
How to differentiate quality assurance from regulatory affairs?
Clinical research courses also emphasize upon the thin line between regulatory affairs and quality assurance to endure patient and drug safety but the key difference is observed during its implementation in real life. Let's start by defining each term:
Regulatory affairs: Regulatory affairs is a governmental body within industries such as pharmaceuticals, medical devices, cosmetics, agrochemicals, and food-security industries which aims to oversee the major clinical research tasks such as manufacturing, testing, marketing and distribution of the newly developed or improved versions of drugs. Mostly, it is of high relevance in the public health industry which overlooks the task completion with protocol compliance. To understand the regulatory affairs a participant must understand the concept of the clinical research courses like what it is exactly consist of.
Quality assurance: Quality assurance is a profession that ensures the product meets every quality standard for the purpose of product distribution in the market. The quality assurance branch complies with internal as well as external rules and regulations set by local, state or national level governing bodies.
Thus, the clinical professionals are required to enroll in a regulatory affairs courses to learn more about the roles of such regulations in the clinical industry. This is of great help to majority industries as quality assurance and regulatory affairs work hand-in-hand. Where as in clinical research courses a participant learn about the diagnostic methods and the treatments of the diseases.
Relevance in terms of clinical research
The patient inclusive aspect is put at pedestal during conducting clinical trials. In clinical research courses, individuals gain the opportunity to explore in-depth about every clinical task such as patient data collection, pharmacovigilance aspects which cover patient security as well as drug efficiency, and many other elements. Thus, it is essential to get enrolled in clinical research courses to expand the scope of technical skills and knowledge in the field of clinical research. When a participant get enrolled in the clinical research courses they gain the overall knowledge about the diseases their treatments and the diagnosis.