Analyzing the quality of a product has gained spotlight just a few years back. As important as developing the product, it has become equally important for the product to undergo a testing process in order to attain 100% outputs. As per the estimated records, technology is focusing more on software quality assurance rather than the manual testing process. The concept of Quality assurance went into the mainstream to overcome the tedious manual testing process and making the process easy, accurate and simplified.
This Course enables the learner to know and understand the basics of Pharmaceutical Industry, Quality Assurance System followed in Industry, basics of Total Quality Management System
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. It serves as the interface between the regulatory authority and the project team, and is the channel of communication with the regulatory authority as the project proceeds, aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product.
Pharmacovigilance is a scientific discipline which mainly pertains with identifying, validating, quantifying, evaluating and minimizing the adverse effects of therapeutic drugs, devices or biologics in order to increase their safety. The clinical research regulatory agencies worldwide including US FDA, Indian DCGI and EMEA etc., are strengthening the safety laws for adoption of a systematic Pharmacovigilance framework. The adverse event data generated by clinical trials worldwide is enormous and has led to the outsourcing of the Pharmacovigilance and Pharmacoepidemiology services of the Pharma-Biotech Research and Development.