GlobalInstituteofRegulatoryAffairs

Department of Regulatory Affairs is a crucial part of any pharmaceutical, biopharmaceutical, medical device, nutraceuticals, veterinary, and cosmetic industry. The department is focused on maintaining the quality standards and safety of medicinal products in different markets around the world. To make this possible, the regulatory professionals keep a close eye on all the products on various parameters such as development, manufacturing, testing, and distribution. This department also works closely with the government authorities to regulate the activities of the company. A career in regulatory affairs offers immense opportunities and growth for students keen to learn and acquire knowledge.   Skills Required for Regulatory Affairs The rules and regulations around the world are different for every region around the world. These rules are much more stringent for pharmaceutical and medicinal products owing to the safety of the public. Hence, regulatory professional has to be on their toes

  The pharmaceutical and healthcare sector has grown tremendously in the past few years. Which, pharmacovigilance is coming out as a viable option for students to build a stable career. The career growth and opportunities in Pharmacovigilance are immense. Pharmacovigilance aims to gather, understand, assess, and prevent adverse effects of a drug or medicinal product. This is done by various processes such as 1. Individual Case Safety Reports (ICSR). 2. Clinical Review of Safety Reports. 3. Cohort Event Monitoring. 4. Longitudinal Electronic Patient Reports. 5. Periodic Safety Update Reports (PSUR). 6. Spontaneous Recording. 7. Record Linkage. 8. Expedited Report. A candidate in pharmacovigilance performs the following functions: 1. Reporting adverse events received from customers or healthcare bodies. 2. Reducing the risk of serious side effects. 3. Creating and reviewing serious adverse effects reports. 4. Performing safety audits. Types of Companies Hiring in Pharmacovigilance Pharma