The process of creating scientific documentation by a qualified writer is known as medical writing. Typically, the researcher who conducted the research was not a scientist or physician who wrote the medical article. A medical writer develops documents that efficiently and precisely describe research findings, product usage, and other medical information in collaboration with physicians, scientists, and other subject matter experts. The medical writer also makes sure that the documents they produce adhere to regulatory, journal, and other standards for structure, content, and formatting.
Regulatory Affairs plays a significant role in the overall success of drug development, both early in the pre-marketing process and at all times after the product has been released. The pharmaceutical sector deals with an increasing number of intriguing drug candidates, all of which call for the department of regulatory affairs' involvement. In an increasingly global environment, regulatory affairs professionals can play a critical role in directing drug development strategy.
This course's main goal is to give students an interdisciplinary understanding of law and pharmacy as it relates to the field of pharmaceutical regulation at the national and international levels. The course equips students with the necessary skills to pursue careers in the pharmaceutical industry, drug licencing and control agencies, and export-import firms that deal with pharmaceuticals.
A candidate seeking admission to the above programme must have passed bachelor degree in pharmacy or medical sciences. A candidate having bachelor Degree in any discipline with two years of experiences in Pharma industry will also be eligible.
- Introduction to Clinical Research
- Preparations & Planning for Clinical Trials
- Introduction to Regulatory Affairs
- Global Regulatory Environment
- Pharma Regulations Practices & Procedures
- Import and Export of Drugs in Global Pharmaceutical Industry
- Common Technical Document
- Good Manufacturing Practice
- Quality Assurance and Regulation
- Regulatory Aspects in Pharmacovigilance
- Regulations Governing Clinical Trials & New Drugs
- Global Drug Policy
- Essential Documentation in Clinical Research & Regulatory Submissions
- Clinical Trials Project Planning & Management
- Study Start Up Process
- Clinical Monitoring Essentials
- Compliance, Auditing & Quality Control in Clinical Research Program