Certificate Course in Drug Regulatory Affairs (DRA)

"This course is specifically designed for newcomers and beginners in the pharmaceutical industry. If you are entirely new to the industry, we recommend starting with the 'Overview of the Pharmaceutical Industry' section. However, if you already have experience in the pharmaceutical sector, you can directly begin with Section II: 'Complete Pharmaceutical Regulatory Affairs Course'.

" Section-1 Topics: 1) What is pharmaceutical industry and different segments in Pharma industry. 2) Drug Development process in pharma industry. 3) Branded Drugs Vs Generic Drugs 4) Exploring Divisions within the pharmaceutical industry 5) Quality Assurance department 6) Quality control department 7) Role of R & D in Pharmaceutical industry 8) Role of Production department in pharmaceutical industry 9) Microbiology department 10) ETP and EHS departments 11) Regulatory affairs department Section-2 Topics: 1) Scope of Regulatory affairs in the pharmaceutical industry.

2) Introduction and Functions of USFDA 3) Drug approval process in United States 4) CTD & eCTD 5) Registration procedures for medicinal products-EU Region 6) Japanese Regulation (PMDA) 7) The Generic Drug User Fee Act (GDUFA) 8) Orange Book 9) Drug Master File (DMF) 10) ANDA & NDA Submission process 11) Stringent Regulatory Authorities 12) Conclusion video For pharmaceutical professionals, learning about drug regulatory affairs is particularly important for several reasons:1. Ensuring Drug Safety and EfficacyProtecting Patients: Understanding regulatory requirements ensures that drugs are safe and effective before they reach the market. This is critical for protecting patient health and maintaining public trust in pharmaceutical products.

2. Navigating Complex Approval ProcessesRegulatory Approvals: Pharmaceutical professionals must navigate the complex processes required to get a drug approved by regulatory bodies such as the FDA (U. S.