Post graduation diploma in Drug regulatory affair in APIRaaj GPRAC
- Post Graduate Diploma
- Distance learning
- Delivery of study materials
Frequent Asked Questions
· What are the objectives of this course?
1) To provide an overview on the general legal requirements to bring a pharmaceutical product to market –whether it is the creation of a new product, or import/export of a product to a new market – and maintaining it afterwards. 2) To decipher a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products. 3) To create experts in the field of RA documentation and research. 4)To help students build their career in RA and become RA professionals. 5) To provide students with a global knowledge of Regulatory Affairs. 6) To create a thorough understanding of important regulatory concepts. 7)To create experts in the field of RA documentation and research. 8) To encourage continuous learning and development in RA field. 9) To clear the basic fundamentals of RA. 10)To update knowledge of existing RA professionals.
· Who is it intended for?
1)All those who have completed their Graduation or Post Graduation/Pharma / PhD are eligible to enroll for the course. 2)This course would be beneficial to people who have experience in RA and want to proactively take part in devising RA strategies. 3)Regulatory Affairs Professionals. 4)Professionals from pharmaceutical companies working in various departments. 5)Research Chemist, Quality Control Chemist, CRO’s involved in Documentation 6)QC/QA Staff 7)Documentation Department
What you'll learn on the course
Teachers and trainers (1)
Role and its importance, overview of worldwide Regulatory agencies
2) API Characterization and Polymerization Impurities
Process impurities& Validation
3) Regulatory System in US (USFDA)4) Regulatory System in Europe (EMA)5) DMF preparation in CTD formatProcedure of filling in European country (related to DMF)Certificate of Suitability (CoS)