Post graduation diploma in Drug regulatory affair in API
Post Graduate Diploma
Distance
Description
-
Type
Post Graduate Diploma
-
Methodology
Distance learning
-
Duration
6 Months
-
Start date
Different dates available
-
Delivery of study materials
Yes
1) Introduction to RA profession
2) API Characterization and Polymerization Impurities
3) Regulatory System in US (USFDA)
4) Regulatory System in Europe (EMA)
5) DMF preparation in CTD format
Procedure of filling in European country (related to DMF)
Certificate of Suitability (CoS)
Important information
Documents
- 6m Advanced PGDRA-API_ RaajGPRAC.pdf
Facilities
Location
Start date
Start date
About 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.
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
Reviews
Subjects
- Drug Laws
- DMF
Teachers and trainers (1)
Rajashri Ojha
Teacher
Course programme
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)
Additional information
Post graduation diploma in Drug regulatory affair in API