Post graduate diploma in Global regulatory affairRaaj GPRAC
- Post Graduate Diploma
Frequent Asked Questions
· What are the objectives of this course?
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. To provide a sound knowledge and understanding of Global regulatory affairs. To create a thorough understanding of important regulatory concepts. Deliver innovative, breakthrough regulatory strategies for product development and registration. Be proactive and forward thinking; provide timely, comprehensive and robust global regulatory guidance. Understand the pharmaceutical environment and regulatory actions on precedents and utilize such regulatory intelligence. Forge new standards to deliver more predictable outcomes. Increase focus on building and strengthening relationship with regulatory authorities to provide timely expert input into product development, manufacturing and registration.
· Who is it intended for?
All those who have completed their Graduation or Post Graduation/ Pharma / PhD are eligible to enroll for the course. This course would be beneficial to people who have experience in RA and want to proactively take part in devising RA strategies. Professionals from pharmaceutical companies working in various departments.
What you'll learn on the course
Teachers and trainers (1)
Overview of Drug Development Process
Formulation or Product development
GMP, GLP and GCP
Regulatory System in US (FDA)
Medical Device Submissions
Topic 7: Biologics Submissions
Drug Substance Registration
Life Cycle of Drug Product
Regulatory System in Canada (Health Canada)
Regulatory System in Europe (EMA)
Topic 12: Drug Registration with Rest of the World (ROW
Dossier Preparation-Different Formats used globally
Dossier preparation in pCTD and eCTD format
Dossier preparation in ACTD format
ICH Quality Guidance’s and its importance21CFR Part 11 guidance and its importance