Post graduate diploma in Global regulatory affair

Raaj GPRAC
In Thane

Rs 45,000
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Important information

  • Post Graduate Diploma
  • Thane
  • Duration:
    9 Months
  • When:
    Flexible
  • Credits:
Description

Introduction to RA profession

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 importance
21CFR Part 11 guidance and its importance

Important information
Venues

Where and when

Starts Location Timetable
Flexible
Thane
400609, Maharashtra, India
See map

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

GMP
GCP
ICH
USFDA
MHRA
TGA

Teachers and trainers (1)

Rajashri Ojha
Rajashri Ojha
Teacher

Course programme

Introduction to RA profession
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

Additional information

For further enquiries or Prospectus, write to or call us on: localhost, info@rajgprac.com , raajgprac@gmail.com, rajashrio@gmail.comwww.raajpharmaelearning.com,@mtnl.net.in Phone no: 9819488208 / 9821144706 / 022 65619030 /022 25445541

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