Post graduation diploma in Drug Regulatory affair-Formulation.

Raaj GPRAC
Distance

Rs 22,000
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Important information

  • Post Graduate Diploma
  • Distance learning
  • Duration:
    6 Months
  • When:
    Flexible
  • Credits:
  • Delivery of study materials
Description

1)Introduction to RA profession
2)Regulatory System in US (USFDA)
3)Regulatory System in Europe (EMA)
4)Drug Registration with Rest of the World (ROW)
5)ICH Quality guidelines overview
6)GMP ANS GLP overview
7)Formulation development
8)Dossier preparation in CTD format
9)Electronic submission [21CFR part 11]

Important information Venues

Where and when

Starts Location Timetable
Flexible
Distance learning

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. To create a thorough understanding of important regulatory concepts. 2)To create experts in the field of RA documentation and research. 3)To encourage continuous learning and development in RA field. 4)To clear the basic fundamentals of RA. 5)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)Professionals from pharmaceutical companies working in various departments.

What you'll learn on the course

Drug Laws
Drug regulatory affair

Teachers and trainers (1)

Rajashri Ojha
Rajashri Ojha
Teacher

Course programme

  • Elaborate course material, self-assessment assignments and project work details would be provided by the Raaj GPRAC from time to time. Details get updated on the webpage as well.
  • All the students are obliged to timely submit completed assignments (during the pendency of the course) and appear for an online exam at the end of the course.
  • After successful completion, the student will be awarded “Post Graduate Diploma in Regulatory Affairs (Formulation)” by Raaj GPRAC

Additional information

Elaborate course material, self-assessment assignments and project work details would be provided by the Raaj GPRAC from time to time. Details get updated on the webpage as well. All the students are obliged to timely submit completed assignments (during the pendency of the course) and appear for an online exam at the end of the course. After successful completion, the student will be awarded “Post Graduate Diploma in Regulatory Affairs (Formulation)” by Raaj GPRAC

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