REGULATORY AFFAIRS (CUTM1586)

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Course Name :

REGULATORY AFFAIRS

(CUTM1586)

 

Code(Credit) : CUTM1586(4-0-0)

Course Objectives

  • The objective of the course is to understand
    • The Concepts of innovator and generic drugs, drug development process
    • The Regulatory guidance’s and guidelines for filing and approval process
    • Preparation of Dossiers and their submission to regulatory agencies in different countries
    • Post approval regulatory requirements for actives and drug products
    • Submission of global documents in CTD/ eCTD formats
    • Clinical trials requirements for approvals for conducting clinical trials
    • Pharmacovigilence and process of monitoring in clinical trials.

Learning Outcomes

Course designed to impart advanced knowledge and skills required to learn the concept of generic drug and their development, various regulatory filings like IND, NDA and ANDA in different countries, different phases of clinical trials and submitting regulatory documents.

Course Syllabus

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Session Plan

Session 1

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Session 2

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Recent Comments

Course Name : Title Here

Code(Credit) : ABC01(1-1-0)

Course Objectives

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Learning Outcomes

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Course Syllabus

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Session Plan

Session 1

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Session 2

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Case Studies

Case Studies

Recent Comments

Course Name : Title Here

Code(Credit) : ABC01(1-1-0)

Course Objectives

  • I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

Learning Outcomes

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Course Syllabus

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Session Plan

Session 1

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Session 2

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Case Studies

Case Studies

Recent Comments

Our Main Teachers

Rasmita Jena

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