M.Pharma Drug Regulatory Affairs

Maharshi Dayanand University
In Rohtak

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Important information

  • Master
  • Rohtak
Description

Important information
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Where and when

Starts Location
On request
Rohtak
Maharshi Dayanand University,Rohtak - 124001,Haryana , 124001, Haryana, India
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Course programme

DRUG REGULATORY AFFAIRS –

Unit I
A detailed study of Federal Food, Drugs and Cosmetics Act of USA, restricted to
human drugs, cosmetics and biotechnological products, with special emphasis on:
a. History of drug regulation in USA.
b. Organization and functions of FDA, including historical developments.
c. General definitions.
d. Adulterated & misbranded drugs/cosmetics/biotechnological products.
e. OTC drugs, Orphan drugs, Orange Book and Fast Track Products.
f. General penalties as applicable to drugs, cosmetics and biotechnological
products.
Unit II
A detailed study of Federal Food, Drugs and Cosmetics Act of USA, restricted to
human drugs, cosmetics and biotechnological products, with special emphasis on:
a. General drug approval process.
b. Investigational New Drug application.
c. New Drug Application and BLA.
d. ANDA.
e. SNDA, SUPAC and BACPAC.
f. Post marketing surveillance.

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