M.Pharma Drug Regulatory Affairs

Master

In Rohtak

Price on request

Description

  • Type

    Master

  • Location

    Rohtak

Facilities

Location

Start date

Rohtak (Haryāna)
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Maharshi Dayanand University,Rohtak - 124001,Haryana , 124001

Start date

On request

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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.

M.Pharma Drug Regulatory Affairs

Price on request