M.Pharm Pharmaceutical Regulatory Affairs

Jss College Of Pharmacy, Mysore
In Mysore

Rs 4,00,000
VAT not incl.
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Important information

  • Master
  • Mysore
  • Duration:
    24 Months
Description


Suitable for: B.Pharm graduates.

Important information
Venues

Where and when

Starts Location
On request
Mysore
570015, Karnataka, India
See map

Course programme

The first year M.Pharm has 4 theory papers with practical components. After completing the first year, the candidate shall carry out project work for 6 months in Regulatory affairs Dept. of Pharmaceutical Industries and in turn carry out minor project for 3 months in the institution.

The papers for the first year are as follows.

PAPER - I

Pharmaceutical Quality Management

Scope: This course is designed to impart fundamental knowledge on pharmaceutical quality management. It prepares the students for most basics of good manufacturing practices, documentation, auditing, validation and quality management in a pharmaceutical industry.

Objectives: Upon the completion of the course the student shall be able to:

1. know the current GMP requirements for a pharmaceutical industry;

2. prepare various documents in relation to manufacturing of dosage forms;

3. understand various audits and standard certification by agencies; and

4. appreciate the importance of pharmaceutical quality management.

PAPER - II

Pharmaceutical Regulations in India

Scope: This course is designed to impart fundamental knowledge on pharmaceutical regulations in India. It prepares the students for basic regulatory requirements in India such as approval of drug products for importing, exporting, manufacturing, sale and marketing authorisation, conducting clinical trials, patent procedure.

Objectives: Upon the completion of the course the student shall be able to:

1. Know different laws and acts that regulate pharmaceutical industry in India.;

2. Understand the approval process and regulatory requirements for neutraceuticals

3. Prepare the drug regulatory approval process and their registration in Indian market; and

4. Filing and getting approval for a patent application in India.

PAPER – III

International Pharmaceutical Regulations

Scope: This course is designed to impart the fundamental knowledge on the regulatory requirements for approval of new drugs, drug products, medical devices, biological, biosimilar, herbal products and nutraceuticals in regulated countries like US, EU, Japan, Australia, UK and Canada. It prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products in regulated countries.

Objectives: Upon completion of the course, the student shall be able to know

  • process of drug discovery and development and generic product development
  • process and procedures for conducting clinical trials and its importance
  • regulatory approval process and registration procedures for drug products in US, EU, Japan, Australia, UK and Canada
  • regulatory approval process for Medical Devices, In vitro Diagnostics, biologics, biosimilars, herbal products and nutraceuticals in US and EU
  • PAPER – IV
  • Pharmaceutical Regulations in ROW Countries*

    Scope: This course is designed to impart fundamental knowledge on Regulatory Requirements for generic drug registration, new drugs and post approval requirements in emerging market (rest of world countries) like BRICS, CIS,GCC, LATAM, ASEAN. It prepares the students to learn in detail on Regulatory Requirements for generic drug registration, new drugs and post approval requirements in rest of world countries.

    Objectives: Upon the completion of the course the student shall be able to:

    1. know the regulatory Requirements for generic drug registration in emerging market;

    2. carryout the market authorization requirements for generics and post approval requirements in emerging market;

    3 understand the registration requirements of emerging market by comparision; and

    4. prepare dossiers for the registration of the products in emerging market.


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