M.Pharm (Drug Regulatory Affairs)

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PHARMACEUTICAL REGULATORY AFFAIRS

Regulatory Affairs (RA) is a relatively new calling which created from the craving of governments to ensure safe, effective and quality medicines in the field of pharmaceuticals, medical devices, cosmetics, biologicals, vaccines, herbals, veterinary medicines, clinical trials and pharmacovigilance. RA professionals play a crucial role in the pharmaceutical industry through the accelerated product development and regulatory submission. In the present situation, time taken for a drug to reach the market is dependent on RA professional and they act as a bridge between pharmaceutical industries and regulatory agencies.

VISION:

To make Sri Adichunchanagiri College of Pharmacy, a desired college to study Pharmaceutical Regulatory Affairs

MISSION:

To incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the students with the latest developments to serve the industries.

PROJECT OBJECTIVE:

  • To prepare professionals for regulatory affairs positions in the pharmaceutical sector.
  • To facilitate the students knowledge with proper foundation in advancing them in the regulatory profession.
  • Provide fundamental basics as per industrial requirement in the field of regulatory affairs.
  • Keeping track of the ever-changing legislation in all the regions.
  • Update students with thorough and up-to-date knowledge of global laws and regulations, applicable in the various stages of drug development.
  • Theoretical and practical knowledge in preparing, compelling and submitting required documents as per industry and regulatory authority needs for the registration of healthcare products.

Faculty

SL. NO

FACULTY NAME

QUALIFICATION

DESIGNATION

1.

Dr. Prakash S Goudanvar

M.Pharm., Ph.D

Professor

2.

Dr. Vedamurthy Joshi

M.Pharm., Ph.D

Associate Professor

3.

Mr. Venugopal N

M.Pharm.

Assistant Professor

Adjunct faculty from Pharma-Industries:

Dr. Premnath Shenoy, 35+years in AstraZeneca, pharmaceutical Industrial Consultant.

Dr. Umanandan Mishra 35+years in AstraZeneca.

Dr. Parameshwaran 20+ Yrs in PharmaIndustry.