Post Graduate Diploma in Regulatory Affairs


Rs 20,000
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Important information

  • Post Graduate Diploma
  • Online
  • Bhopal
  • Duration:
    6 Months

To increase the understanding of the regulatory process in the field of Pharmaceuticals, clinical research, pharmacovigilance & patents.

Important information

Where and when

Starts Location
On request
Medical Director Cliniminds Unit of Tenet Health Edutech Pvt. Ltd. C-55, 1st Floor, Preet Vihar, Main Vikas Marg, 110092, Delhi, India
See map

Frequent Asked Questions

· Requirements

MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and hospitals.

Course programme

This course has especially been designed for the students who would like to develop their
career in the field of regulatory. Upon completion of the program students would understand the
concept of Regulatory Affairs in the field of pharmaceuticals, clinical research, patents &
pharmacoviglance; how the product is marketed on other countries, what are the legal
requirements of regulatory bodies, procedure for the submission of documents etc. After
completion of the program, students would become reasonably well versed in regulations
governing pharmaceutical and clinical research domain. Program would include :
 Introduction to Clinical Research
 Principles of Good Clinical Practices
 Ethical Considerations in Clinical Research
 Indian Regulatory Environment
 Introduction to Regulatory Affairs
 Pharma Regulations Practices & Procedures
 Import and Export of Drugs in India
 Good Manufacturing Practice
 Quality Assurance and Regulation
 General Overview of Pharmacovigilance
 Regulatory Aspects in Pharmacovigilance
 Regulations Governing Clinical Trials & New Drugs
 Drug Policy in India
 Future of Regulatory Compliance
 Orphan Drugs
 Regulation In Pharmaceutical Devices
 Trips and Pharma Industry
 Biomedical Intellectual Property Management
 Patent Application Processing Flowchart

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