Post Graduate Diploma in Regulatory Affairs
Post Graduate Diploma
Online
Description
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Type
Post Graduate Diploma
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Methodology
Online
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Location
Bhopal
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Duration
6 Months
To increase the understanding of the regulatory process in the field of Pharmaceuticals, clinical research, pharmacovigilance & patents.
Facilities
Location
Start date
Start date
About this course
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.
Reviews
Course programme
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
Post Graduate Diploma in Regulatory Affairs