Diploma in Regulatory Affairs (OEP)
Diploma in Regulatory affairs online course will provideanfundamental knowledge on various practices (viz., GMP, Quality related aspects) documentation requirements, laws and regulations for the manufacture of pharmaceuticals, the regulatory requirements for life cycle management of pharmaceuticals.
- The objectives of this course are to provide thorough knowledge To create a thorough understanding of important regulatory concepts
- To create experts in the field of regulatory affairs documentation and re- search.
- To create an entry platform in the field of regulatory affairs for fresh grad- uates.
- To help students build their career in regulatory affairs and become regu- latory affairs professionals.
- To provide students with a global knowledge of Regulatory Affairs.
- Finally Students can able to write Regulatory Document ,Create Regulatory Strategy , Get Marketing Authorization from different countries become an regulatory affairs professional.
Goals and Objectives:
At completion of the course, it is expected that students will be able tounderstand
- Key regulatory and compliance related to good manufacturing practices
- Know various documents pertaining to drugs in pharmaceutical industry
- Know different acts and regulations that regulate drugs and cosmetics in India
- Prepare for the readiness and conducts of audits and inspections
Any graduates pursuing in the field of Pharmaceutical Sciences, Medical Sciences, Veterinary Sciences, Biotechnology, Microbiology and Life Sciences from any recognized institution.
INR 40,000/- per Year for Indian Nationals
USD 600 per Year ( Equivalent in INR would be charged)
EXAMINATION FEES-1500 INR PER SUBJECT
Forms
- Syllabus
The Tamilnadu Dr MGR Medical University, Chennai
JSS College of Pharmacy, Ooty
The Tamilnadu Dr MGR Medical University, Chennai
Sri Ramakrishna College of Pharmacy
Jagadguru Sri Shivarathreeshwara University
JSS College of Pharmacy, Ooty
Department / Subject Taught
Pharmaceutics
Feb 10, 2007
3 Years 8 Months
Jul 06, 2010
3 Years 5 Months
Till Date
13 Years 10 Months
To become regulatory affair professional in pharmaceuticals and also to establish regulatory centre for dossier compilation consultant
Dr. G.N.K.Ganesh is an assistant professor and Course Coordinator department of pharmaceutical regulatory afffairs. His research focuses on self multiparticulate drug delivery system nano drug delivery system for the past one decade including nanoemulgel for topical application. To his credit he has 01 patents filed under Intellectual property of India for minitablets punch fabrication. Published research articles in reputed journals viz., Journal of Pharmaceutical Investigation, Journal of Bioequivalence and Bioavailability, Asian Journal Pharmaceutics to name some. He is interested in developing targeted drug delivery system which helps in the recrudescence cancer. He is currently involved in peptide based drug delivery system. Currently he is involved in regulatory science
Pharmaceutical Regulatory Affairs 'Data integrity, Life cycle management, impurity profiling'
Targeted drug delivery system
Tumor homing peptides