TypeOnline Course
(3 ratings)
Price$390 / Rs. 19500
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Course Deliverable



Admission Process

Course Objective – Pharmaceutical Regulatory Affairs courses are conceptualized with vision to create effective Regulatory Affairs Manager for Pharma Industry. This course gives practical knowledge of the functionalities of Regulatory Manager with practical exposure. This is ideally suits to those who wants Drug Regulatory Affairs Certification within a span of 1 month.

Career in Drug Regulatory Affairs

A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals.

The Pharma industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products. To maintain safety and efficacy in pharma & medical device products, regulatory agencies like US FDA,UK MHRA, EDQM, DCGI etc all over the world are imposing no of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease.

Our Registerants are in Orchid, Sanofi-Aventis, Astra-Zeneca, Hospira, Ranbaxy, Julphar, J&J-Ethicon, Pfizer, DRL, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, Shaigan Pharmaceuticals, Reliance Lifesciences, Quality Pharma Pvt Ltd, Cipla, Ipca, Sherya Lifesciences, Promed, Torrent Pharmaceuticals, Zydus Candila, Himalaya, Bangalore Pharmaceutical and Research laboratories, Teru Technomed, Indocoar Pharma, Fortis Hospitals, VRPL Healthcare, Medreich, Hospira, Indospectrum, Winatac Limited, Faveo Pharmaceuticals, Enzem, Leo, Accenture, Mylan, and many more companies across the pharma industry.

1. 6 different Printed Book / printable booklet provided to all course registrant

2. Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage. Refer Learning Schedules by scrolling down the page.

3. Flexible online final examination (Computer Based Test by secure mode)

4. Access to real life case studies

  • The Internationally Accredited course – Accredited by International Association of Distance Learning (IADL), UK
  •  Knowledge Process Enhancer is registered under Trademark Registry of India, under class 42.

Minimum qualification required is Graduation in any discipline or 2 years of work experience in pharmaceutical company.


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Course Content / Learning Schedules

Section 1Drug Regulation Fundamentals
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)
Lecture 4Abbreviated New Drug Application (ANDA)
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Review on Drug Discovery and Development
Lecture 7Generic Drug User Fees Act (GDUFA)
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Handling of orange book
Lecture 10Priority Accelerated Review
Lecture 11Practical Training on INDA, NDA, ANDA filing
Lecture 12505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivity 
Lecture 16Learning from New Drug Approvals
Lecture 17Orphan Drug & Orphan Drug Act
Section 2Clinical Trial
Lecture 18Clinical Trial Detailed Study (Topic - 1-11)
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent
Section 3Regulatory Strategies
Lecture 22Regulatory Strategies in different phases of Clinical Trial
Lecture 23Advance study on Para IV Filing
Lecture 24Evergreening - Patent Life Extension Strategies
Section 4DMF & SMF
Lecture 25DMF & SMF introduction
Lecture 26Site Master File
Lecture 27Practical Training on preparing DMF and SMF
Section 5USFDA warning Letter
Lecture 28CAPA
Lecture 29USFDA Warning Letter
Lecture 30Handling of warning letter
Section 6Drug Registration Dossier
Lecture 31CTD
Lecture 32Introduction to Electronic Common Technical Document (ECTD)
Lecture 33Advance Practical Training on Dossier Preparation focusing on drug registration in export countries