TypeOnline Course
Student Enrolled6
(10 ratings)
Price$650 / Rs. 32500
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Admission Process

Course Objectives:

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.

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 Lipoxen (UK), 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 Herbal Healthcare, 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. Printed Book / printable booklet provided to all course participants. There will be total 18 books will be provided. Refer syllabus copy to view the details. 

2. Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage. 

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

4. Access to 1000s of 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.

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.

27500.00 (From payment from India) / 550 USD for payment outside India


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Course Flow – 

Section 1Fundamental of Drug Discovery, Development (US Regulation)
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
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 10USFDA Expedited Programs (Detailed Understanding)
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
Lecture 15Patents Vs. exclusivity
Lecture 16Case Study New Drug Development & R&D Incentive Plans
Lecture 17Submission Requirements for Orphan Drug Designation
Section 2Clinical Trial / Research - Fundamental
Lecture 18Clinical Trial Detailed Study (Topic - 1-11)
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent
Section 3IPR Related Topics (Optional)
Lecture 22USPTO - Introduction
Lecture 23Patent - Fundamental Concepts
Lecture 24Patent Application Process - USPTO
Lecture 25Trademark Search and Registration in US
Lecture 26Steps Know How & Key Points - Patent Application
Lecture 27IPR - Patent Grant and Handling Process in India (Optional)
Lecture 28Patent Search in Indian Patent Office (Optional)
Lecture 29Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 30Trademark Search assignment (optional)
Lecture 31Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 32Regulatory Strategies in different phases of Clinical Trial
Lecture 33Advance study on Para IV Filing
Lecture 34Evergreening - Patent Life Extension Strategies
Lecture 35Drug Re purposing
Lecture 36Pay For Delay Strategy
Lecture 37Pediatric Exclusivity
Lecture 38Compulsory Licensing
Lecture 39Technology Licensing
Lecture 40In-Licensing Vs. Outlicensing
Lecture 41REMS - Strategic Planning
Section 5GMP
Lecture 42Definition of GMP
Lecture 43Certification Pharmaceutical Companies / Plants
Lecture 44Introduction to Good Manufacturing Practices
Lecture 45Premises & Plant Layout Designing
Lecture 46Sanitation and Hygiene
Lecture 47Equipment
Lecture 48Production Modules
Lecture 49GMP Documentation
Lecture 50Quality Control
Lecture 51Handling of Product Complaint
Lecture 52GMP Storage
Lecture 53ISO and ISO Audits
Lecture 54Pharmaceutical SOPs
Lecture 55SOP Automation
Section 6DMF & SMF
Lecture 56DMF & SMF
Lecture 57Site Master File
Lecture 58Practical Training on preparing DMF and SMF
Section 7Biosimilar
Lecture 59Introduction to Biosimilar
Lecture 60Biosimilar Approval process
Lecture 61Biological Licensing Application (BLA)
Lecture 62Vaccine development and approval Process
Section 8USFDA warning Letter & CAPA
Lecture 63CAPA - Introduction
Lecture 64USFDA Warning Letter
Lecture 65Handling of warning letter
Lecture 66Case Study: Warning Letter
Section 9Drug Registration in European Country (Optional)
Lecture 67Overview of EU Regulation
Lecture 68Orientation to European Countries and National Regulatory Bodies
Lecture 69Overview of EU Regulation
Lecture 70EMEA Procedures
Lecture 71Summary of Product Characteristics (SmPC)
Lecture 72Compassionate Use
Lecture 73MHRA - UK Regulation
Lecture 74EU Orphan Medicinal Products Regulation
Lecture 75The 'sunset clause' for marketing authorisations of pharmaceuticals
Section 10GCC Regulatory Affairs (Optional)
Lecture 76Regions in Pharma Business : Common Terminologies
Lecture 77GCC Pharma Market
Lecture 78GCC Export
Lecture 79GCC Registration Procedure
Lecture 80Drug Registration in Saudi Arabia
Lecture 81Documentation Required for the GCC countries
Lecture 82Drug Registration in Beherain, UAE, Kuwait, Qatar, Oman
Lecture 83Medical Device Regulation in GCC countries
Section 11Drug Registration Dossier
Lecture 84Introduction to Common Technical Document (CTD)
Lecture 85Asean Common Technical Document (ACTD)
Lecture 86ECTD
Lecture 87Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 88Modules on Stability Study
Lecture 89Stability Study Test
Lecture 90Module on Interchangeability
Lecture 91Stability Testing of API
Lecture 92Stability Testing of Finished Pharmaceutical Products
Lecture 93Review on Stability Testing
Lecture 94Black Box Warning
Section 12Portfolio Management and Related Topics
Lecture 95Advance understanding of the portfolio Management
Lecture 96Importance of market research in pharmaceutical industry
Lecture 97Co-promotion & Co-marketing strategy in pharma industry
Lecture 98Concept of Reverse co-promotion in pharma industry
Lecture 99Publication Management from Regulatory perspective
Lecture 100Juxtapid Case Study
Lecture 101New Indication Approval Process and Promotion
Lecture 102OTC Switch
Lecture 103Practical Case Study in Rx to OTC Switch
Section 13API Regulatory Affairs
Section 14Case Study Access
Lecture 10548 different topics of the Regulatory Affairs, Case Studies and Self Assessment Tests
Lecture 106Access to Case study directory
Section 15Drug Registration in ASEAN countries (Optional)
Lecture 107ASEAN Drug Regulatory Affairs
Lecture 108Asean Geography
Lecture 109Drug Registration in Brunei
Lecture 110Drug Registration in Malaysia
Lecture 111Drug Registration in Cambodia
Lecture 112Drug Registration in Mayanmar
Lecture 113Drug Registration in Philippines
Lecture 114Drug Registration in Singapore
Section 16CDSCO : Drug Registration in India (Optional)
Lecture 115Drug Regulation in India - CDSCO
Lecture 116National Pharmaceutical Pricing Authority
Lecture 117Drug Price Regulation in India
Lecture 118Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 119Drug Price Control Order 2013
Lecture 120Case Study of New Drug Approval in India
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