TypeOnline Course
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Price$650 / Rs. 32500
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Admission Process

Admission Process

Upon receiving your filled up application form, our admin team will generate PROVISIONAL ADMISSION ID and send you the PROVISIONAL ADMISSION LETTER along with instruction to course fees payment options.

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Introduction

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Eligibility

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 Takeda, Pfizer, GSK, Lipoxen (UK), Patheon, Mylan, Biocon, Micro Lab, GE Lifesciences, Orchid, Sanofi, AstraZeneca, Hospira, Ranbaxy, Julphar, Jhonson and Jhonson, Ethicon, Dr. Reddy’s Laboratory, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, 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, Wintac Limited, Faveo Pharmaceuticals, Enzem, Leo Pharma, Accenture, Shaigan Pharmaceutical, Ceutica & Chemie, Medxplor Healthcare, Systopic Laboratories and many more companies across the pharma industry.

  • 24×7 Online Access – Access anytime from anywhere across globe.
  • 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. 
  • Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage. 
  • Flexible online final examination (Computer Based Test by secure mode)
  • Access to 1000s of real life case studies

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.

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ADMISSION PROCESS

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 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Authorized Generics: Key Understanding
Lecture 13Exploratory IND
Lecture 14Patents Vs. exclusivity
Lecture 15Case Study New Drug Development & R&D Incentive Plans
Lecture 16Submission Requirements for Orphan Drug Designation
Lecture 17Advance Learning on 505B2 Pathway
Lecture 18Chemistry, Manufacturing & Controls 
Section 2Clinical Trial / Research - Fundamental
Lecture 19Clinical Trial Detailed Study (Topic - 1-11)
Lecture 20Clinical Trial Protocol Writing
Lecture 21Ethics in Clinical Research
Lecture 22Informed Consent
Lecture 23FDA forms and How to fill FDA forms
Lecture 24Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 25Clinical Trial Failure: Lack of Efficacy - Case Study
Lecture 26Clinical Trial Failure: Lack of Efficacy - Case Study
Section 3IPR Related Topics (Optional)
Lecture 27USPTO - Introduction
Lecture 28Patent - Fundamental Concepts
Lecture 29Patent Application Process - USPTO
Lecture 30Trademark Search and Registration in US
Lecture 31Steps Know How & Key Points - Patent Application
Lecture 32IPR - Patent Grant and Handling Process in India (Optional)
Lecture 33Patent Search in Indian Patent Office (Optional)
Lecture 34Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 35Trademark Search assignment (optional)
Lecture 36Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 37Regulatory Strategies in different phases of Clinical Trial
Lecture 38Advance study on Para IV Filing
Lecture 39Para IV Notice
Lecture 40Evergreening - Patent Life Extension Strategies
Lecture 41Pay For Delay Strategy
Lecture 42REMS Strategic Planning
Lecture 43Compulsory Licensing
Lecture 44Technology Licensing
Lecture 45In-Licensing Vs. Outlicensing
Lecture 46LOE Strategies for Innovator Brands with case study
Lecture 47Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 48Drug Re-purposing
Lecture 49Practical Queries on different USFDA application and Filing 
Section 5GMP
Lecture 50Definition of GMP
Lecture 51Certification Pharmaceutical Companies / Plants
Lecture 52Introduction to Good Manufacturing Practices
Lecture 53Premises & Plant Layout Designing
Lecture 54Sanitation and Hygiene
Lecture 55Equipment
Lecture 56Production Modules
Lecture 57GMP Documentation
Lecture 58Quality Control
Lecture 59Handling of Product Complaint
Lecture 60GMP Storage
Lecture 61ISO and ISO Audits
Lecture 62Pharmaceutical SOPs
Lecture 63SOP Automation
Section 6Drug Master File & Site Master File
Lecture 64Key Consideration for Drug Master File Preparation and Submission 
Lecture 65Practical Understanding on Drug Master File Preparation and Submission
Lecture 66Site Master File - Detailed Understanding 
Lecture 67DMF Completeness Assessment
Lecture 68Drug Master File - Fees
Lecture 69Drug Master File - Global Perspective [Across Different Regions]
Section 7Biopharmaceutical Regulation [Innovator & Biosimilar]
Lecture 70Introduction : Biopharmaceuticals
Lecture 71Classification of Biopharmaceutical 
Lecture 72Introduction to Biosimilar 
Lecture 73Chemical Drugs Vs. Biologic Drugs
Lecture 74Principle of Naming of Biologics
Lecture 75Current Trends in Biopharmaceutical Market
Lecture 76Present Encouraging Factors for Biopharmaceutical Industry
Lecture 77Complexity of biopharma supply chain and operations
Lecture 78Biopharma Market Segmentation
Lecture 79Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 80Recombinant protein
Lecture 81Monoclonal Antibodies
Lecture 82Synthetic Immunomodulators
Lecture 83Production of Monoclonal Antibodies
Lecture 84Cytokines
Lecture 85Interferon
Lecture 86Erythropoiesis-stimulating agent
Lecture 87Biological Licensing Application (BLA) 
Lecture 88Biosimilar Approval process
Lecture 89Vaccine development and approval Process
Lecture 90Review : 351(a) vs. 351(k) pathway
Lecture 91Biosimilar Development Process
Lecture 92Strategic Consideration for Biosimilar Development 
Lecture 93Bio-Manufacturing Process Information
Section 8Data Integrity and Consequences : Effective Management of Data Integrity Issues
Lecture 94Data Integrity issues in Pharmaceutical Industry
Lecture 95USFDA Warning Letter
Lecture 96Handling of warning letter
Lecture 97Case Study: Warning Letter
Lecture 98CAPA
Section 9Drug Registration in European Country (Optional)
Lecture 99Overview of EU Regulation
Lecture 100Orientation to European Countries and National Regulatory Bodies
Lecture 101Overview of EU Regulation
Lecture 102EMEA Procedures
Lecture 103Summary of Product Characteristics (SmPC)
Lecture 104Compassionate Use
Lecture 105MHRA - UK Regulation
Lecture 106EU Orphan Medicinal Products Regulation
Lecture 107The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 108Regulatory Implementation on Unique identifier & anti-tampering device on pharmaceutical packaging
Section 10GCC Regulatory Affairs (Optional)
Lecture 109Regions in Pharma Business : Common Terminologies
Lecture 110GCC Pharma Market
Lecture 111GCC Export
Lecture 112GCC Registration Procedure
Lecture 113Drug Registration in Saudi Arabia
Lecture 114Documentation Required for the GCC countries
Lecture 115Drug Registration in Beherain, UAE, Kuwait, Qatar, Oman
Lecture 116Medical Device Regulation in GCC countries
Section 11Innovator Drug Registration Dossier and Generic Submission
Lecture 117Introduction to Common Technical Document (CTD)
Lecture 118CMC Dossier & Compliance Management
Lecture 119ECTD
Lecture 120Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 121Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 122Review on Stability Testing
Lecture 123Black Box Warning
Lecture 124Importance of effective dossier management
Lecture 125Deficiencies observed in CTD Dossiers
Lecture 126Certificate of Analysis
Lecture 127Detailed Understanding on ANDA Submission Dossier 
Lecture 128Prior Approval Submission 
Lecture 129Detailed Understanding on ANDA Fees
Lecture 130505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 131NCE Vs. 505b2 application - Case Based Learning 
Lecture 132FTF - 180 Days Exclusivity - Case Based Learning
Lecture 133Classic case study of the 505b2 filing
Lecture 134Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 135Asean Common Technical Document (ACTD) 
Lecture 136Discussion on 85 common deficiency in CTD submission dossier
Section 12Portfolio Management and Related Topics
Lecture 137Advance understanding of the portfolio Management
Lecture 138Importance of market research in pharmaceutical industry
Lecture 139Co-promotion & Co-marketing strategy in pharma industry
Lecture 140Concept of Reverse co-promotion in pharma industry
Lecture 141Publication Management from Regulatory perspective
Lecture 142Juxtapid Case Study
Lecture 143New Indication Approval Process and Promotion
Lecture 144OTC Switch
Lecture 145Practical Case Study in Rx to OTC Switch
Section 13API Regulatory Affairs
Section 14Case Study Access
Lecture 14748 different topics of the Regulatory Affairs, Case Studies and Self Assessment Tests
Lecture 148Access to Case study directory
Section 15Drug Registration in ASEAN countries (Optional)
Lecture 149ASEAN Drug Regulatory Affairs
Lecture 150Asean Geography
Lecture 151Drug Registration in Brunei
Lecture 152Drug Registration in Malaysia
Lecture 153Drug Registration in Cambodia
Lecture 154Drug Registration in Mayanmar
Lecture 155Drug Registration in Philippines
Lecture 156Drug Registration in Singapore
Section 16CDSCO : Drug Registration in India (Optional)
Lecture 157Drug Regulation in India - CDSCO
Lecture 158National Pharmaceutical Pricing Authority
Lecture 159Drug Price Regulation in India
Lecture 160Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 161Drug Price Control Order 2013
Lecture 162Case Study of New Drug Approval in India
Section 17Final Examination
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