TypeOnline Course
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Price$650 / Rs. 32500
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Regulatory Affairs Course Comparison

View course content comparison of 1 Week / 1 month / 1 Year program in drug regulatory affairs. This will help you to choose right regulatory affairs course which suits to your requirement.

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Introduction

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Eligibility

Admission Process

Course Deliverables

Course Comparison

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

View course content comparison of 1 Week / 1 month / 1 Year program in drug regulatory affairs. This will help you to choose right regulatory affairs course which suits to your requirement.

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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 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 
Lecture 19Patent & Exclusivity - Strategic Understanding | Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 2Clinical Trial / Research - Fundamental
Lecture 20Clinical Trial Detailed Study (Topic - 1-11)
Lecture 21Clinical Trial Protocol Writing
Lecture 22Ethics in Clinical Research
Lecture 23Informed Consent
Lecture 24FDA forms and How to fill FDA forms
Lecture 25Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 26Clinical Trial Failure: Lack of Efficacy - Case Study
Lecture 27Clinical Trial Failure: Lack of Efficacy - Case Study
Section 3IPR Related Topics (Optional)
Lecture 28USPTO - Introduction
Lecture 29Patent - Fundamental Concepts
Lecture 30Patent Application Process - USPTO
Lecture 31Trademark Search and Registration in US
Lecture 32Steps Know How & Key Points - Patent Application
Lecture 33IPR - Patent Grant and Handling Process in India (Optional)
Lecture 34Patent Search in Indian Patent Office (Optional)
Lecture 35Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 36Trademark Search assignment (optional)
Lecture 37Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 38Regulatory Strategies in different phases of Clinical Trial
Lecture 39Advance study on Para IV Filing
Lecture 40Para IV Notice
Lecture 41Evergreening - Patent Life Extension Strategies
Lecture 42Pay For Delay Strategy
Lecture 43REMS Strategic Planning
Lecture 44Compulsory Licensing
Lecture 45Technology Licensing
Lecture 46In-Licensing Vs. Outlicensing
Lecture 47LOE Strategies for Innovator Brands with case study
Lecture 48Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 49Drug Re-purposing
Lecture 50Practical Queries on different USFDA application and Filing 
Section 5GMP
Lecture 51Definition of GMP
Lecture 52Certification Pharmaceutical Companies / Plants
Lecture 53Introduction to Good Manufacturing Practices
Lecture 54Premises & Plant Layout Designing
Lecture 55Sanitation and Hygiene
Lecture 56Equipment
Lecture 57Production Modules
Lecture 58GMP Documentation
Lecture 59Quality Control
Lecture 60Handling of Product Complaint
Lecture 61GMP Storage
Lecture 62ISO and ISO Audits
Lecture 63Pharmaceutical SOPs
Lecture 64SOP Automation
Section 6Drug Master File & Site Master File
Lecture 65Key Consideration for Drug Master File Preparation and Submission 
Lecture 66Practical Understanding on Drug Master File Preparation and Submission
Lecture 67Site Master File - Detailed Understanding 
Lecture 68DMF Completeness Assessment
Lecture 69Drug Master File - Fees
Lecture 70Drug Master File - Global Perspective [Across Different Regions]
Section 7Biopharmaceutical Regulation [Innovator & Biosimilar]
Lecture 71Introduction : Biopharmaceuticals
Lecture 72Classification of Biopharmaceutical 
Lecture 73Introduction to Biosimilar 
Lecture 74Chemical Drugs Vs. Biologic Drugs
Lecture 75Principle of Naming of Biologics
Lecture 76Current Trends in Biopharmaceutical Market
Lecture 77Present Encouraging Factors for Biopharmaceutical Industry
Lecture 78Complexity of biopharma supply chain and operations
Lecture 79Biopharma Market Segmentation
Lecture 80Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 81Recombinant protein
Lecture 82Monoclonal Antibodies
Lecture 83Synthetic Immunomodulators
Lecture 84Production of Monoclonal Antibodies
Lecture 85Cytokines
Lecture 86Interferon
Lecture 87Erythropoiesis-stimulating agent
Lecture 88Biological Licensing Application (BLA) 
Lecture 89Biosimilar Approval process
Lecture 90Vaccine development and approval Process
Lecture 91Review : 351(a) vs. 351(k) pathway
Lecture 92Biosimilar Development Process
Lecture 93Strategic Consideration for Biosimilar Development 
Lecture 94Bio-Manufacturing Process Information
Section 8Data Integrity and Consequences : Effective Management of Data Integrity Issues
Lecture 95Data Integrity issues in Pharmaceutical Industry
Lecture 96EIR | 483 Observations | Warning Letter | Handling of FDA inspection
Lecture 97Handling of warning letter
Lecture 98Case Study: Warning Letter
Lecture 99CAPA - Importance and principle
Lecture 100Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 9Drug Registration in European Country (Optional)
Lecture 101Overview of EU Regulation
Lecture 102Orientation to European Countries and National Regulatory Bodies
Lecture 103Overview of EU Regulation
Lecture 104EMEA Procedures
Lecture 105Summary of Product Characteristics (SmPC)
Lecture 106Compassionate Use
Lecture 107MHRA - UK Regulation
Lecture 108EU Orphan Medicinal Products Regulation
Lecture 109The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 110Regulatory Implementation on Unique identifier & anti-tampering device on pharmaceutical packaging
Section 10GCC Regulatory Affairs (Optional)
Lecture 111Regions in Pharma Business : Common Terminologies
Lecture 112GCC Pharma Market
Lecture 113GCC Export
Lecture 114GCC Registration Procedure
Lecture 115Drug Registration in Saudi Arabia
Lecture 116Documentation Required for the GCC countries
Lecture 117Drug Registration in Beherain, UAE, Kuwait, Qatar, Oman
Lecture 118Medical Device Regulation in GCC countries
Section 11Innovator Drug Registration Dossier and Generic Submission
Lecture 119Introduction to Common Technical Document (CTD)
Lecture 120CMC Dossier & Compliance Management
Lecture 121ECTD
Lecture 122Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 123Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 124Review on Stability Testing
Lecture 125Black Box Warning
Lecture 126Importance of effective dossier management
Lecture 127Deficiencies observed in CTD Dossiers
Lecture 128Certificate of Analysis
Lecture 129Detailed Understanding on ANDA Submission Dossier 
Lecture 130Prior Approval Submission 
Lecture 131Detailed Understanding on ANDA Fees
Lecture 132505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 133NCE Vs. 505b2 application - Case Based Learning 
Lecture 134FTF - 180 Days Exclusivity - Case Based Learning
Lecture 135Classic case study of the 505b2 filing
Lecture 136Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 137Asean Common Technical Document (ACTD) 
Lecture 138Discussion on 85 common deficiency in CTD submission dossier
Section 12Portfolio Management and Related Topics
Lecture 139Advance understanding of the portfolio Management
Lecture 140Importance of market research in pharmaceutical industry
Lecture 141Co-promotion & Co-marketing strategy in pharma industry
Lecture 142Concept of Reverse co-promotion in pharma industry
Lecture 143Publication Management from Regulatory perspective
Lecture 144Juxtapid Case Study
Lecture 145New Indication Approval Process and Promotion
Lecture 146OTC Switch
Lecture 147Practical Case Study in Rx to OTC Switch
Section 13API Regulatory Affairs
Section 14Case Study Access
Lecture 14948 different topics of the Regulatory Affairs, Case Studies and Self Assessment Tests
Lecture 150Access to Case study directory
Section 15Drug Registration in ASEAN countries (Optional)
Lecture 151ASEAN Drug Regulatory Affairs
Lecture 152Asean Geography
Lecture 153Drug Registration in Brunei
Lecture 154Drug Registration in Malaysia
Lecture 155Drug Registration in Cambodia
Lecture 156Drug Registration in Mayanmar
Lecture 157Drug Registration in Philippines
Lecture 158Drug Registration in Singapore
Section 16CDSCO : Drug Registration in India (Optional)
Lecture 159Drug Regulation in India - CDSCO
Lecture 160National Pharmaceutical Pricing Authority
Lecture 161Drug Price Regulation in India
Lecture 162Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 163Drug Price Control Order 2013
Lecture 164Case Study of New Drug Approval in India
Section 17Final Examination
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