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Admission Process

Admission Process

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Introduction

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Duration

Eligibility

Learning Areas

Admission Process

Course Code: KPE-C-103

Course Title: Executive Program in Global Drug Regulatory Affairs [EPGDRA]

Course Objectives:

Executive Program in Drug 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.

 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. Printable study modules [PDFs] provided to all course participants. There will be total 28 study modules. 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

1 Year.

B.Pharma/D.Pharma/ B.Sc/ Any graduates or Post Graduates or Phd holder, who want to broaden the career skill in drug regulatory affairs can pursue the course. Minimum 2 years experience required for admission.

Executive Program in Global Drug Regulatory Affairs will be focusing on following-

General DRA

  • Fundamental to Drug Discovery Development to Commercialization
  • Clinical Research – Advance Learning
  • IPR strategic planning – Patent, Trademarking
  • Regulatory Strategic Planning
  • GMP – GMP Audits, 483 observations, data integrity, SOP Management, CAPA
  • DMF preparation and filing
  • SMF preparation and filing
  • ANDA preparatopn and filing
  • Drug Dossier Preparation
  • Advance training on biopharmaceutical – innovator and biosimilar regulatory pathyway
  • Portfolio Maangement – case based learning

Regional DRA

  • Regional DRA
  • European Regulatory Affairs [Post Brexit]
  • GCC Regulatory Affairs
  • ASEAN drug regulatory affairs
  • African drug regulatory affairs
  • LATAM drug regulatory affairs

FAQ RELATED TO 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 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
Lecture 18Advance Learning on 505B2 Pathway
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 !
Section 3IPR Related Topics (Optional)
Lecture 25USPTO - Introduction
Lecture 26Patent - Fundamental Concepts
Lecture 27Patent Application Process - USPTO
Lecture 28Trademark Search and Registration in US
Lecture 29Steps Know How & Key Points - Patent Application
Lecture 30IPR - Patent Grant and Handling Process in India (Optional)
Lecture 31Patent Search in Indian Patent Office (Optional)
Lecture 32Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 33Trademark Search assignment (optional)
Lecture 34Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 35Regulatory Strategies in different phases of Clinical Trial
Lecture 36Advance study on Para IV Filing
Lecture 37Para IV Notice
Lecture 38Evergreening - Patent Life Extension Strategies
Lecture 39Pay For Delay Strategy
Lecture 40REMS Strategic Planning
Lecture 41Compulsory Licensing
Lecture 42Technology Licensing
Lecture 43In-Licensing Vs. Outlicensing
Lecture 44LOE Strategies for Innovator Brands with case study
Lecture 45Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 46Drug Re-purposing
Section 5GMP
Lecture 47Definition of GMP
Lecture 48Certification Pharmaceutical Companies / Plants
Lecture 49Introduction to Good Manufacturing Practices
Lecture 50Premises & Plant Layout Designing
Lecture 51Sanitation and Hygiene
Lecture 52Equipment
Lecture 53Production Modules
Lecture 54GMP Documentation
Lecture 55Quality Control
Lecture 56Handling of Product Complaint
Lecture 57GMP Storage
Lecture 58ISO and ISO Audits
Lecture 59Pharmaceutical SOPs
Lecture 60SOP Automation
Section 6Drug Master File & Site Master File
Lecture 61Key Consideration for Drug Master File Preparation and Submission 
Lecture 62Practical Understanding on Drug Master File Preparation and Submission
Lecture 63Site Master File - Detailed Understanding 
Lecture 64DMF Completeness Assessment
Lecture 65Drug Master File - Fees
Lecture 66Drug Master File - Global Perspective [Across Different Regions]
Section 7Biopharmaceutical Regulation [Innovator & Biosimilar]
Lecture 67Introduction : Biopharmaceuticals
Lecture 68Classification of Biopharmaceutical 
Lecture 69Introduction to Biosimilar 
Lecture 70Chemical Drugs Vs. Biologic Drugs
Lecture 71Principle of Naming of Biologics
Lecture 72Current Trends in Biopharmaceutical Market
Lecture 73Present Encouraging Factors for Biopharmaceutical Industry
Lecture 74Complexity of biopharma supply chain and operations
Lecture 75Biopharma Market Segmentation
Lecture 76Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 77Recombinant protein
Lecture 78Monoclonal Antibodies
Lecture 79Synthetic Immunomodulators
Lecture 80Production of Monoclonal Antibodies
Lecture 81Cytokines
Lecture 82Interferon
Lecture 83Erythropoiesis-stimulating agent
Lecture 84Biological Licensing Application (BLA) 
Lecture 85Biosimilar Approval process
Lecture 86Vaccine development and approval Process
Lecture 87Review : 351(a) vs. 351(k) pathway
Lecture 88Biosimilar Development Process
Lecture 89Strategic Consideration for Biosimilar Development 
Lecture 90Bio-Manufacturing Process Information
Section 8USFDA warning Letter & CAPA
Lecture 91CAPA - Introduction
Lecture 92USFDA Warning Letter
Lecture 93Handling of warning letter
Lecture 94Case Study: Warning Letter
Lecture 95USFDA Inspection Classification – OAI , VAI AND NAI
Section 9Drug Registration in European Country
Lecture 96Overview of EU Regulation
Lecture 97Orientation to European Countries and National Regulatory Bodies
Lecture 98Overview of EU Regulation
Lecture 99EMEA Procedures
Lecture 100Summary of Product Characteristics (SmPC)
Lecture 101Compassionate Use
Lecture 102MHRA - UK Regulation
Lecture 103EU Orphan Medicinal Products Regulation
Lecture 104The 'sunset clause' for marketing authorisations of pharmaceuticals
Section 10GCC Regulatory Affairs (Optional)
Lecture 105Regions in Pharma Business : Common Terminologies
Lecture 106GCC Pharma Market
Lecture 107GCC Export
Lecture 108GCC Registration Procedure
Lecture 109Drug Registration in Saudi Arabia
Lecture 110Documentation Required for the GCC countries
Lecture 111Drug Registration in Beherain, UAE, Kuwait, Qatar, Oman
Lecture 112Medical Device Regulation in GCC countries
Section 11Innovator Drug Registration Dossier and Generic Submission
Lecture 113Introduction to Common Technical Document (CTD)
Lecture 114Asean Common Technical Document (ACTD)
Lecture 115ECTD
Lecture 116Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 117Modules on Stability Study
Lecture 118Stability Study Test
Lecture 119Module on Interchangeability
Lecture 120Stability Testing of API
Lecture 121Stability Testing of Finished Pharmaceutical Products
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
Section 12Portfolio Management and Related Topics
Lecture 135Advance understanding of the portfolio Management
Lecture 136Importance of market research in pharmaceutical industry
Lecture 137Co-promotion & Co-marketing strategy in pharma industry
Lecture 138Concept of Reverse co-promotion in pharma industry
Lecture 139Publication Management from Regulatory perspective
Lecture 140Juxtapid Case Study
Lecture 141New Indication Approval Process and Promotion
Lecture 142OTC Switch
Lecture 143Practical Case Study in Rx to OTC Switch
Section 13Drug Registration in ASEAN countries
Lecture 144ASEAN Drug Regulatory Affairs
Lecture 145Asean Geography
Lecture 146Drug Registration in Brunei
Lecture 147Drug Registration in Malaysia
Lecture 148Drug Registration in Cambodia
Lecture 149Drug Registration in Mayanmar
Lecture 150Drug Registration in Philippines
Lecture 151Drug Registration in Singapore
Section 14CDSCO : Drug Registration in India
Lecture 152Drug Regulation in India - CDSCO
Lecture 153National Pharmaceutical Pricing Authority
Lecture 154Drug Price Regulation in India
Lecture 155Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 156Drug Price Control Order 2013
Lecture 157Case Study of New Drug Approval in India
Section 15Drug Registration in African Countries
Lecture 158African Continent Overview - Brief introduction to course
Lecture 159African Pharma Market
Lecture 160Drug Registration - African medicines regulatory
Lecture 161Basic Export Requirement for African Countries
Lecture 162Export Documentations & Important Concepts
Lecture 163Nigeria  - Drug Registration
Lecture 164Drug Registration in Algeria
Lecture 165Drug Registration in Ethiopia
Lecture 166Drug Registration in Kenya
Lecture 167Drug Registration in Egypt
Lecture 168Drug Registration in Ghana
Lecture 169Drug Registration in Botswana
Section 16Drug Registration in Latin America
Lecture 170Detailed understanding on Latin America Pharmaceutical Market
Lecture 171Drug Registration and Regulation in Argentina
Lecture 172Drug Registration and Regulation in Brazil
Lecture 173Drug Registration and Regulation in Chile
Lecture 174Drug Registration and Regulation in Bolivia
Lecture 175Drug Registration and Regulation in Columbia
Lecture 176Drug Registration and Regulation in Mexico
Lecture 177Drug Registration and Regulation in Peru
Lecture 178Drug Registration and Regulation El Salvador
Lecture 179Drug Registration and Regulation Venezuela
Lecture 180LATAM drug registration requirements comparison analysis
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