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Global Drug Regulatory Affairs





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Course Code: KPE-C-103

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

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.

Features of the course

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 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-

Executive Program in Global Drug Regulatory Affairs

Executive Program in Global Drug Regulatory Affairs provides comprehensive training on drug regulatory affairs. A uniquely designed self paced training covers General Drug Regulatory Affairs and also Regional Drug Regulatory Affairs in a single bridged program. Therefore, one can get the entire knowledge of Regulatory Affairs. 

executive drug regulatory affairs

General Drug Regulatory Affairs 

  • Fundamental to Drug Discovery Development to Commercialization
  • Clinical Research – Advance Learning
  • IPR strategic planning – Patent, Trademarking. Patent and trademark filing, registration, objection, opposition handling process. Patent Term Extension, Patent Term Restoration.
  • Marketing Authorization Process and strategic pathways for pharmaceuticals, Biopharmaceutical products. 
  • Generic Drug and Innovator Molecule’s Marketing Authorization Process
  • ANDA preparation and filing  – ANDA submission, Para IV filing, first to file. 
  • Portfolio Management – case based learning – Training on Loss of Exclusivity Management, Evergreening tools and techniques. Various strategic planning. 
  • GMP – GMP training, GMP Audits, 483 observations, warning letter, data integrity, SOP Management, CAPA
  • Stability study – Requirements, types of stability study, management of stability studies and requirements.
  • Variation Management – Authorization management, regional differences. 
  • DMF preparation and filing, SMF preparation and filing
  • Drug Dossier Preparation, filing and management of the dossier for different product classes. 
  • Advance training on biopharmaceutical – innovator and biosimilar regulatory pathway

Regional Drug Regulatory Affairs 

  • US FDA Drug Regulatory Affairs
  • European Regulatory Affairs [Post Brexit]
  • Middle East + GCC countries regulatory affairs 
  • ASEAN drug regulatory affairs
  • African drug regulatory affairs
  • LATAM drug regulatory affairs
  • BRIC – Brazil, Russia, China, India,  drug regulatory affairs.


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  • The participants of Global Business Registrant will get one add on certification.
  • Participant can choose add on courses of any 1 month or 1 week certification course.
  • There will be no fees  for add on courses and courses can be opted any time during the main course access period.
  • On completion of add on course, participant will be issuing course certificate.

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 6Complete Response Letter | Key understanding | Management and Action Plan
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
Lecture 19Chemistry, Manufacturing & Controls 
Lecture 20Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 21Review on Drug Discovery and Development 
Section 2Clinical Trial / Research - Fundamental
Lecture 22Clinical Trial Detailed Study (Topic - 1-11)
Lecture 23Clinical Trial Protocol Writing
Lecture 24Ethics in Clinical Research
Lecture 25Informed Consent
Lecture 26FDA forms and How to fill FDA forms
Lecture 27Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 28Clinical Trial Failure: Lack of Efficacy - Case Study
Lecture 29Clinical Trial Failure: Lack of Efficacy - Case Study
Lecture 30Importance and Significance of Phase 2b Clinical Trial 
Section 3IPR Related Topics (Optional)
Lecture 31USPTO - Introduction
Lecture 32Patent - Fundamental Concepts
Lecture 33Patent Application Process - USPTO
Lecture 34Trademark Search and Registration in US
Lecture 35Steps Know How & Key Points - Patent Application
Lecture 36IPR - Patent Grant and Handling Process in India (Optional)
Lecture 37Patent Search in Indian Patent Office (Optional)
Lecture 38Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 39Trademark Search assignment (optional)
Lecture 40Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 41Regulatory Strategies in different phases of Clinical Trial
Lecture 42Advance study on Para IV Filing
Lecture 43Para IV Notice
Lecture 44Evergreening - Patent Life Extension Strategies
Lecture 45Pay For Delay Strategy
Lecture 46REMS Strategic Planning
Lecture 47Compulsory Licensing
Lecture 48Technology Licensing
Lecture 49In-Licensing Vs. Outlicensing
Lecture 50LOE Strategies for Innovator Brands with case study
Lecture 51Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 52Drug Re-purposing
Section 5GMP
Lecture 53Definition of GMP
Lecture 54Certification Pharmaceutical Companies / Plants
Lecture 55Introduction to Good Manufacturing Practices
Lecture 56Premises & Plant Layout Designing
Lecture 57Sanitation and Hygiene
Lecture 58Equipment
Lecture 59Production Modules
Lecture 60GMP Documentation
Lecture 61Quality Control
Lecture 62Handling of Product Complaint
Lecture 63GMP Storage
Lecture 64ISO and ISO Audits
Lecture 65Pharmaceutical SOPs
Lecture 66SOP Automation
Section 6Drug Master File & Site Master File
Lecture 67Key Consideration for Drug Master File Preparation and Submission 
Lecture 68Practical Understanding on Drug Master File Preparation and Submission
Lecture 69Site Master File - Detailed Understanding 
Lecture 70DMF Completeness Assessment
Lecture 71Drug Master File - Fees
Lecture 72Drug Master File - Global Perspective [Across Different Regions]
Section 7Biopharmaceutical Regulation [Innovator & Biosimilar]
Lecture 73Introduction : Biopharmaceuticals
Lecture 74Classification of Biopharmaceutical 
Lecture 75Introduction to Biosimilar 
Lecture 76Chemical Drugs Vs. Biologic Drugs
Lecture 77Principle of Naming of Biologics
Lecture 78Current Trends in Biopharmaceutical Market
Lecture 79Present Encouraging Factors for Biopharmaceutical Industry
Lecture 80Complexity of biopharma supply chain and operations
Lecture 81Biopharma Market Segmentation
Lecture 82Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 83Recombinant protein
Lecture 84Monoclonal Antibodies
Lecture 85Synthetic Immunomodulators
Lecture 86Production of Monoclonal Antibodies
Lecture 87Cytokines
Lecture 88Interferon
Lecture 89Erythropoiesis-stimulating agent
Lecture 90Biological Licensing Application (BLA) 
Lecture 91Biosimilar Approval process
Lecture 92Vaccine development and approval Process
Lecture 93Review : 351(a) vs. 351(k) pathway
Lecture 94Biosimilar Development Process
Lecture 95Strategic Consideration for Biosimilar Development 
Lecture 96Bio-Manufacturing Process Information
Section 8Drug Registration in European Country
Lecture 97Overview of EU Regulation
Lecture 98Orientation to European Countries and National Regulatory Bodies
Lecture 99EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 100Overview of EU Regulation 
Lecture 101EMA and EMA Authorisation Process
Lecture 102EU MA Application Types and Strategic Planning
Lecture 103EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 104EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 105Validity of the EU MA  - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 106Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 107EU Orphan Medicinal Products Regulation
Lecture 108Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 109Summary of Product Characteristics 
Lecture 110Compassionate Use
Lecture 111MHRA - UK Regulation 
Lecture 112The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 113Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 114EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 115EU Prime Designation
Lecture 116EMA - Accelerated assessment
Lecture 117EU Adaptive Pathway
Lecture 118European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 119SPOR  - Concept of Master Data Management  
Section 9Innovator Drug Registration Dossier and Generic Submission
Lecture 120Introduction to Common Technical Document (CTD)
Lecture 121Asean Common Technical Document (ACTD)
Lecture 122ECTD
Lecture 123Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 124Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
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 137Discussion on 85 common deficiency in CTD submission dossier
Lecture 138Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 139Data Integrity issues in Pharmaceutical Industry
Lecture 140Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 10Portfolio Management and Related Topics
Lecture 141Advance understanding of the portfolio Management
Lecture 142Importance of market research in pharmaceutical industry
Lecture 143Co-promotion & Co-marketing strategy in pharma industry
Lecture 144Concept of Reverse co-promotion in pharma industry
Lecture 145Publication Management from Regulatory perspective
Lecture 146Juxtapid Case Study
Lecture 147New Indication Approval Process and Promotion
Lecture 148OTC Switch
Lecture 149Practical Case Study in Rx to OTC Switch
Section 11Drug Registration in ASEAN countries
Lecture 150ASEAN Drug Regulatory Affairs
Lecture 151Asean Geography
Lecture 152Drug Registration in Brunei
Lecture 153Drug Registration in Malaysia
Lecture 154Drug Registration in Cambodia
Lecture 155Drug Registration in Mayanmar
Lecture 156Drug Registration in Philippines
Lecture 157Drug Registration in Singapore
Section 12CDSCO : Drug Registration in India
Lecture 158Drug Regulation in India - CDSCO
Lecture 159National Pharmaceutical Pricing Authority
Lecture 160Drug Price Regulation in India
Lecture 161Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 162Drug Price Control Order 2013
Lecture 163Case Study of New Drug Approval in India
Section 13Drug Registration in African Countries
Lecture 164African Continent Overview - Brief introduction to course
Lecture 165African Pharma Market
Lecture 166Drug Registration - African medicines regulatory
Lecture 167Basic Export Requirement for African Countries
Lecture 168Export Documentations & Important Concepts
Lecture 169Nigeria  - Drug Registration
Lecture 170Drug Registration in Algeria
Lecture 171Drug Registration in Ethiopia
Lecture 172Drug Registration in Kenya
Lecture 173Drug Registration in Egypt
Lecture 174Drug Registration in Ghana
Lecture 175Drug Registration in Botswana
Section 14Drug Registration in Latin America
Lecture 176Download Study Modules
Lecture 177Different Business Regions and terminologies
Lecture 178Introduction to Latin American Pharma market
Lecture 179Drug Registration and Regulation in Argentina 
Lecture 180Drug Registration and Regulation in Bolivia
Lecture 181Drug Registration and Regulation in Brazil
Lecture 182Drug Registration and Regulation in Chile
Lecture 183Drug Registration and Regulation in Colombia
Lecture 184Drug Registration and Regulation in Mexico
Section 15Data Integrity and Consequences : Effective Management of Data Integrity Issues
Lecture 185Data Integrity issues in Pharmaceutical Industry
Lecture 186Warning Letter
Lecture 187CAPA
Section 16Drug Registration and Regulation in GCC countries
Lecture 188Introduction to GCC Pharmaceutical Market 
Lecture 189GCC - Centralized Vs. Decentralized Registration Process
Lecture 190Drug Registration in Saudi Arabia
Lecture 191Drug Registration in UAE
Lecture 192Drug Registration in Kuwait
Lecture 193Drug Registration in Bahrain
Lecture 194Drug Registration in Oman
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