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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


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View comparison of 1 Week / 1 month / 1 Year program Drug Regulatory Affairs course content comparison. This will help you to select the right regulatory affairs program.

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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 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
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
Section 2Clinical Trial / Research - Fundamental
Lecture 21Clinical Trial Detailed Study (Topic - 1-11)
Lecture 22Clinical Trial Protocol Writing
Lecture 23Ethics in Clinical Research
Lecture 24Informed Consent
Lecture 25FDA forms and How to fill FDA forms
Lecture 26Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 27Clinical Trial Failure: Lack of Efficacy - Case Study
Lecture 28Clinical Trial Failure: Lack of Efficacy - Case Study
Section 3IPR Related Topics (Optional)
Lecture 29USPTO - Introduction
Lecture 30Patent - Fundamental Concepts
Lecture 31Patent Application Process - USPTO
Lecture 32Trademark Search and Registration in US
Lecture 33Steps Know How & Key Points - Patent Application
Lecture 34IPR - Patent Grant and Handling Process in India (Optional)
Lecture 35Patent Search in Indian Patent Office (Optional)
Lecture 36Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 37Trademark Search assignment (optional)
Lecture 38Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 39Regulatory Strategies in different phases of Clinical Trial
Lecture 40Advance study on Para IV Filing
Lecture 41Para IV Notice
Lecture 42Evergreening - Patent Life Extension Strategies
Lecture 43Pay For Delay Strategy
Lecture 44REMS Strategic Planning
Lecture 45Compulsory Licensing
Lecture 46Technology Licensing
Lecture 47In-Licensing Vs. Outlicensing
Lecture 48LOE Strategies for Innovator Brands with case study
Lecture 49Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 50Drug Re-purposing
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 8Drug Registration in European Country
Lecture 95Overview of EU Regulation
Lecture 96Orientation to European Countries and National Regulatory Bodies
Lecture 97Overview of EU Regulation
Lecture 98EMEA Procedures
Lecture 99Summary of Product Characteristics (SmPC)
Lecture 100Compassionate Use
Lecture 101MHRA - UK Regulation
Lecture 102EU Orphan Medicinal Products Regulation
Lecture 103The 'sunset clause' for marketing authorisations of pharmaceuticals
Section 9Innovator Drug Registration Dossier and Generic Submission
Lecture 104Introduction to Common Technical Document (CTD)
Lecture 105Asean Common Technical Document (ACTD)
Lecture 106ECTD
Lecture 107Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 108Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 109Black Box Warning
Lecture 110Importance of effective dossier management
Lecture 111Deficiencies observed in CTD Dossiers
Lecture 112Certificate of Analysis
Lecture 113Detailed Understanding on ANDA Submission Dossier 
Lecture 114Prior Approval Submission 
Lecture 115Detailed Understanding on ANDA Fees
Lecture 116505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 117NCE Vs. 505b2 application - Case Based Learning 
Lecture 118FTF - 180 Days Exclusivity - Case Based Learning
Lecture 119Classic case study of the 505b2 filing
Lecture 120Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 121Discussion on 85 common deficiency in CTD submission dossier
Lecture 122Data Integrity issues in Pharmaceutical Industry
Section 10Portfolio Management and Related Topics
Lecture 123Advance understanding of the portfolio Management
Lecture 124Importance of market research in pharmaceutical industry
Lecture 125Co-promotion & Co-marketing strategy in pharma industry
Lecture 126Concept of Reverse co-promotion in pharma industry
Lecture 127Publication Management from Regulatory perspective
Lecture 128Juxtapid Case Study
Lecture 129New Indication Approval Process and Promotion
Lecture 130OTC Switch
Lecture 131Practical Case Study in Rx to OTC Switch
Section 11Drug Registration in ASEAN countries
Lecture 132ASEAN Drug Regulatory Affairs
Lecture 133Asean Geography
Lecture 134Drug Registration in Brunei
Lecture 135Drug Registration in Malaysia
Lecture 136Drug Registration in Cambodia
Lecture 137Drug Registration in Mayanmar
Lecture 138Drug Registration in Philippines
Lecture 139Drug Registration in Singapore
Section 12CDSCO : Drug Registration in India
Lecture 140Drug Regulation in India - CDSCO
Lecture 141National Pharmaceutical Pricing Authority
Lecture 142Drug Price Regulation in India
Lecture 143Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 144Drug Price Control Order 2013
Lecture 145Case Study of New Drug Approval in India
Section 13Drug Registration in African Countries
Lecture 146African Continent Overview - Brief introduction to course
Lecture 147African Pharma Market
Lecture 148Drug Registration - African medicines regulatory
Lecture 149Basic Export Requirement for African Countries
Lecture 150Export Documentations & Important Concepts
Lecture 151Nigeria  - Drug Registration
Lecture 152Drug Registration in Algeria
Lecture 153Drug Registration in Ethiopia
Lecture 154Drug Registration in Kenya
Lecture 155Drug Registration in Egypt
Lecture 156Drug Registration in Ghana
Lecture 157Drug Registration in Botswana
Section 14Drug Registration in Latin America
Lecture 158Download Study Modules
Lecture 159Different Business Regions and terminologies
Lecture 160Introduction to Latin American Pharma market
Lecture 161Drug Registration and Regulation in Argentina 
Lecture 162Drug Registration and Regulation in Bolivia
Lecture 163Drug Registration and Regulation in Brazil
Lecture 164Drug Registration and Regulation in Chile
Lecture 165Drug Registration and Regulation in Colombia
Lecture 166Drug Registration and Regulation in Mexico
Section 15Data Integrity and Consequences : Effective Management of Data Integrity Issues
Lecture 167Data Integrity issues in Pharmaceutical Industry
Lecture 168Warning Letter
Lecture 169CAPA
Section 16Drug Registration and Regulation in GCC countries
Lecture 170Introduction to GCC Pharmaceutical Market 
Lecture 171GCC - Centralized Vs. Decentralized Registration Process
Lecture 172Drug Registration in Saudi Arabia
Lecture 173Drug Registration in UAE
Lecture 174Drug Registration in Kuwait
Lecture 175Drug Registration in Bahrain
Lecture 176Drug Registration in Oman
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