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Executive Program in Global Drug Regulatory Affairs





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global drug regulatory affairs

Executive Program in Global Drug Regulatory Affairs course provides practical knowledge on functionalities of Regulatory Manager. This unique self paced training covers General Drug Regulatory Affairs with advance regional Drug Regulatory Affairs in a single bridged program. Therefore, one can get the entire knowledge of  drug regulatory affairs in a single program. 

Code: KPE-C-103

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

Course Objectives:

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

  • 24×7 self paced online learning  – learn at your convenience. 
  • Courses can be accessed at your own convenient time.
  • Downloadable PDF study modules.
  • E-lectures for easy understanding of the concepts.
  • Self assessment concept checkers for each lecture. 
  • Simulation to real life working. 
  • Access to case studies. 
  • Unique personalized course tracking page with course performance analytics. 
  • Flexible online final examination (Computer Based Test by secure mode).  
  • Course certification –  Course completion and Course gradation certificate will be issued.

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 provides comprehensive training on drug regulatory affairs. A unique self paced training covers General Drug Regulatory Affairs with advanced Regional Drug Regulatory Affairs in a single bridged program. Therefore, one can get the entire knowledge of Regulatory Affairs. 

executive drug regulatory affairs course

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.
  • Japan Drug Regulatory Affairs

Executive DRA – Course Deliverable

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Department / Functional Area

Pharma Global Business – Executive Program

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DRA + PMT Dual Specialization

RA, PMT, Strategic Management and International Marketing Professionals

European Drug Regulatory Affairs

RA – EU, handling regulated market.

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RA / BD professionals handling GCC market.

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RA / BD professionals handling African continent.

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RA / BD professional handling ASEAN market

Latam Regulatory Affairs Course

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RA / BD professional handling Middle East + GCC market

MENA Drug Regulatory Affairs

RA / BD professional handling MENA market Middle East + North Africa + GCC market

Drug Dossier Preparation

RA / QA / QC / Production Management professionals

DMF and SMF preparation

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ANDA Filing and Strategic Management

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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 | Practical Training on preparing ICF | Ready Templates
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 3Innovation Management in Pharmaceutical and Biopharmaceutical Organization
Lecture 31Introduction to intellectual Property Management
Lecture 32Patent - Fundamental Concepts
Lecture 33Understanding on Patent System | TRIPS agreement | Process Patent | Product Patent
Lecture 34Patent Grant and Managing Patent Filing Procedure
Lecture 35Scope of Patentability
Lecture 36IPR - Patent Grant and Handling Process in India
Lecture 37Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 38Patent search in Indian Patent office
Lecture 39Difference in US and European Patent
Lecture 40Patent Claim | Types of Patent Claim
Lecture 41Patent Cliff | How to calculate the expected sales after patent cliff
Lecture 42Terminologies related to patent, trademark, copyright and licensing 
Lecture 43Patent Infringement
Lecture 44Introduction to Trademark | Trademark filing procedure
Lecture 45Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 46Trademark Infringement | Passing off | Practical Cases
Lecture 47Trademark Classes | How to search the right trademark class for for filing trademark application
Section 4Regulatory Strategies
Lecture 48Regulatory Strategies in different phases of Clinical Trial
Lecture 49Advance study on Para IV Filing
Lecture 50Para IV Notice
Lecture 51Evergreening - Patent Life Extension Strategies
Lecture 52Pay For Delay Strategy
Lecture 53REMS Strategic Planning
Lecture 54Compulsory Licensing
Lecture 55Technology Licensing
Lecture 56In-Licensing Vs. Outlicensing
Lecture 57LOE Strategies for Innovator Brands with case study
Lecture 58Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 59Drug Re-purposing
Lecture 60Advance understanding of the portfolio Management 
Lecture 61Publication Management from Regulatory perspective
Lecture 62New Indication Approval Process and Promotion 
Lecture 63OTC Switch 
Lecture 64OTC Switch : Case Study
Section 5GMP
Lecture 65Certification Pharmaceutical Companies / Plants
Lecture 66Premises & Plant Layout Designing
Lecture 67Sanitation and Hygiene
Lecture 68Equipment
Lecture 69Production Modules
Lecture 70GMP Documentation
Lecture 71Quality Control
Lecture 72Handling of Product Complaint
Lecture 73GMP Storage
Lecture 74ISO and ISO Audits
Lecture 75Pharmaceutical SOPs | SOP Automation
Lecture 76Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Section 6Drug Master File & Site Master File
Lecture 77Key Consideration for Drug Master File Preparation and Submission 
Lecture 78Practical Understanding on Drug Master File Preparation and Submission
Lecture 79Site Master File - Detailed Understanding 
Lecture 80DMF Completeness Assessment
Lecture 81Drug Master File - Fees
Lecture 82Drug Master File - Global Perspective [Across Different Regions]
Section 7Biopharmaceutical Regulation [Innovator & Biosimilar]
Lecture 83Introduction : Biopharmaceuticals
Lecture 84Classification of Biopharmaceutical 
Lecture 85Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 86Chemical Drugs Vs. Biologic Drugs
Lecture 87Principle of Naming of Biologics
Lecture 88Current Trends in Biopharmaceutical Market
Lecture 89Present Encouraging Factors for Biopharmaceutical Industry
Lecture 90Complexity of biopharma supply chain and operations
Lecture 91Biopharma Market Segmentation
Lecture 92Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 93Recombinant protein
Lecture 94Monoclonal Antibodies
Lecture 95Synthetic Immunomodulators
Lecture 96Production of Monoclonal Antibodies
Lecture 97Cytokines
Lecture 98Interferon
Lecture 99Erythropoiesis-stimulating agent
Lecture 100Biological Licensing Application (BLA) 
Lecture 101Biosimilar Approval process
Lecture 102Vaccine development and approval Process
Lecture 103Review : 351(a) vs. 351(k) pathway
Lecture 104Biosimilar Development Process
Lecture 105Strategic Consideration for Biosimilar Development 
Lecture 106Bio-Manufacturing Process Information
Lecture 107Juxtapid Case Study
Section 8Drug Registration in European Country
Lecture 108Overview of EU Regulation
Lecture 109Orientation to European Countries and National Regulatory Bodies
Lecture 110EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 111Overview of EU Regulation 
Lecture 112EMA and EMA Authorisation Process
Lecture 113EU MA Application Types and Strategic Planning
Lecture 114EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 115EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 116Validity 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 117Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 118EU Orphan Medicinal Products Regulation
Lecture 119Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 120Summary of Product Characteristics 
Lecture 121Compassionate Use
Lecture 122MHRA - UK Regulation 
Lecture 123The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 124Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 125EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 126EU Prime Designation
Lecture 127EMA - Accelerated assessment
Lecture 128EU Adaptive Pathway
Lecture 129European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 130SPOR  - Concept of Master Data Management  
Section 9Innovator Drug Registration Dossier and Generic Submission
Lecture 131Introduction to Common Technical Document (CTD)
Lecture 132Asean Common Technical Document (ACTD)
Lecture 133ECTD
Lecture 134Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 135Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 136Black Box Warning
Lecture 137Importance of effective dossier management
Lecture 138Deficiencies observed in CTD Dossiers
Lecture 139Certificate of Analysis
Lecture 140Detailed Understanding on ANDA Submission Dossier 
Lecture 141Prior Approval Submission 
Lecture 142Detailed Understanding on ANDA Fees
Lecture 143505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 144NCE Vs. 505b2 application - Case Based Learning 
Lecture 145FTF - 180 Days Exclusivity - Case Based Learning
Lecture 146Classic case study of the 505b2 filing
Lecture 147Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 148Discussion on 85 common deficiency in CTD submission dossier
Lecture 149Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 150Data Integrity issues in Pharmaceutical Industry
Lecture 151Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 152Asean Common Technical Document (ACTD) 
Lecture 153Climate Zone
Lecture 154Stability Zone Finder
Lecture 155Stability Studies : Case discussions
Lecture 156Stability Data for Zone IV countries
Lecture 157Accelerated and Intermediate Testing Conditions
Lecture 158Long Term Stability Testing Requirements
Lecture 159Stability Study Protocol Development - Dosage form: Capsule
Lecture 160Dossier Stability Test
Lecture 161Dossier Stability Test
Lecture 162Testing Frequency
Lecture 163Bracketing
Lecture 164Matrixing
Lecture 165PDE Value | Importance, Significance | How to calculate PDE value 
Lecture 166RTQs | Response to Queries | How to handle Regulatory Queries 
Lecture 167Introduction to Variation Management | Reasons for Variation | Working in Variation Department | Changes falls under variation
Lecture 168Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Section 10Bioequivalence Study
Lecture 169PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 170Bioequivalence Study | Study design | Different types of BE Studies
Lecture 171Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalization | Confidence interval acceptance criteria
Lecture 172Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 173Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 174Bioequivalence Study - Discussion - Dissolution Testing
Lecture 175Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 11Drug Registration in ASEAN countries
Lecture 176Introduction to ASEAN Drug Regulatory Affairs
Lecture 177ASEAN Geography -
Lecture 178ASEAN countries drug regulatory bodies
Lecture 179ACTRs | ACTD requirements | Other Key Factors specific to individual ASEAN countries
Lecture 180The Pharmaceutical Inspection Co-operation Scheme
Lecture 181CPP Requirements for Drug Registration in ASEAN countries
Lecture 182Dossier Requirements - ACTD/CTD Acceptability
Lecture 183Pharmacopoeias Acceptability in ASEAN drug registration process
Lecture 184Harmonization of Technical Guidelines 
Lecture 185Stability Study
Lecture 186Guideline on Product Labeling
Lecture 187Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 188Pharmacovigilance and Risk Management Plan (RMP)
Lecture 189Timeline of Drug Registration Approval
Lecture 190ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 191Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 192Drug Registration and Regulation in Brunei
Lecture 193Drug Registration and Regulation in Cambodia
Section 12Drug Registration in African Countries
Lecture 194African Continent Overview - Brief introduction to course
Lecture 195African Pharma Market
Lecture 196Drug Registration - African medicines regulatory
Lecture 197Basic Export Requirement for African Countries
Lecture 198Export Documentations & Important Concepts
Lecture 199Nigeria  - Drug Registration
Lecture 200Drug Registration in Algeria
Lecture 201Drug Registration in Ethiopia
Lecture 202Drug Registration in Kenya
Lecture 203Drug Registration in Egypt
Lecture 204Drug Registration in Ghana
Lecture 205Drug Registration in Botswana
Lecture 206Drug Registration and Regulation in Uganda
Lecture 207Drug Registration and Regulation in Zambia
Section 13Drug Registration in Latin America
Lecture 208Download Study Modules
Lecture 209Different Business Regions and terminologies
Lecture 210Introduction to Latin American Pharma market
Lecture 211Drug Registration and Regulation in Argentina 
Lecture 212Drug Registration and Regulation in Bolivia
Lecture 213Drug Registration and Regulation in Brazil
Lecture 214Drug Registration and Regulation in Chile
Lecture 215Drug Registration and Regulation in Colombia
Lecture 216Drug Registration and Regulation in Mexico
Lecture 217Drug regulation and registration in Peru
Section 14Data Integrity and Consequences : Effective Management of Data Integrity Issues
Lecture 218Data Integrity issues in Pharmaceutical Industry
Lecture 219Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 220CAPA
Section 15Drug Registration and Regulation in GCC countries
Lecture 221Introduction to GCC Pharmaceutical Market 
Lecture 222GCC - Centralized Vs. Decentralized Registration Process
Lecture 223Drug Registration in Saudi Arabia
Lecture 224Drug Registration in UAE
Lecture 225Drug Registration in Kuwait
Lecture 226Drug Registration in Bahrain
Lecture 227Drug Registration in Oman
Lecture 228Documentation Required for the GCC countries 
Section 16Drug Registration and Regulation in China
Lecture 229Drug Registration and Regulation in China
Lecture 230New Update: NMPA's the Drug Registration Regulation (DRR) and the Drug Manufacturing Regulation (DMR) update on July, 2020
Section 17Reference
Lecture 231Comparison of Requirement of Various Regulatory Bodies
Lecture 232Comparison of Dossier Requirements of Europe and US
Lecture 233Comparison of DMF requirement of various regulatory bodies
Section 18Drug Registration and Regulation in Russia
Section 19Final Examination
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