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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. Am 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

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 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


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Executive DRA – Course Deliverable

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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  • This course comes with 2 credit of add on certification course. Hence, participants of Executive Program in Drug Regulatory Affairs will receive two add on certification. One – 1 month course and also one 1-week course.
  • 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 | 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 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 53Certification Pharmaceutical Companies / Plants
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 97EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 98Overview of EU Regulation 
Lecture 99EMA and EMA Authorisation Process
Lecture 100EU MA Application Types and Strategic Planning
Lecture 101EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 102EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 103Validity 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 104Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 105EU Orphan Medicinal Products Regulation
Lecture 106Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 107Summary of Product Characteristics 
Lecture 108Compassionate Use
Lecture 109MHRA - UK Regulation 
Lecture 110The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 111Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 112EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 113EU Prime Designation
Lecture 114EMA - Accelerated assessment
Lecture 115EU Adaptive Pathway
Lecture 116European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 117SPOR  - Concept of Master Data Management  
Section 9Innovator Drug Registration Dossier and Generic Submission
Lecture 118Introduction to Common Technical Document (CTD)
Lecture 119Asean Common Technical Document (ACTD)
Lecture 120ECTD
Lecture 121Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 122Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
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
Lecture 135Discussion on 85 common deficiency in CTD submission dossier
Lecture 136Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 137Data Integrity issues in Pharmaceutical Industry
Lecture 138Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 139Asean Common Technical Document (ACTD) 
Section 10Portfolio Management and Related Topics
Lecture 140Advance understanding of the portfolio Management
Lecture 141Importance of market research in pharmaceutical industry
Lecture 142Co-promotion & Co-marketing strategy in pharma industry
Lecture 143Concept of Reverse co-promotion in pharma industry
Lecture 144Publication Management from Regulatory perspective
Lecture 145Juxtapid Case Study
Lecture 146New Indication Approval Process and Promotion
Lecture 147OTC Switch
Lecture 148Practical Case Study in Rx to OTC Switch
Section 11Drug Registration in ASEAN countries
Lecture 149ASEAN Drug Regulatory Affairs
Lecture 150Asean Geography
Lecture 151Drug Registration in Brunei
Lecture 152Drug Registration in Malaysia
Lecture 153Drug Registration in Cambodia
Lecture 154Drug Registration in Mayanmar
Lecture 155Drug Registration in Philippines
Lecture 156Drug Registration in Singapore
Section 12Drug Registration in African Countries
Lecture 157African Continent Overview - Brief introduction to course
Lecture 158African Pharma Market
Lecture 159Drug Registration - African medicines regulatory
Lecture 160Basic Export Requirement for African Countries
Lecture 161Export Documentations & Important Concepts
Lecture 162Nigeria  - Drug Registration
Lecture 163Drug Registration in Algeria
Lecture 164Drug Registration in Ethiopia
Lecture 165Drug Registration in Kenya
Lecture 166Drug Registration in Egypt
Lecture 167Drug Registration in Ghana
Lecture 168Drug Registration in Botswana
Lecture 169Drug Registration and Regulation in Uganda
Lecture 170Drug Registration and Regulation in Zambia
Section 13Drug Registration in Latin America
Lecture 171Download Study Modules
Lecture 172Different Business Regions and terminologies
Lecture 173Introduction to Latin American Pharma market
Lecture 174Drug Registration and Regulation in Argentina 
Lecture 175Drug Registration and Regulation in Bolivia
Lecture 176Drug Registration and Regulation in Brazil
Lecture 177Drug Registration and Regulation in Chile
Lecture 178Drug Registration and Regulation in Colombia
Lecture 179Drug Registration and Regulation in Mexico
Section 14Data Integrity and Consequences : Effective Management of Data Integrity Issues
Lecture 180Data Integrity issues in Pharmaceutical Industry
Lecture 181Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 182CAPA
Section 15Drug Registration and Regulation in GCC countries
Lecture 183Introduction to GCC Pharmaceutical Market 
Lecture 184GCC - Centralized Vs. Decentralized Registration Process
Lecture 185Drug Registration in Saudi Arabia
Lecture 186Drug Registration in UAE
Lecture 187Drug Registration in Kuwait
Lecture 188Drug Registration in Bahrain
Lecture 189Drug Registration in Oman
Lecture 190Documentation Required for the GCC countries 
Section 16Drug Registration and Regulation in China
Lecture 191Drug Registration and Regulation in China
Lecture 192New Update: NMPA's the Drug Registration Regulation (DRR) and the Drug Manufacturing Regulation (DMR) update on July, 2020
Section 17Reference
Lecture 193Comparison of Requirement of Various Regulatory Bodies
Lecture 194Comparison of Dossier Requirements of Europe and US
Lecture 195Comparison of DMF requirement of various regulatory bodies
Section 18Drug Registration and Regulation in Russia
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