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Admission Process

Admission Process

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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


Frequently asked questions

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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 
Section 2Clinical Trial / Research - Fundamental
Lecture 20Clinical Trial Detailed Study (Topic - 1-11)
Lecture 21Clinical Trial Protocol Writing
Lecture 22Ethics in Clinical Research
Lecture 23Informed Consent
Lecture 24FDA forms and How to fill FDA forms
Lecture 25Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 26Clinical Trial Failure: Lack of Efficacy - Case Study
Lecture 27Clinical Trial Failure: Lack of Efficacy - Case Study
Section 3IPR Related Topics (Optional)
Lecture 28USPTO - Introduction
Lecture 29Patent - Fundamental Concepts
Lecture 30Patent Application Process - USPTO
Lecture 31Trademark Search and Registration in US
Lecture 32Steps Know How & Key Points - Patent Application
Lecture 33IPR - Patent Grant and Handling Process in India (Optional)
Lecture 34Patent Search in Indian Patent Office (Optional)
Lecture 35Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 36Trademark Search assignment (optional)
Lecture 37Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 38Regulatory Strategies in different phases of Clinical Trial
Lecture 39Advance study on Para IV Filing
Lecture 40Para IV Notice
Lecture 41Evergreening - Patent Life Extension Strategies
Lecture 42Pay For Delay Strategy
Lecture 43REMS Strategic Planning
Lecture 44Compulsory Licensing
Lecture 45Technology Licensing
Lecture 46In-Licensing Vs. Outlicensing
Lecture 47LOE Strategies for Innovator Brands with case study
Lecture 48Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 49Drug Re-purposing
Section 5GMP
Lecture 50Definition of GMP
Lecture 51Certification Pharmaceutical Companies / Plants
Lecture 52Introduction to Good Manufacturing Practices
Lecture 53Premises & Plant Layout Designing
Lecture 54Sanitation and Hygiene
Lecture 55Equipment
Lecture 56Production Modules
Lecture 57GMP Documentation
Lecture 58Quality Control
Lecture 59Handling of Product Complaint
Lecture 60GMP Storage
Lecture 61ISO and ISO Audits
Lecture 62Pharmaceutical SOPs
Lecture 63SOP Automation
Section 6Drug Master File & Site Master File
Lecture 64Key Consideration for Drug Master File Preparation and Submission 
Lecture 65Practical Understanding on Drug Master File Preparation and Submission
Lecture 66Site Master File - Detailed Understanding 
Lecture 67DMF Completeness Assessment
Lecture 68Drug Master File - Fees
Lecture 69Drug Master File - Global Perspective [Across Different Regions]
Section 7Biopharmaceutical Regulation [Innovator & Biosimilar]
Lecture 70Introduction : Biopharmaceuticals
Lecture 71Classification of Biopharmaceutical 
Lecture 72Introduction to Biosimilar 
Lecture 73Chemical Drugs Vs. Biologic Drugs
Lecture 74Principle of Naming of Biologics
Lecture 75Current Trends in Biopharmaceutical Market
Lecture 76Present Encouraging Factors for Biopharmaceutical Industry
Lecture 77Complexity of biopharma supply chain and operations
Lecture 78Biopharma Market Segmentation
Lecture 79Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 80Recombinant protein
Lecture 81Monoclonal Antibodies
Lecture 82Synthetic Immunomodulators
Lecture 83Production of Monoclonal Antibodies
Lecture 84Cytokines
Lecture 85Interferon
Lecture 86Erythropoiesis-stimulating agent
Lecture 87Biological Licensing Application (BLA) 
Lecture 88Biosimilar Approval process
Lecture 89Vaccine development and approval Process
Lecture 90Review : 351(a) vs. 351(k) pathway
Lecture 91Biosimilar Development Process
Lecture 92Strategic Consideration for Biosimilar Development 
Lecture 93Bio-Manufacturing Process Information
Section 8Drug Registration in European Country
Lecture 94Overview of EU Regulation
Lecture 95Orientation to European Countries and National Regulatory Bodies
Lecture 96Overview of EU Regulation
Lecture 97EMEA Procedures
Lecture 98Summary of Product Characteristics (SmPC)
Lecture 99Compassionate Use
Lecture 100MHRA - UK Regulation
Lecture 101EU Orphan Medicinal Products Regulation
Lecture 102The 'sunset clause' for marketing authorisations of pharmaceuticals
Section 9Innovator Drug Registration Dossier and Generic Submission
Lecture 103Introduction to Common Technical Document (CTD)
Lecture 104Asean Common Technical Document (ACTD)
Lecture 105ECTD
Lecture 106Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 107Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 108Black Box Warning
Lecture 109Importance of effective dossier management
Lecture 110Deficiencies observed in CTD Dossiers
Lecture 111Certificate of Analysis
Lecture 112Detailed Understanding on ANDA Submission Dossier 
Lecture 113Prior Approval Submission 
Lecture 114Detailed Understanding on ANDA Fees
Lecture 115505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 116NCE Vs. 505b2 application - Case Based Learning 
Lecture 117FTF - 180 Days Exclusivity - Case Based Learning
Lecture 118Classic case study of the 505b2 filing
Lecture 119Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 120Discussion on 85 common deficiency in CTD submission dossier
Lecture 121Data Integrity issues in Pharmaceutical Industry
Section 10Portfolio Management and Related Topics
Lecture 122Advance understanding of the portfolio Management
Lecture 123Importance of market research in pharmaceutical industry
Lecture 124Co-promotion & Co-marketing strategy in pharma industry
Lecture 125Concept of Reverse co-promotion in pharma industry
Lecture 126Publication Management from Regulatory perspective
Lecture 127Juxtapid Case Study
Lecture 128New Indication Approval Process and Promotion
Lecture 129OTC Switch
Lecture 130Practical Case Study in Rx to OTC Switch
Section 11Drug Registration in ASEAN countries
Lecture 131ASEAN Drug Regulatory Affairs
Lecture 132Asean Geography
Lecture 133Drug Registration in Brunei
Lecture 134Drug Registration in Malaysia
Lecture 135Drug Registration in Cambodia
Lecture 136Drug Registration in Mayanmar
Lecture 137Drug Registration in Philippines
Lecture 138Drug Registration in Singapore
Section 12CDSCO : Drug Registration in India
Lecture 139Drug Regulation in India - CDSCO
Lecture 140National Pharmaceutical Pricing Authority
Lecture 141Drug Price Regulation in India
Lecture 142Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 143Drug Price Control Order 2013
Lecture 144Case Study of New Drug Approval in India
Section 13Drug Registration in African Countries
Lecture 145African Continent Overview - Brief introduction to course
Lecture 146African Pharma Market
Lecture 147Drug Registration - African medicines regulatory
Lecture 148Basic Export Requirement for African Countries
Lecture 149Export Documentations & Important Concepts
Lecture 150Nigeria  - Drug Registration
Lecture 151Drug Registration in Algeria
Lecture 152Drug Registration in Ethiopia
Lecture 153Drug Registration in Kenya
Lecture 154Drug Registration in Egypt
Lecture 155Drug Registration in Ghana
Lecture 156Drug Registration in Botswana
Section 14Drug Registration in Latin America
Lecture 157Download Study Modules
Lecture 158Different Business Regions and terminologies
Lecture 159Introduction to Latin American Pharma market
Lecture 160Drug Registration and Regulation in Argentina 
Lecture 161Drug Registration and Regulation in Bolivia
Lecture 162Drug Registration and Regulation in Brazil
Lecture 163Drug Registration and Regulation in Chile
Lecture 164Drug Registration and Regulation in Colombia
Lecture 165Drug Registration and Regulation in Mexico
Section 15Data Integrity and Consequences : Effective Management of Data Integrity Issues
Lecture 166Data Integrity issues in Pharmaceutical Industry
Lecture 167Warning Letter
Lecture 168CAPA
Section 16Drug Registration and Regulation in GCC countries
Lecture 169Introduction to GCC Pharmaceutical Market 
Lecture 170GCC - Centralized Vs. Decentralized Registration Process
Lecture 171Drug Registration in Saudi Arabia
Lecture 172Drug Registration in UAE
Lecture 173Drug Registration in Kuwait
Lecture 174Drug Registration in Bahrain
Lecture 175Drug Registration in Oman
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