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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

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.

Drug Regulatory Affairs Related Courses


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Pharma Global Business – Executive Program

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Biologic Regulatory Affairs

DRA + Pharmacovigilance Dual Specialization

RA and Pharmacovigilance

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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.

GCC Drug Regulatory Affairs

RA / BD professionals handling GCC market.

African Drug Regulatory Affairs

RA / BD professionals handling African continent.

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RA / BD professional handling ASEAN market

Latam Regulatory Affairs Course

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Middle East Drug Regulatory Affairs

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

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DMF and SMF preparation

RA / QA / QC / Production Management professionals

ANDA Filing and Strategic Management

RA / QA / QC / Production Management professionals

Japan Drug Regulatory Affairs

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China Drug Regulatory Affairs

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Drug Registration and Regulation UAE

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Medical Device Related Courses


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US market RA / BD professionals.

CE Certification

Medical Device RA / BD professionals.

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
Section 5GMP
Lecture 60Certification Pharmaceutical Companies / Plants
Lecture 61Premises & Plant Layout Designing
Lecture 62Sanitation and Hygiene
Lecture 63Equipment
Lecture 64Production Modules
Lecture 65GMP Documentation
Lecture 66Quality Control
Lecture 67Handling of Product Complaint
Lecture 68GMP Storage
Lecture 69ISO and ISO Audits
Lecture 70Pharmaceutical SOPs
Lecture 71SOP Automation
Section 6Drug Master File & Site Master File
Lecture 72Key Consideration for Drug Master File Preparation and Submission 
Lecture 73Practical Understanding on Drug Master File Preparation and Submission
Lecture 74Site Master File - Detailed Understanding 
Lecture 75DMF Completeness Assessment
Lecture 76Drug Master File - Fees
Lecture 77Drug Master File - Global Perspective [Across Different Regions]
Section 7Biopharmaceutical Regulation [Innovator & Biosimilar]
Lecture 78Introduction : Biopharmaceuticals
Lecture 79Classification of Biopharmaceutical 
Lecture 80Introduction to Biosimilar 
Lecture 81Chemical Drugs Vs. Biologic Drugs
Lecture 82Principle of Naming of Biologics
Lecture 83Current Trends in Biopharmaceutical Market
Lecture 84Present Encouraging Factors for Biopharmaceutical Industry
Lecture 85Complexity of biopharma supply chain and operations
Lecture 86Biopharma Market Segmentation
Lecture 87Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 88Recombinant protein
Lecture 89Monoclonal Antibodies
Lecture 90Synthetic Immunomodulators
Lecture 91Production of Monoclonal Antibodies
Lecture 92Cytokines
Lecture 93Interferon
Lecture 94Erythropoiesis-stimulating agent
Lecture 95Biological Licensing Application (BLA) 
Lecture 96Biosimilar Approval process
Lecture 97Vaccine development and approval Process
Lecture 98Review : 351(a) vs. 351(k) pathway
Lecture 99Biosimilar Development Process
Lecture 100Strategic Consideration for Biosimilar Development 
Lecture 101Bio-Manufacturing Process Information
Section 8Drug Registration in European Country
Lecture 102Overview of EU Regulation
Lecture 103Orientation to European Countries and National Regulatory Bodies
Lecture 104EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 105Overview of EU Regulation 
Lecture 106EMA and EMA Authorisation Process
Lecture 107EU MA Application Types and Strategic Planning
Lecture 108EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 109EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 110Validity 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 111Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 112EU Orphan Medicinal Products Regulation
Lecture 113Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 114Summary of Product Characteristics 
Lecture 115Compassionate Use
Lecture 116MHRA - UK Regulation 
Lecture 117The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 118Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 119EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 120EU Prime Designation
Lecture 121EMA - Accelerated assessment
Lecture 122EU Adaptive Pathway
Lecture 123European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 124SPOR  - Concept of Master Data Management  
Section 9Innovator Drug Registration Dossier and Generic Submission
Lecture 125Introduction to Common Technical Document (CTD)
Lecture 126Asean Common Technical Document (ACTD)
Lecture 127ECTD
Lecture 128Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 129Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 130Black Box Warning
Lecture 131Importance of effective dossier management
Lecture 132Deficiencies observed in CTD Dossiers
Lecture 133Certificate of Analysis
Lecture 134Detailed Understanding on ANDA Submission Dossier 
Lecture 135Prior Approval Submission 
Lecture 136Detailed Understanding on ANDA Fees
Lecture 137505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 138NCE Vs. 505b2 application - Case Based Learning 
Lecture 139FTF - 180 Days Exclusivity - Case Based Learning
Lecture 140Classic case study of the 505b2 filing
Lecture 141Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 142Discussion on 85 common deficiency in CTD submission dossier
Lecture 143Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 144Data Integrity issues in Pharmaceutical Industry
Lecture 145Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 146Asean Common Technical Document (ACTD) 
Section 10Portfolio Management and Related Topics
Lecture 147Advance understanding of the portfolio Management
Lecture 148Importance of market research in pharmaceutical industry
Lecture 149Co-promotion & Co-marketing strategy in pharma industry
Lecture 150Concept of Reverse co-promotion in pharma industry
Lecture 151Publication Management from Regulatory perspective
Lecture 152Juxtapid Case Study
Lecture 153New Indication Approval Process and Promotion
Lecture 154OTC Switch
Lecture 155Practical Case Study in Rx to OTC Switch
Section 11Drug Registration in ASEAN countries
Lecture 156Introduction to ASEAN Drug Regulatory Affairs
Lecture 157ASEAN Geography -
Lecture 158ASEAN countries drug regulatory bodies
Lecture 159ACTRs | ACTD requirements | Other Key Factors specific to individual ASEAN countries
Lecture 160The Pharmaceutical Inspection Co-operation Scheme
Lecture 161CPP Requirements for Drug Registration in ASEAN countries
Lecture 162Dossier Requirements - ACTD/CTD Acceptability
Lecture 163Pharmacopoeias Acceptability in ASEAN drug registration process
Lecture 164Harmonization of Technical Guidelines 
Lecture 165Stability Study
Lecture 166Guideline on Product Labeling
Lecture 167Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 168Pharmacovigilance and Risk Management Plan (RMP)
Lecture 169Timeline of Drug Registration Approval
Lecture 170ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 171Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 172Drug Registration and Regulation in Brunei
Lecture 173Drug Registration and Regulation in Cambodia
Section 12Drug Registration in African Countries
Lecture 174African Continent Overview - Brief introduction to course
Lecture 175African Pharma Market
Lecture 176Drug Registration - African medicines regulatory
Lecture 177Basic Export Requirement for African Countries
Lecture 178Export Documentations & Important Concepts
Lecture 179Nigeria  - Drug Registration
Lecture 180Drug Registration in Algeria
Lecture 181Drug Registration in Ethiopia
Lecture 182Drug Registration in Kenya
Lecture 183Drug Registration in Egypt
Lecture 184Drug Registration in Ghana
Lecture 185Drug Registration in Botswana
Lecture 186Drug Registration and Regulation in Uganda
Lecture 187Drug Registration and Regulation in Zambia
Section 13Drug Registration in Latin America
Lecture 188Download Study Modules
Lecture 189Different Business Regions and terminologies
Lecture 190Introduction to Latin American Pharma market
Lecture 191Drug Registration and Regulation in Argentina 
Lecture 192Drug Registration and Regulation in Bolivia
Lecture 193Drug Registration and Regulation in Brazil
Lecture 194Drug Registration and Regulation in Chile
Lecture 195Drug Registration and Regulation in Colombia
Lecture 196Drug Registration and Regulation in Mexico
Section 14Data Integrity and Consequences : Effective Management of Data Integrity Issues
Lecture 197Data Integrity issues in Pharmaceutical Industry
Lecture 198Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 199CAPA
Section 15Drug Registration and Regulation in GCC countries
Lecture 200Introduction to GCC Pharmaceutical Market 
Lecture 201GCC - Centralized Vs. Decentralized Registration Process
Lecture 202Drug Registration in Saudi Arabia
Lecture 203Drug Registration in UAE
Lecture 204Drug Registration in Kuwait
Lecture 205Drug Registration in Bahrain
Lecture 206Drug Registration in Oman
Lecture 207Documentation Required for the GCC countries 
Section 16Drug Registration and Regulation in China
Lecture 208Drug Registration and Regulation in China
Lecture 209New Update: NMPA's the Drug Registration Regulation (DRR) and the Drug Manufacturing Regulation (DMR) update on July, 2020
Section 17Reference
Lecture 210Comparison of Requirement of Various Regulatory Bodies
Lecture 211Comparison of Dossier Requirements of Europe and US
Lecture 212Comparison of DMF requirement of various regulatory bodies
Section 18Drug Registration and Regulation in Russia
Section 19Final Examination
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