TypeOnline Course
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Price$790 / 38500 INR
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Admission Process

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Course Code: KPE-C-071

Course Title: Advance Diploma in Drug and Medical Devices Regulatory Affairs (DRA + MDRA Dual Specialization)

Course Objective: B.Pharm/D.Pharm/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in Drug or Medical Devices Regulatory Affairs.

Features of the Course:

1. Comprehensive study material covering all important aspects of Drug Regulatory Affairs and Medical Devices Regulatory Affairs

2. Understanding/ Decision Making/ Strategy Creation in the field of regulatory affairs in both pharmaceutical, biopharmaceuticals and medical devices industry.

3. Case Study File for effective skill enhancement for strategic decision making

4. Specialized modules on International Marketing of Pharmaceutical Products and Strategic Management

Course Duration: 1 Year

Nature of the Course: Distance & e-Learning

Course Flow : Course covers comprehensively total drug regulatory affairs syllabus and medical devices regulatory affairs in a single course. 

Section 1Course Study Modules - Download
Section 2Drug Discovery - Development / R&D fundamentals
Lecture 2R&D Process & Introduction to drug discovery
Lecture 3Investigational New Drug Application (INDA)
Lecture 4New Drug Application (NDA) 
Lecture 5Basic concept and understanding of the Generic Drug
Lecture 6Abbreviated New Drug Application (ANDA) 
Lecture 7Complete Response Letter | Key understanding | Management and Action Plan
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Prescription Drug User Fees Act (PDUFA)
Lecture 10Handling of orange book
Lecture 11USFDA expedited programs
Lecture 12Practical Training on INDA, NDA, ANDA filing
Lecture 13505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 14Authorized Generics: Key Understanding
Lecture 15Exploratory IND Vs. Traditional IND
Lecture 16Patents Vs. exclusivity 
Lecture 17Orphan Drug Designation 
Lecture 18Advance Learning on 505B2 Pathway
Lecture 19Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 20Review on Drug Discovery and Development 
Section 3Clinical Trial and Research
Lecture 21Clinical Trial Detailed Study (Topic - 1-11)
Lecture 22Clinical Trial Protocol Writing
Lecture 23Ethics in Clinical Research
Lecture 24FDA Forms and How to fill the resources
Lecture 25Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 4Intellectual Property Management
Lecture 26Functions of the United States Patent and Trademark Office
Lecture 27Patent
Lecture 28Application For Patent - USPTO 
Lecture 29Trademark Search and Registration in US
Lecture 30Steps Know How & Key Points - Patent Application 
Lecture 31IPR - Patent Grant and Handling Process
Lecture 32Patent - Practical on search and filing
Lecture 33Trademark - Practical on TM Search & Registration Process
Lecture 34Trademark Search assignment (optional)
Lecture 35Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 5Advance Regulatory Strategies
Lecture 36Regulatory Strategies in different phases of Clinical Trial
Lecture 37Advance study on Para IV Filing
Lecture 38Para IV Notices
Lecture 39Evergreening
Lecture 40Pay For Delay Strategy
Lecture 41REMS Strategic Planning 
Lecture 42Compulsory Licensing
Lecture 43Licensing & Technology Transfer
Lecture 44In-Licensing Vs. Outlicensing
Lecture 45LOE Strategies for Innovator Brands with case study
Lecture 46Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 47Drug Repurposing
Lecture 48What is the meaning of first to file generics?
Section 6Plant GMP and related Topics
Lecture 49Definition of GMP
Lecture 50Certification Pharmaceutical Companies / Plants
Lecture 51Introduction to Good Manufacturing Practices
Lecture 52Premises & Plant Layout Designing
Lecture 53Sanitation and Hygiene
Lecture 54Equipment Modules
Lecture 55Production Modules
Lecture 56Documentation
Lecture 57Quality Control
Lecture 58Product Complaint
Lecture 59Storage Module
Lecture 60Pharmaceutical SOPs Management from regulatory perspective
Lecture 61SOP Automation in Pharmaceutical Industry
Section 7Drug Master File & Site Master File
Lecture 62Key Consideration for Drug Master File Preparation and Submission 
Lecture 63Practical Understanding on Drug Master File Preparation and Submission
Lecture 64Site Master File - Detailed Understanding 
Lecture 65DMF Completeness Assessment
Lecture 66Drug Master File - Fees
Lecture 67Drug Master File - Global Perspective
Section 8Drug Dossier Preparation and Submission
Lecture 68Common Technical Document (CTD)
Lecture 69Electronic Common Technical Document (ECTD)
Lecture 70Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 71Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 72Black Box Warning
Lecture 73Importance of effective dossier management
Lecture 74Deficiencies observed in CTD Dossiers
Lecture 75Certificate of Analysis
Lecture 76Detailed Understanding on ANDA Submission Dossier 
Lecture 77Prior Approval Submission (PAS) for ANDA
Lecture 78Detailed Understanding on ANDA Fees
Lecture 79Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 80NCE Vs. 505b2 application - Case Based Learning 
Lecture 81FTF - 180 Days Exclusivity - Case Based Learning
Lecture 82Classic case study of the 505b2 filing : Case Based Learning
Lecture 83Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 84Chemistry, Manufacturing & Controls  - Fundamental Understanding
Lecture 85Chemistry, Manufacturing & Controls 
Lecture 86CMC Dossier & Compliance Management
Lecture 87Discussion on 85 common deficiency in CTD submission dossier
Section 9EU regulation
Lecture 88Introduction to EU Regulation 
Lecture 89Orientation to European Countries and National Regulatory Bodies
Lecture 90EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 91Overview of EU Regulation 
Lecture 92EMA and EMA Authorisation Process
Lecture 93Compassionate Use
Lecture 94EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 95EU Orphan Medicinal Products Regulation
Lecture 96Validity 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 97Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 98EU Orphan Medicinal Products Regulation
Lecture 99Conditional marketing authorisation
Lecture 100Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 101Summary of Product Characteristics 
Lecture 102Compassionate Use
Lecture 103MHRA - UK Regulation 
Lecture 104The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 105Accelerated assessment by EMEA
Lecture 106Master Data Maintenance by EMEA
Lecture 107EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 108EU Adaptive Pathway
Lecture 109European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 110SPOR  - Concept of Master Data Management  
Section 10Biopharmaceutical [Biotech & Biosimilar Regulation]
Lecture 111Introduction : Biopharmaceuticals
Lecture 112Classification of Biopharmaceutical 
Lecture 113Introduction to Biosimilar
Lecture 114Chemical Drugs Vs. Biologic Drugs
Lecture 115Principle of Naming of Biologics
Lecture 116Current Trends in Biopharmaceutical Market
Lecture 117Present Encouraging Factors for Biopharmaceutical Industry
Lecture 118Complexity of biopharma supply chain and operations
Lecture 119Biopharma Market Segmentation
Lecture 120Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 121Recombinant protein
Lecture 122Monoclonal Antibodies
Lecture 123Synthetic Immunomodulators
Lecture 124Production of Monoclonal Antibodies
Lecture 125Cytokines
Lecture 126Interferon
Lecture 127Erythropoiesis-stimulating agent
Lecture 128Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 129Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 130Vaccine development and approval Process
Lecture 131Purple Book: Significance | Searching | Assignments
Lecture 132Biosimilar Development Process
Lecture 133Strategic Consideration for Biosimilar Development 
Lecture 134Bio-Manufacturing Process
Lecture 135Studies required for approval of biosimilar
Section 11Medical Device Regulation
Lecture 136Medical Device Regulation - Introduction
Lecture 137Definition of Medical Device
Lecture 138Classification of Medical Devices
Lecture 139Medical Devices Classification : Work File 
Lecture 140Review Test
Lecture 141510k - Pre-market Notification
Lecture 142FDA decision making process for different classes of 510k applications
Lecture 143Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 144FDA decision making process for different classes of 510k applications
Lecture 145Review Test
Lecture 146PMA - Quality System
Lecture 147PMA Labelling
Lecture 148Investigational Device Exemption
Lecture 149PMA Postapproval Requirements
Lecture 150Postmarket Surveillance Studies
Lecture 151PMA Supplements and Amendments
Lecture 152Expedited review of devices
Lecture 153Expiration Dating
Lecture 154Device Master Files
Lecture 155Unapproved use of Medical Devices 
Lecture 156Marketing, Advertising and Promotion of Medical Devices
Lecture 157FDA 513(g) Submission
Lecture 158De Novo Petition 
Lecture 159Humanitarian Device Exemption (HDE)
Lecture 160Combination Products
Lecture 161Premarket Review and Postmarket Regulation of Combination Products
Lecture 162Medical Devices Regulation in Canada
Lecture 163EU regulation on medical devices
Lecture 164Quality Management System (QMS) for medical devices
Lecture 165c-GMP Requirement for Medical Devices
Lecture 166Medical Devices Regulation in India
Lecture 167CE Marking : Practical Understanding - Requirements and Process
Lecture 168Techinical Dossier for Medical Devices
Lecture 169ISO 13485:2016 - Process Guidance
Lecture 170Medical Devices Recall - Classification and Procedure
Section 12USFDA Warning Letter and Data Integrity and Related Topics
Lecture 171Data Integrity issues in Pharmaceutical Industry
Lecture 172Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 173CAPA
Lecture 174Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 13FINAL EXAMINATION
Lecture 175DRA FINAL EXAMINATION
Lecture 176MDRA FINAL EXAMINATION