TypeOnline Course
Student Enrolled4
Price$790 / 38500 INR
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This online course covers comprehensively total drug regulatory affairs syllabus and medical devices regulatory affairs in a single course. 

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 34Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 5Advance Regulatory Strategies
Lecture 35Regulatory Strategies in different phases of Clinical Trial
Lecture 36Advance study on Para IV Filing
Lecture 37Para IV Notices
Lecture 38Evergreening
Lecture 39Pay For Delay Strategy
Lecture 40REMS Strategic Planning 
Lecture 41Compulsory Licensing
Lecture 42Licensing & Technology Transfer
Lecture 43In-Licensing Vs. Outlicensing
Lecture 44LOE Strategies for Innovator Brands with case study
Lecture 45Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 46Drug Repurposing
Lecture 47What is the meaning of first to file generics?
Section 6Plant GMP and related Topics
Lecture 48Definition of GMP
Lecture 49Certification Pharmaceutical Companies / Plants
Lecture 50Introduction to Good Manufacturing Practices
Lecture 51Premises & Plant Layout Designing
Lecture 52Sanitation and Hygiene
Lecture 53Equipment Modules
Lecture 54Production Modules
Lecture 55Documentation
Lecture 56Quality Control
Lecture 57Product Complaint
Lecture 58Storage Module
Lecture 59Pharmaceutical SOPs Management from regulatory perspective
Section 7Drug Master File & Site Master File
Lecture 60Key Consideration for Drug Master File Preparation and Submission 
Lecture 61Practical Understanding on Drug Master File Preparation and Submission
Lecture 62Site Master File - Detailed Understanding 
Lecture 63DMF Completeness Assessment
Lecture 64Drug Master File - Fees
Lecture 65Drug Master File - Global Perspective
Section 8Drug Dossier Preparation and Submission
Lecture 66Common Technical Document (CTD)
Lecture 67Electronic Common Technical Document (ECTD)
Lecture 68Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 69Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 70Black Box Warning
Lecture 71Importance of effective dossier management
Lecture 72Deficiencies observed in CTD Dossiers
Lecture 73Certificate of Analysis
Lecture 74Detailed Understanding on ANDA Submission Dossier 
Lecture 75Prior Approval Submission (PAS) for ANDA
Lecture 76Detailed Understanding on ANDA Fees
Lecture 77Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 78NCE Vs. 505b2 application - Case Based Learning 
Lecture 79FTF - 180 Days Exclusivity - Case Based Learning
Lecture 80Classic case study of the 505b2 filing : Case Based Learning
Lecture 81Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 82Chemistry, Manufacturing & Controls  - Fundamental Understanding
Lecture 83Chemistry, Manufacturing & Controls 
Lecture 84CMC Dossier & Compliance Management
Lecture 85Discussion on 85 common deficiency in CTD submission dossier
Section 9EU regulation
Lecture 86Introduction to EU Regulation 
Lecture 87Orientation to European Countries and National Regulatory Bodies
Lecture 88EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 89Overview of EU Regulation 
Lecture 90EMA and EMA Authorisation Process
Lecture 91Compassionate Use
Lecture 92EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 93EU Orphan Medicinal Products Regulation
Lecture 94Validity 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 95Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 96EU Orphan Medicinal Products Regulation
Lecture 97Conditional marketing authorisation
Lecture 98Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 99Summary of Product Characteristics 
Lecture 100Compassionate Use
Lecture 101MHRA - UK Regulation 
Lecture 102The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 103Accelerated assessment by EMEA
Lecture 104Master Data Maintenance by EMEA
Lecture 105EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 106EU Adaptive Pathway
Lecture 107European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 108SPOR  - Concept of Master Data Management  
Section 10Biopharmaceutical [Biotech & Biosimilar Regulation]
Lecture 109Introduction : Biopharmaceuticals
Lecture 110Classification of Biopharmaceutical 
Lecture 111Introduction to Biosimilar
Lecture 112Chemical Drugs Vs. Biologic Drugs
Lecture 113Principle of Naming of Biologics
Lecture 114Current Trends in Biopharmaceutical Market
Lecture 115Present Encouraging Factors for Biopharmaceutical Industry
Lecture 116Complexity of biopharma supply chain and operations
Lecture 117Biopharma Market Segmentation
Lecture 118Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 119Recombinant protein
Lecture 120Monoclonal Antibodies
Lecture 121Synthetic Immunomodulators
Lecture 122Production of Monoclonal Antibodies
Lecture 123Cytokines
Lecture 124Interferon
Lecture 125Erythropoiesis-stimulating agent
Lecture 126Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 127Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 128Vaccine development and approval Process
Lecture 129Purple Book: Significance | Searching | Assignments
Lecture 130Biosimilar Development Process
Lecture 131Strategic Consideration for Biosimilar Development 
Lecture 132Bio-Manufacturing Process
Lecture 133Studies required for approval of biosimilar
Section 11Medical Device Regulation
Lecture 134Medical Device Regulation - Introduction
Lecture 135Definition of Medical Device
Lecture 136Classification of Medical Devices
Lecture 137Medical Devices Classification : Work File 
Lecture 138Review Test
Lecture 139510k - Pre-market Notification
Lecture 140FDA decision making process for different classes of 510k applications
Lecture 141Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 142FDA decision making process for different classes of 510k applications
Lecture 143Review Test
Lecture 144PMA - Quality System
Lecture 145PMA Labelling
Lecture 146Investigational Device Exemption
Lecture 147PMA Postapproval Requirements
Lecture 148Postmarket Surveillance Studies
Lecture 149PMA Supplements and Amendments
Lecture 150Expedited review of devices
Lecture 151Expiration Dating
Lecture 152Device Master Files
Lecture 153Unapproved use of Medical Devices 
Lecture 154Marketing, Advertising and Promotion of Medical Devices
Lecture 155FDA 513(g) Submission
Lecture 156De Novo Petition 
Lecture 157Humanitarian Device Exemption (HDE)
Lecture 158Combination Products
Lecture 159Premarket Review and Postmarket Regulation of Combination Products
Lecture 160Medical Devices Regulation in Canada
Lecture 161EU regulation on medical devices
Lecture 162Quality Management System (QMS) for medical devices
Lecture 163c-GMP Requirement for Medical Devices
Lecture 164Medical Devices Regulation in India
Lecture 165CE Marking : Practical Understanding - Requirements and Process
Lecture 166Techinical Dossier for Medical Devices
Lecture 167ISO 13485:2016 - Process Guidance
Lecture 168Medical Devices Recall - Classification and Procedure
Section 12USFDA Warning Letter and Data Integrity and Related Topics
Lecture 169Data Integrity issues in Pharmaceutical Industry
Lecture 170Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 171Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 13FINAL EXAMINATION
Lecture 172DRA FINAL EXAMINATION
Lecture 173MDRA FINAL EXAMINATION