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 60ISO and ISO Audits
Lecture 61Pharmaceutical SOPs Management from regulatory perspective
Lecture 62SOP Automation in Pharmaceutical Industry
Section 7Drug Master File & Site Master File
Lecture 63Key Consideration for Drug Master File Preparation and Submission 
Lecture 64Practical Understanding on Drug Master File Preparation and Submission
Lecture 65Site Master File - Detailed Understanding 
Lecture 66DMF Completeness Assessment
Lecture 67Drug Master File - Fees
Lecture 68Drug Master File - Global Perspective
Section 8Drug Dossier Preparation and Submission
Lecture 69Common Technical Document (CTD)
Lecture 70Electronic Common Technical Document (ECTD)
Lecture 71Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 72Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 73Black Box Warning
Lecture 74Importance of effective dossier management
Lecture 75Deficiencies observed in CTD Dossiers
Lecture 76Certificate of Analysis
Lecture 77Detailed Understanding on ANDA Submission Dossier 
Lecture 78Prior Approval Submission (PAS) for ANDA
Lecture 79Detailed Understanding on ANDA Fees
Lecture 80Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 81NCE Vs. 505b2 application - Case Based Learning 
Lecture 82FTF - 180 Days Exclusivity - Case Based Learning
Lecture 83Classic case study of the 505b2 filing : Case Based Learning
Lecture 84Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 85Chemistry, Manufacturing & Controls  - Fundamental Understanding
Lecture 86Chemistry, Manufacturing & Controls 
Lecture 87CMC Dossier & Compliance Management
Lecture 88Discussion on 85 common deficiency in CTD submission dossier
Section 9EU regulation
Lecture 89Introduction to EU Regulation 
Lecture 90Orientation to European Countries and National Regulatory Bodies
Lecture 91EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 92Overview of EU Regulation 
Lecture 93EMA and EMA Authorisation Process
Lecture 94Compassionate Use
Lecture 95EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 96EU Orphan Medicinal Products Regulation
Lecture 97Validity 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 98Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 99EU Orphan Medicinal Products Regulation
Lecture 100Conditional marketing authorisation
Lecture 101Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 102Summary of Product Characteristics 
Lecture 103Compassionate Use
Lecture 104MHRA - UK Regulation 
Lecture 105The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 106Accelerated assessment by EMEA
Lecture 107Master Data Maintenance by EMEA
Lecture 108EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 109EU Adaptive Pathway
Lecture 110European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 111SPOR  - Concept of Master Data Management  
Section 10Biopharmaceutical [Biotech & Biosimilar Regulation]
Lecture 112Introduction : Biopharmaceuticals
Lecture 113Classification of Biopharmaceutical 
Lecture 114Introduction to Biosimilar
Lecture 115Chemical Drugs Vs. Biologic Drugs
Lecture 116Principle of Naming of Biologics
Lecture 117Current Trends in Biopharmaceutical Market
Lecture 118Present Encouraging Factors for Biopharmaceutical Industry
Lecture 119Complexity of biopharma supply chain and operations
Lecture 120Biopharma Market Segmentation
Lecture 121Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 122Recombinant protein
Lecture 123Monoclonal Antibodies
Lecture 124Synthetic Immunomodulators
Lecture 125Production of Monoclonal Antibodies
Lecture 126Cytokines
Lecture 127Interferon
Lecture 128Erythropoiesis-stimulating agent
Lecture 129Biological Licensing Application (BLA) 
Lecture 130Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 131Vaccine development and approval Process
Lecture 132Purple Book: Significance | Searching | Assignments
Lecture 133Biosimilar Development Process
Lecture 134Strategic Consideration for Biosimilar Development 
Lecture 135Bio-Manufacturing Process
Lecture 136Studies required for approval of biosimilar
Section 11Medical Device Regulation
Lecture 137Medical Device Regulation - Introduction
Lecture 138Definition of Medical Device
Lecture 139Classification of Medical Devices
Lecture 140510k - Pre-market Notification
Lecture 141Premarket notification (510(k)) submission
Lecture 142Premarket notification (510(k)) submission
Lecture 143FDA decision making process for different classes of 510k applications
Lecture 144Premarket approval (PMA) application
Lecture 145Differences between 510k VS. PMA
Lecture 146PMA - Important Discussion
Lecture 147PMA - Quality System
Lecture 148PMA Labelling
Lecture 149Investigational Device Exemption
Lecture 150PMA Postapproval Requirements
Lecture 151Postmarket Surveillance Studies
Lecture 152PMA Supplements and Amendments
Lecture 153Expedited review of devices
Lecture 154Expiration Dating
Lecture 155Device Master Files
Lecture 156Unapproved use of Medical Devices 
Lecture 157Marketing, Advertising and Promotion of Medical Devices
Lecture 158FDA 513(g) Submission
Lecture 159De Novo Petition 
Lecture 160Humanitarian Device Exemption (HDE)
Lecture 161Combination Products
Lecture 162Premarket Review and Postmarket Regulation of Combination Products
Lecture 163Medical Devices Regulation in Canada
Lecture 164EU regulation on medical devices
Lecture 165Quality Management System (QMS) for medical devices
Lecture 166c-GMP Requirement for Medical Devices
Lecture 167Medical Devices Regulation in India
Lecture 168CE Marking : Practical Understanding - Requirements and Process
Lecture 169Techinical Dossier for Medical Devices
Lecture 170ISO 13485:2016 - Process Guidance
Lecture 171Medical Devices Recall - Classification and Procedure
Section 12USFDA Warning Letter and Data Integrity and Related Topics
Lecture 172Data Integrity issues in Pharmaceutical Industry
Lecture 173Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 174CAPA
Lecture 175Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity