TypeOnline Course
Student Enrolled2
Price$790 / 38500 INR
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Admission Process

Admission Process

Upon receiving your filled up application form, our admin team will generate PROVISIONAL ADMISSION ID and send you the PROVISIONAL ADMISSION LETTER along with instruction to course fees payment options.

Course Application Form

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 7Review on Drug Discovery and Development 
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
Section 3Clinical Trial and Research
Lecture 19Clinical Trial Detailed Study (Topic - 1-11)
Lecture 20Clinical Trial Protocol Writing
Lecture 21Ethics in Clinical Research
Lecture 22Informed Consent 
Lecture 23FDA Forms and How to fill the resources
Lecture 24Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 4Intellectual Property Management
Lecture 25Functions of the United States Patent and Trademark Office
Lecture 26Patent
Lecture 27Application For Patent - USPTO 
Lecture 28Trademark Search and Registration in US
Lecture 29Steps Know How & Key Points - Patent Application 
Lecture 30IPR - Patent Grant and Handling Process
Lecture 31Patent - Practical on search and filing
Lecture 32Trademark - Practical on TM Search & Registration Process
Lecture 33Trademark Search assignment (optional)
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 59ISO and ISO Audits
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[gdlr_button href="https://www.nckpharma.com/dra/deficiencyinCTD/" target="_self" size="medium" background="#FF8000" color="#ffffff"]Start Course[/gdlr_button]Password: 31726
Section 9EU regulation
Lecture 88Introduction to EU Regulation 
Lecture 89Orientation to European Countries and National Regulatory Bodies
Lecture 90Overview of EU Regulation 
Lecture 91EMEA Procedures
Lecture 92Summary of Product Characteristics 
Lecture 93Compassionate Use
Lecture 94MHRA - UK Regulation 
Lecture 95EU Orphan Medicinal Products Regulation
Lecture 96The 'sunset clause' for marketing authorisations of pharmaceuticals
Section 10Biopharmaceutical [Biotech & Biosimilar Regulation]
Lecture 97Introduction : Biopharmaceuticals
Lecture 98Classification of Biopharmaceutical 
Lecture 99Introduction to Biosimilar
Lecture 100Chemical Drugs Vs. Biologic Drugs
Lecture 101Principle of Naming of Biologics
Lecture 102Current Trends in Biopharmaceutical Market
Lecture 103Present Encouraging Factors for Biopharmaceutical Industry
Lecture 104Complexity of biopharma supply chain and operations
Lecture 105Biopharma Market Segmentation
Lecture 106Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 107Recombinant protein
Lecture 108Monoclonal Antibodies
Lecture 109Synthetic Immunomodulators
Lecture 110Production of Monoclonal Antibodies
Lecture 111Cytokines
Lecture 112Interferon
Lecture 113Erythropoiesis-stimulating agent
Lecture 114Biological Licensing Application (BLA) 
Lecture 115Biosimilar Approval process
Lecture 116Vaccine development and approval Process
Lecture 117Review : 351(a) vs. 351(k) pathway
Lecture 118Biosimilar Development Process
Lecture 119Strategic Consideration for Biosimilar Development 
Lecture 120Bio-Manufacturing Process
Section 11Medical Device Regulation
Lecture 121Medical Device Regulation - Introduction
Lecture 122Definition of Medical Device
Lecture 123Classification of Medical Devices
Lecture 124510k - Pre-market Notification
Lecture 125Premarket notification (510(k)) submission
Lecture 126Premarket notification (510(k)) submission
Lecture 127FDA decision making process for different classes of 510k applications
Lecture 128Premarket approval (PMA) application
Lecture 129Differences between 510k VS. PMA
Lecture 130PMA - Important Discussion
Lecture 131PMA - Quality System
Lecture 132PMA Labelling
Lecture 133Investigational Device Exemption
Lecture 134PMA Postapproval Requirements
Lecture 135Postmarket Surveillance Studies
Lecture 136PMA Supplements and Amendments
Lecture 137Expedited review of devices
Lecture 138Expiration Dating
Lecture 139Device Master Files
Lecture 140Unapproved use of Medical Devices 
Lecture 141Marketing, Advertising and Promotion of Medical Devices
Lecture 142FDA 513(g) Submission
Lecture 143De Novo Petition 
Lecture 144Humanitarian Device Exemption (HDE)
Lecture 145Combination Products
Lecture 146Premarket Review and Postmarket Regulation of Combination Products
Lecture 147Medical Devices Regulation in Canada
Lecture 148EU regulation on medical devices
Lecture 149Quality Management System (QMS) for medical devices
Lecture 150c-GMP Requirement for Medical Devices
Lecture 151Medical Devices Regulation in India
Lecture 152CE Marking : Practical Understanding - Requirements and Process
Lecture 153Techinical Dossier for Medical Devices
Lecture 154ISO 13485:2016 - Process Guidance
Lecture 155Medical Devices Recall - Classification and Procedure
Section 12Data Integrity and Related Topics
Lecture 156Data Integrity issues in Pharmaceutical Industry
Lecture 157USFDA Warning Letter
Lecture 158CAPA