TypeOnline Course
Price$790 / Rs. 38500
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Admission Process

Admission Process

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Course Objective: This course will cover complete ADVANCE PG DIPLOMA IN DRUG REGULATORY AFFAIRS AND ADVANCE PG DIPLOMA IN PRODUCTION MANEGEMENT under single course. All content of regulatory affairs and production management course will be covered under this.

Course Code: KPE-C-021
Course: KPE’s Advance Diploma in Pharmaceutical Production Management and Drug Regulatory Affairs (Dual Specialization)
Course Duration: 1 Year
Nature of the Course: Distance & e-Learning

Course Fees: 
  • 790 USD [For payment other than India]
  • 38500 Indian Rupees [For payment from India]

Entire Pharmaceutical Production Management and Drug Regulatory Affairs Course will be covered in this dual specialization.

Course Duration: 1 Year

Who can apply the course: 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 pharmaceutical marketing can pursue the course.

Features of the Course:

1. Comprehensive study material covering all important aspects of Pharmaceutical Production and Regulatory Affairs.

2. Understanding/ Decision Making/ Strategy Creation in the field of Pharma Production and Regulatory Affairs

3. 143 Case Live Pharmaceutical Production and Regulatory Case studies.

4. Support : Resume Development, Placement Assistance.

Unique Features:

  • Comprehensive study material covering all aspects of drug regulatory affairs will be covered under this course.
  • Comprehensive study material covering all important aspects of Pharmaceutical Production
  • Orientation to job related practical aspects of Pharmaceutical Production and drug regulatory affairs
  • Access to industry data bank of Standard Operating Procedures (SOPs) for different equipment
  • Specialized modules covering all Pharmaceutical Dosage Forms
  • Specialized modules on GMP, ISO guidelines as well as handling of GMP and ISO audits
  • Special module on Production related regulatory affairs
  • Support : Resume Development
Section 1Fundamental of Drug Discovery, Development (US Regulation)
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Review on Drug Discovery and Development
Lecture 7Generic Drug User Fees Act (GDUFA)
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Handling of orange book
Lecture 10Expedited drug approvals
Lecture 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Authorized Generics: Key Understanding
Lecture 13Exploratory IND Vs. Traditional IND
Lecture 14Patents Vs. exclusivity
Lecture 15Orphan Drug Designation 
Lecture 16Advance Learning on 505B2 Pathway
Lecture 17Chemistry, Manufacturing & Controls 
Section 2Fundamental of Clinical Trials
Lecture 18Clinical Trials Terminologies
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent
Lecture 22FDA Forms and How to fill the resources
Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 24Clinical Trial Failure: Lack of Efficacy - Case Study
Lecture 25Clinical Trial Failure: Lack of Efficacy - Case Study
Section 3IPR related topics
Lecture 26Functions of the United States Patent and Trademark Office
Lecture 27Patent
Lecture 28Patent - Practical on search and filing
Lecture 29Trademark - Practical on TM Search & Registration Process
Lecture 30Trademark - Practical on TM Search
Lecture 31Trademark Search assignment
Lecture 32Patent - Practical on search and filing in Indian Patent Office (Optional)
Lecture 33Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 34Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 35Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 36Regulatory Strategies in different phases of Clinical Trial
Lecture 37Advance study on Para IV Filing
Lecture 38Para IV Notices
Lecture 39Evergreening - Patent Life Extension Strategies
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 48Practical Queries on different USFDA application and Filing 
Section 5Good Manufacturing Practices
Lecture 49GMP
Lecture 50Certification Pharmaceutical Companies / Plants
Lecture 51Introduction to Good Manufacturing Practices
Lecture 52G1 Lecture Premises & Plant Layout Designing
Lecture 53G2 Lecture Sanitation and Hygiene
Lecture 54G3 Lecture Equipment Modules
Lecture 55G4 Lecture Production Modules
Lecture 56G5 Lecture Documentation
Lecture 57G6 Lecture Quality Control
Lecture 58G7 Lecture Product Complaint
Lecture 59G8 Lecture Storage Module
Lecture 60ISO and ISO Audits
Lecture 61Pharmaceutical SOPs Management from regulatory perspective
Lecture 62SOP Automation in Pharmaceutical Industry
Section 6DMF & SMF
Lecture 63Key Consideration for Drug Master File Preparation and Submission 
Lecture 64Practical Understanding on Drug Master File Preparation and Submission
Lecture 65Associated Learning: Site Master File - Detailed Understanding 
Lecture 66DMF Completeness Assessment
Lecture 67Drug Master File - Fees
Lecture 68Drug Master File - Global Perspective [Across Different Regions]
Section 7Biosimilar Regulatory Affairs
Lecture 69Introduction : Biopharmaceuticals
Lecture 70Classification of Biopharmaceutical 
Lecture 71Introduction to Biosimilar 
Lecture 72Chemical Drugs Vs. Biologic Drugs
Lecture 73Principle of Naming of Biologics
Lecture 74Current Trends in Biopharmaceutical Market
Lecture 75Present Encouraging Factors for Biopharmaceutical Industry
Lecture 76Complexity of biopharma supply chain and operations
Lecture 77Global Biologics Market - Classes and market share
Lecture 78Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 79Recombinant protein
Lecture 80Monoclonal Antibodies
Lecture 81Synthetic Immunomodulators
Lecture 82Production of Monoclonal Antibodies
Lecture 83Cytokines
Lecture 84Interferon
Lecture 85Erythropoiesis-stimulating agent
Lecture 86Biological Licensing Application (BLA) 
Lecture 87Biosimilar Approval process
Lecture 88Vaccine development and approval Process
Lecture 89Review : 351(a) vs. 351(k) pathway
Lecture 90Biosimilar Development Process
Lecture 91Strategic Consideration for Biosimilar Development 
Lecture 92Bio-Manufacturing Process Information
Section 8USFDA warning Letter & CAPA
Lecture 93Data Integrity issues in Pharmaceutical Industry
Lecture 94USFDA Warning Letter
Lecture 95Handling of warning letter
Lecture 96Case Study: Warning Letter for The Halol plant of Sun Pharma
Lecture 97CAPA
Section 9EU Regulatory Affairs
Lecture 98Introduction to EU Regulation
Lecture 99Orientation to European Countries and National Regulatory Bodies
Lecture 100Overview of EU Regulation
Lecture 101EMEA Procedures
Lecture 102Summary of Product Characteristics
Lecture 103Compassionate Use
Lecture 104MHRA - UK Regulation
Lecture 105EU Orphan Medicinal Products Regulation
Section 10Drug Dossier
Lecture 106Introduction to Common Technical Document (CTD)
Lecture 107CMC Dossier & Compliance Management
Lecture 108Introduction to Electronic Common Technical Document (ECTD)
Lecture 109Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 110Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 111Review Test on Stability Testing 
Lecture 112Black Box Warning
Lecture 113Importance of effective dossier management
Lecture 114Deficiencies observed in CTD Dossiers:
Lecture 115Certificate of Analysis
Lecture 116Detailed Understanding on ANDA Submission Dossier 
Lecture 117Prior Approval Submission 
Lecture 118Detailed Understanding on ANDA Fees
Lecture 119Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 120NCE Vs. 505b2 application - Case Based Learning 
Lecture 121FTF - 180 Days Exclusivity - Case Based Learning
Lecture 122Classic case study of the 505b2 filing : Case Based Learning
Lecture 123Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 124Asean Common Technical Document (ACTD) 
Lecture 125Discussionon 85 common deficiency in CTD submission dossier
Section 11Portfolio Management - Strategic Point of View
Lecture 126Advance understanding of the portfolio Management
Lecture 127Importance of market research in pharmaceutical industry
Lecture 128Co-promotion & Co-marketing strategy in pharma industry
Lecture 129Concept of Reverse co-promotion in pharma industry
Lecture 130In-Licensing Vs. Outlicensing
Lecture 131Publication Management from Regulatory perspective
Lecture 132Juxtapid Case Study
Lecture 133New Indication Approval Process and Promotion
Lecture 134OTC Switch
Lecture 135Practical Case Study in Rx to OTC Switch
Section 12API Regulatory Affairs
Section 1348 different topics of the Regulatory Affairs, Case Studies and Self Assessment Tests
Section 14Basic Fundamentals of Pharmaceutical Production Management
Lecture 138P1 Introduction to Production Management
Lecture 139P2 TYPES OF PRODUCTION & Classification
Lecture 140P3 Productivity Concept of measuring success
Lecture 141P4 Factors affecting productivity
Lecture 142P5 Industrial efficiency
Lecture 143P6 Concept of Efficiency, Effectiveness and Productivity
Lecture 144P7 Production Management Review Test
Lecture 145P8 Introduction to ERGONOMICS
Lecture 146P9 Concept of work designing
Lecture 147P10 Production Planning - Objective and Importance
Lecture 148P11 Production Planning Steps and Control
Lecture 149P12 Control Chart
Lecture 150P13 Quality Control
Lecture 152P15 Plant Layout
Lecture 153P16 Material Management - Introduction
Lecture 154P17 Inventory Management
Section 15Production Management - Pharmaceutical Dosage Forms and Manufacturing Process
Section 16Final Examination