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Course Code: KPE-C-023N

Course Title: KPE’s Advance Diploma in Pharmaceutical Product Management and Regulatory Affairs (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 pharmaceutical Product Management and Regulatory Affairs can pursue the course.

Features of the Course:

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

2. Understanding/ Decision Making/ Strategy Creation in the field of Pharma Brand Management, Pharma Marketing, international marketing and regulatory affairs.

3. Pharma Marketing & Regulatory Affairs 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

Certificates: Two separate certificate (for drug regulatory affairs and pharmaceutical product management) will be provided.

Course Flow : Course covers comprehensively total regulatory affairs syllabus and pharma product management syllabus.

Section 1Fundamental of Drug Discovery, Development (US Regulation)
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Complete Response Letter | Key understanding | Management and Action Plan
Lecture 7Generic Drug User Fees Act (GDUFA)
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Handling of orange book
Lecture 10USFDA Expedited Programs (Detailed Understanding)
Lecture 11Practical Training on INDA, NDA, ANDA filing
Lecture 12505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivity
Lecture 16Learning from New Drug Approvals
Lecture 17Orphan Drug & Orphan Drug Act
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 2Clinical Trial / Research - Fundamental
Lecture 21Clinical Trials Terminologies
Lecture 22Clinical Trial Protocol Writing
Lecture 23Ethics in Clinical Research
Lecture 24Informed Consent
Lecture 25FDA Forms and How to fill the resources
Lecture 26Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3IPR Related Topics (Optional)
Lecture 27USPTO - Introduction
Lecture 28Patent - Fundamental Concepts
Lecture 29Patent Application Process - USPTO
Lecture 30Trademark Search and Registration in US
Lecture 31Steps Know How & Key Points - Patent Application
Lecture 32IPR - Patent Grant and Handling Process in India (Optional)
Lecture 33Patent - Practical on search and filing in Indian Patent Office (Optional)
Lecture 34Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 35Trademark Search assignment (India) - (Optional)
Lecture 36Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 37Regulatory Strategies
Lecture 38Advance study on Para IV Filing
Lecture 39Para IV Notices
Lecture 40Evergreening - Patent Life Extension Strategies
Lecture 41Pay For Delay Strategy
Lecture 42REMS Strategic Planning 
Lecture 43Compulsory Licensing
Lecture 44Technology Licensing
Lecture 45In-Licensing Vs. Outlicensing
Lecture 46LOE Strategies for Innovator Brands with case study
Lecture 47Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 48Drug Repurposing
Section 5GMP
Lecture 49Definition of GMP
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
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 65Practical Training on preparing DMF and SMF
Lecture 66DMF Completeness Assessment
Lecture 67Drug Master File - Fees
Lecture 68Drug Master File - Global Perspective [Across Different Regions]
Section 7Biosimilar
Lecture 69Classification of Biopharmaceutical 
Lecture 70Introduction to Biosimilar 
Lecture 71Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 72Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 73Purple Book: Significance | Searching | Assignments
Lecture 74Vaccine development and approval Process
Lecture 75Biosimilar Development Process
Lecture 76Strategic Consideration for Biosimilar Development 
Lecture 77Bio-Manufacturing Process Information
Lecture 78Studies required for approval of biosimilar
Section 8USFDA warning Letter & CAPA
Lecture 79Data Integrity issues in Pharmaceutical Industry
Lecture 80Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 81Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 9Drug Registration in European Country (Optional)
Lecture 82Introduction to EU Regulation
Lecture 83Orientation to European Countries and National Regulatory Bodies
Lecture 84Overview of EU Regulation
Lecture 85EMEA Procedures
Lecture 86Summary of Product Characteristics
Lecture 87Compassionate Use
Lecture 88MHRA - UK Regulation
Lecture 89EU Orphan Medicinal Products Regulation
Section 10GCC Drug Regulatory Affairs
Lecture 90Regions in Pharma Business : Common Terminologies
Lecture 91GCC Pharma Market
Lecture 92GCC Export
Lecture 93GCC Registration Procedure
Lecture 94Documentation Required for the GCC countries
Lecture 95Drug Registration in Saudi Arabia
Lecture 96Drug Registration in UAE
Lecture 97Drug Registration in Kuwait
Lecture 98Drug Registration in Bahrain
Lecture 99Drug Registration in Oman
Section 11Drug Registration Dossier
Lecture 100Introduction to Common Technical Document (CTD)
Lecture 101Asean Common Technical Document (ACTD)
Lecture 102Introduction to Electronic Common Technical Document (ECTD)
Lecture 103Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 104Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 105Chemistry, Manufacturing & Controls - Fundamental Understanding 
Lecture 106CMC Dossier & Compliance Management
Lecture 107Black Box Warning
Lecture 108Importance of effective dossier management
Lecture 109Deficiencies observed in CTD Dossiers
Lecture 110Certificate of Analysis
Lecture 111Detailed Understanding on ANDA Submission Dossier 
Lecture 112Prior Approval Submission 
Lecture 113Detailed Understanding on ANDA Fees
Lecture 114Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 115NCE Vs. 505b2 application - Case Based Learning 
Lecture 116FTF - 180 Days Exclusivity - Case Based Learning
Lecture 117Classic case study of the 505b2 filing : Case Based Learning
Lecture 118Discussion on 85 common deficiency in CTD submission dossier
Lecture 119Data Integrity issues in Pharmaceutical Industry
Section 12ASEAN Drug Regulatory Affairs
Lecture 120Introduction
Lecture 121Asean Geography
Lecture 122Drug Registration in Brunei
Lecture 123Drug Registration in Malaysia
Lecture 124Drug Registration in Cambodia
Lecture 125Drug Registration in Mayanmar
Lecture 126Drug Registration in Philippines
Lecture 127Drug Registration in Singapore
Section 13Introduction: Pharma Product Management
Lecture 128Career in Pharma Product Management
Lecture 129Detailed Understanding of Product Management Job
Section 14Fundamentals of Pharma Marketing
Lecture 130Marketing Orientation for Product Manager
Lecture 131Why Is Market Research Important in Pharmaceutical Business?
Lecture 132Product Life cycle - Basic Understanding
Lecture 133Concept of STP
Lecture 134Pricing
Lecture 135Distribution Channel in Pharmaceutical Industry 
Lecture 136Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 137A Pharmaceutical Segmentation outlook
Lecture 138Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 139Method of Promotional Budgeting
Lecture 140Basics of Advertising : Introduction
Lecture 141The Advertising agency Selection Process with Case Based Learning on Creative Brief Preparation
Lecture 142Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 143Advertising Planning - ATL, BTL, TTL activities
Lecture 144Target Audiences for Pharma Promotion : Types and Specialization
Lecture 145Business segments of Pharmaceutical Companies
Lecture 146Target Audience Selection Based on Products
Section 15Practical Training on Pharma Brand Logo Development
Lecture 147Brand Logo - Introduction
Lecture 148Purpose of Brand Logo
Lecture 149Component of Brand Logo
Lecture 150Brand Name and TM Registration Process
Lecture 151Trademark - Practical on TM Search
Lecture 152Trademark Search assignment
Lecture 153Trademark Registration in US
Lecture 154How to design excellent brand logo?
Lecture 155Color Systems - RGB & CMYK
Lecture 156Few Case Studies related to brand names and logos
Lecture 157Brand Logo - Simulation
Lecture 158Colour Trademarking in Pharma Branding
Lecture 159How to protect pharma brands globally?
Lecture 160Rebranding Exercise in Pharmaceutical Industry
Lecture 161Brand Logo Development: Real Life Simulation
Section 16Marketing Plan / Brand Plan Fundamentals
Lecture 162 Basic Understanding how to launch a pharmaceutical product into the market
Lecture 163Marketing Campaign Development
Lecture 164How to prepare a Practical Training on Marketing Plan Preparation with real life example
Lecture 165Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting 
Lecture 166Decide about brand USP -What to promote
Lecture 167How to prepare promotogram. Download sample Promotogram
Lecture 168Importance and Handling of Cycle Meeting and its importance
Lecture 169Sample Marketing Plan : Febuxostat
Lecture 170Sample Marketing Plan : Pregabalin
Lecture 171Sample Marketing Plan : Pregabalin
Lecture 172New Product Launch Case Study
Lecture 173Aristada - Launch Case Study
Lecture 174CSR Campaign
Lecture 175Sample Allocation Planning
Section 17Practical Training on Visual Aid Development
Lecture 176Importance of Visual Aid in Pharma Industry
Lecture 177Fundamentals of preparing visual aid
Lecture 178Indications for Drugs: Approved vs. Non-approved
Lecture 179Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 180Step by step visual aid development process
Lecture 181Guideline of Visual Aid Designing
Lecture 182Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 183Visual Aid Printing
Lecture 184Detailing and e-detailing
Lecture 185Visual Aid Development
Lecture 186Visual Aid, Literature reference Sample
Lecture 187Tablet vs. Conventional Detailing
Section 18Practical Training on Packaging Development
Lecture 188Artwork Development Process in PMT Department
Lecture 189Product List and Reminder card development
Lecture 190Catch Cover Development
Lecture 191Packaging Development
Lecture 192Prescribing Information and Patient Information Leaflet development
Lecture 193Pharma Packaging Case Studies
Section 19Analytics
Lecture 194Moving annual total (MAT)
Lecture 195Compound Annual Growth Rate (CAGR)
Lecture 196Analytical Approach in Determining Brand Potential with case study
Section 20Strategic Sessions
Lecture 197Co-promotion & Co-marketing strategy
Lecture 198Concept of Reverse co-promotion in pharma industry
Lecture 199In-Licensing Vs. Outlicensing
Lecture 200Importance of Publications in Pharmaceutical Industry
Lecture 201Juxtapid Case Study
Lecture 202New Indication Approval Process and Promotion
Section 21Basic Finance for Pharma managers
Section 22Case Study Directory
Section 23Marketing Strategy Related Sessions
Lecture 205Increase the brand reach with advance segmentation
Lecture 206Concept of uniform branding for better brand acceptability
Lecture 207Brand Line Extension : Importance and Strategic Planning 
Lecture 208Disease Awareness Campaign - Brand Building Activities on Specific Health Day
Lecture 209Medical Animation for Brand Building 
Lecture 210Celebrity Endorsement in Pharmaceutical Brand Promotion
Lecture 211Celebrity Endorsement Vs. Bootlegging 
Lecture 212Promotion Advertisement Regulations
Lecture 213Importance of Sponsoring Medical Conference: Promotion of Pharmaceutical Brands in Medical Conferences
Lecture 214Conference Banner Designing
Lecture 215Roll Up Standee