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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 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 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
Section 2Clinical Trial / Research - Fundamental
Lecture 19Clinical Trials Terminologies
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 3IPR Related Topics (Optional)
Lecture 25USPTO - Introduction
Lecture 26Patent - Fundamental Concepts
Lecture 27Patent Application Process - USPTO
Lecture 28Trademark Search and Registration in US
Lecture 29Steps Know How & Key Points - Patent Application
Lecture 30IPR - Patent Grant and Handling Process in India (Optional)
Lecture 31Patent - Practical on search and filing in Indian Patent Office (Optional)
Lecture 32Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 33Trademark Search assignment (India) - (Optional)
Lecture 34Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 35Regulatory Strategies
Lecture 36Advance study on Para IV Filing
Lecture 37Para IV Notices
Lecture 38Evergreening - Patent Life Extension Strategies
Lecture 39Pay For Delay Strategy
Lecture 40REMS Strategic Planning 
Lecture 41Compulsory Licensing
Lecture 42Technology Licensing
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
Section 5GMP
Lecture 47Definition of GMP
Lecture 48Certification Pharmaceutical Companies / Plants
Lecture 49Introduction to Good Manufacturing Practices
Lecture 50G1 Lecture Premises & Plant Layout Designing
Lecture 51G2 Lecture Sanitation and Hygiene
Lecture 52G3 Lecture Equipment Modules
Lecture 53G4 Lecture Production Modules
Lecture 54G5 Lecture Documentation
Lecture 55G6 Lecture Quality Control
Lecture 56G7 Lecture Product Complaint
Lecture 57G8 Lecture Storage Module
Lecture 58ISO and ISO Audits
Lecture 59Pharmaceutical SOPs
Lecture 60SOP Automation in Pharmaceutical Industry
Section 6DMF & SMF
Lecture 61Key Consideration for Drug Master File Preparation and Submission 
Lecture 62Practical Understanding on Drug Master File Preparation and Submission
Lecture 63Practical Training on preparing DMF and SMF
Lecture 64DMF Completeness Assessment
Lecture 65Drug Master File - Fees
Lecture 66Drug Master File - Global Perspective [Across Different Regions]
Section 7Biosimilar
Lecture 67Biosimilar
Lecture 68Biosimilar Approval process
Lecture 69Biological Licensing Application (BLA)
Lecture 70Vaccine development and approval Process
Section 8USFDA warning Letter & CAPA
Lecture 71CAPA - Introduction
Lecture 72USFDA Warning Letter
Lecture 73Handling of warning letter
Lecture 74Case Study: Warning Letter
Section 9Drug Registration in European Country (Optional)
Lecture 75Introduction to EU Regulation
Lecture 76Orientation to European Countries and National Regulatory Bodies
Lecture 77Overview of EU Regulation
Lecture 78EMEA Procedures
Lecture 79Summary of Product Characteristics
Lecture 80Compassionate Use
Lecture 81MHRA - UK Regulation
Lecture 82EU Orphan Medicinal Products Regulation
Section 10GCC Drug Regulatory Affairs
Lecture 83Regions in Pharma Business : Common Terminologies
Lecture 84GCC Pharma Market
Lecture 85GCC Export
Lecture 86GCC Registration Procedure
Lecture 87Drug Registration in Saudi Arabia
Lecture 88Documentation Required for the GCC countries
Lecture 89Drug Registration in GCC countries
Lecture 90Medical Device Regulation in GCC countries
Section 11Drug Registration Dossier
Lecture 91Introduction to Common Technical Document (CTD)
Lecture 92Asean Common Technical Document (ACTD)
Lecture 93Introduction to Electronic Common Technical Document (ECTD)
Lecture 94Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 95Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 96Chemistry, Manufacturing & Controls - Fundamental Understanding 
Lecture 97CMC Dossier & Compliance Management
Lecture 98Black Box Warning
Lecture 99Importance of effective dossier management
Lecture 100Deficiencies observed in CTD Dossiers
Lecture 101Certificate of Analysis
Lecture 102Detailed Understanding on ANDA Submission Dossier 
Lecture 103Prior Approval Submission 
Lecture 104Detailed Understanding on ANDA Fees
Lecture 105Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 106NCE Vs. 505b2 application - Case Based Learning 
Lecture 107FTF - 180 Days Exclusivity - Case Based Learning
Lecture 108Classic case study of the 505b2 filing : Case Based Learning
Lecture 109Discussion on 85 common deficiency in CTD submission dossier
Lecture 110Data Integrity issues in Pharmaceutical Industry
Section 12ASEAN Drug Regulatory Affairs
Lecture 111Introduction
Lecture 112Asean Geography
Lecture 113Drug Registration in Brunei
Lecture 114Drug Registration in Malaysia
Lecture 115Drug Registration in Cambodia
Lecture 116Drug Registration in Mayanmar
Lecture 117Drug Registration in Philippines
Lecture 118Drug Registration in Singapore
Section 13Drug Regulation in India - CDSCO
Lecture 119Drug Regulation in India - CDSCO
Lecture 120National Pharmaceutical Pricing Authority
Lecture 121Drug Price Regulation in India
Lecture 122Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 123Drug Price Control Order 2013
Lecture 124Case Study of New Drug Approval in India
Section 14Introduction: Pharma Product Management
Lecture 125Career in Pharma Product Management
Lecture 126Detailed Understanding of Product Management Job
Section 15Fundamentals of Pharma Marketing
Lecture 127Marketing Orientation for Product Manager
Lecture 128Why Is Market Research Important in Pharmaceutical Business?
Lecture 129Product Life cycle - Basic Understanding
Lecture 130Concept of STP
Lecture 131Pricing
Lecture 132Distribution Channel in Pharmaceutical Industry 
Lecture 133Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 134A Pharmaceutical Segmentation outlook
Lecture 135Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 136Method of Promotional Budgeting
Lecture 137Basics of Advertising : Introduction
Lecture 138The Advertising agency Selection Process with Case Based Learning on Creative Brief Preparation
Lecture 139Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 140Advertising Planning - ATL, BTL, TTL activities
Section 16Practical Training on Pharma Brand Logo Development
Lecture 141Brand Logo - Introduction
Lecture 142Purpose of Brand Logo
Lecture 143Component of Brand Logo
Lecture 144Brand Name and TM Registration Process
Lecture 145Trademark - Practical on TM Search
Lecture 146Trademark Search assignment
Lecture 147Trademark Registration in US
Lecture 148How to design excellent brand logo?
Lecture 149Color Systems - RGB & CMYK
Lecture 150Few Case Studies related to brand names and logos
Lecture 151Brand Logo - Simulation
Lecture 152Colour Trademarking in Pharma Branding
Lecture 153How to protect pharma brands globally?
Lecture 154Rebranding Exercise in Pharmaceutical Industry
Lecture 155Brand Logo Development: Real Life Simulation
Section 17Marketing Plan / Brand Plan Fundamentals
Lecture 156 Basic Understanding how to launch a pharmaceutical product into the market
Lecture 157Marketing Campaign Development
Lecture 158How to prepare a Pharma Brand Plan
Lecture 159Marketing Plan : Sample Plan - Glimiperide + Metformin
Lecture 160Decide about brand USP -What to promote
Lecture 161How to prepare promotogram. Download sample Promotogram
Lecture 162Importance and Handling of Cycle Meeting and its importance
Lecture 163Sample Marketing Plan : Febuxostat
Lecture 164Sample Marketing Plan : Pregabalin
Lecture 165Sample Marketing Plan : Pregabalin
Lecture 166New Product Launch Case Study
Lecture 167Aristada - Launch Case Study
Lecture 168CSR Campaign
Lecture 169Sample Allocation Planning
Section 18Practical Training on Visual Aid Development
Lecture 170Importance of Visual Aid in Pharma Industry
Lecture 171Fundamentals of preparing visual aid
Lecture 172Indications for Drugs: Approved vs. Non-approved
Lecture 173Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 174Step by step visual aid development process
Lecture 175Guideline of Visual Aid Designing
Lecture 176Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 177Visual Aid Printing
Lecture 178Detailing and e-detailing
Lecture 179Visual Aid Development
Lecture 180Visual Aid, Literature reference Sample
Lecture 181Tablet vs. Conventional Detailing
Section 19Practical Training on Packaging Development
Lecture 182Artwork Development Process in PMT Department
Lecture 183Product List and Reminder card development
Lecture 184Catch Cover Development
Lecture 185Packaging Development
Lecture 186Prescribing Information and Patient Information Leaflet development
Lecture 187Pharma Packaging Case Studies
Section 20Analytics
Lecture 188Moving annual total (MAT)
Lecture 189Compound Annual Growth Rate (CAGR)
Lecture 190Analytical Approach in Determining Brand Potential with case study
Section 21Strategic Sessions
Lecture 191Co-promotion & Co-marketing strategy
Lecture 192Concept of Reverse co-promotion in pharma industry
Lecture 193In-Licensing Vs. Outlicensing
Lecture 194Importance of Publications in Pharmaceutical Industry
Lecture 195Juxtapid Case Study
Lecture 196New Indication Approval Process and Promotion
Section 22Basic Finance for Pharma managers
Section 23Case Study Directory
Section 24Marketing Strategy Related Sessions
Lecture 199Increase the brand reach with advance segmentation
Lecture 200Concept of uniform branding for better brand acceptability
Lecture 201Brand Line Extension : Importance and Strategic Planning 
Lecture 202Disease Awareness Campaign - Brand Building Activities on Specific Health Day
Lecture 203Medical Animation for Brand Building 
Lecture 204Celebrity Endorsement in Pharmaceutical Brand Promotion
Lecture 205Celebrity Endorsement Vs. Bootlegging 
Lecture 206Promotion Advertisement Regulations
Lecture 207Importance of Sponsoring Medical Conference: Promotion of Pharmaceutical Brands in Medical Conferences
Lecture 208Conference Banner Designing
Lecture 209Roll Up Standee