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Admission Process

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Course Application Form

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 10Priority Accelerated Review
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
Section 2Clinical Trial / Research - Fundamental
Lecture 18Clinical Trials Terminologies
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent
Section 3IPR Related Topics (Optional)
Lecture 22USPTO - Introduction
Lecture 23Patent - Fundamental Concepts
Lecture 24Patent Application Process - USPTO
Lecture 25Trademark Search and Registration in US
Lecture 26Steps Know How & Key Points - Patent Application
Lecture 27IPR - Patent Grant and Handling Process in India (Optional)
Lecture 28Patent - Practical on search and filing in Indian Patent Office (Optional)
Lecture 29Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 30Trademark Search assignment (India) - (Optional)
Lecture 31Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 32Regulatory Strategies
Lecture 33Advance study on Para IV Filing
Lecture 34Evergreening - Patent Life Extension Strategies
Lecture 35Drug Repurposing
Lecture 36Pay For Delay Strategy
Lecture 37Pediatric Exclusivity - Case Study
Lecture 38Compulsory Licensing
Lecture 39Technology Licensing
Section 5GMP
Lecture 40Definition of GMP
Lecture 41Certification Pharmaceutical Companies / Plants
Lecture 42Introduction to Good Manufacturing Practices
Lecture 43G1 Lecture Premises & Plant Layout Designing
Lecture 44G2 Lecture Sanitation and Hygiene
Lecture 45G3 Lecture Equipment Modules
Lecture 46G4 Lecture Production Modules
Lecture 47G5 Lecture Documentation
Lecture 48G6 Lecture Quality Control
Lecture 49G7 Lecture Product Complaint
Lecture 50G8 Lecture Storage Module
Lecture 51ISO and ISO Audits
Lecture 52Pharmaceutical SOPs
Lecture 53SOP Automation in Pharmaceutical Industry
Section 6DMF & SMF
Lecture 54DMF & SMF
Lecture 55Site Master File
Lecture 56Practical Training on preparing DMF and SMF
Section 7Biosimilar
Lecture 57Biosimilar
Lecture 58Biosimilar Approval process
Lecture 59Biological Licensing Application (BLA)
Lecture 60Vaccine development and approval Process
Section 8USFDA warning Letter & CAPA
Lecture 61CAPA - Introduction
Lecture 62USFDA Warning Letter
Lecture 63Handling of warning letter
Lecture 64Case Study: Warning Letter
Section 9Drug Registration in European Country (Optional)
Lecture 65Introduction to EU Regulation
Lecture 66Orientation to European Countries and National Regulatory Bodies
Lecture 67Overview of EU Regulation
Lecture 68EMEA Procedures
Lecture 69Summary of Product Characteristics
Lecture 70Compassionate Use
Lecture 71MHRA - UK Regulation
Lecture 72EU Orphan Medicinal Products Regulation
Section 10GCC Drug Regulatory Affairs
Lecture 73Regions in Pharma Business : Common Terminologies
Lecture 74GCC Pharma Market
Lecture 75GCC Export
Lecture 76GCC Registration Procedure
Lecture 77Drug Registration in Saudi Arabia
Lecture 78Documentation Required for the GCC countries
Lecture 79Drug Registration in GCC countries
Lecture 80Medical Device Regulation in GCC countries
Section 11Drug Registration Dossier
Lecture 81Introduction to Common Technical Document (CTD)
Lecture 82Asean Common Technical Document (ACTD)
Lecture 83Introduction to Electronic Common Technical Document (ECTD)
Lecture 84Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 85Modules on Stability Study
Lecture 86Stability Study Test
Lecture 87Module on Interchangeability
Lecture 88Stability Testing of API
Lecture 89Stability Testing of Finished Pharmaceutical Products
Lecture 90Review Test on Stability Testing
Section 12ASEAN Drug Regulatory Affairs
Lecture 91Introduction
Lecture 92Asean Geography
Lecture 93Drug Registration in Brunei
Lecture 94Drug Registration in Malaysia
Lecture 95Drug Registration in Cambodia
Lecture 96Drug Registration in Mayanmar
Lecture 97Drug Registration in Philippines
Lecture 98Drug Registration in Singapore
Section 13Drug Regulation in India - CDSCO
Lecture 99Drug Regulation in India - CDSCO
Lecture 100National Pharmaceutical Pricing Authority
Lecture 101Drug Price Regulation in India
Lecture 102Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 103Drug Price Control Order 2013
Lecture 104Case Study of New Drug Approval in India
Section 14Introduction: Pharma Product Management
Lecture 105Career in Pharma Product Management
Lecture 106Detailed Understanding of Product Management Job
Section 15Fundamentals of Pharma Marketing
Lecture 107Marketing Orientation for Product Manager
Lecture 108Why Is Market Research Important in Pharmaceutical Business?
Lecture 109Consumer buying behavior
Lecture 110Product Life cycle - Basic Understanding
Lecture 111Concept of STP
Lecture 112Pricing
Lecture 113Distribution and Logistics
Lecture 114Segmentation, Targeting and Positioning
Lecture 115A Pharmaceutical Segmentation outlook
Lecture 116Market Research: Importance in Pharma Product Management
Lecture 117Distribution Channel in Pharmaceuticals
Lecture 118Promotion Management Process in a Pharmaceutical Company:
Lecture 119Setting and Quantifying Promotional Objectives
Lecture 120Promotional Budget Setting : Tools and Techniques
Lecture 121Basics of Advertising : Introduction
Lecture 122Classifications of Advertising
Lecture 123The Advertising agency
Section 16Practical Training on Pharma Brand Logo Development
Lecture 124Brand Logo - Introduction
Lecture 125Purpose of Brand Logo
Lecture 126Component of Brand Logo
Lecture 127Brand Name and TM Registration Process
Lecture 128Trademark - Practical on TM Search
Lecture 129Trademark Search assignment
Lecture 130Trademark Registration in US
Lecture 131How to design excellent brand logo?
Lecture 132Color Systems - RGB & CMYK
Lecture 133Few Case Studies related to brand names and logos
Lecture 134Brand Logo - Simulation
Lecture 135Colour Trademarking in Pharma Branding
Lecture 136How to protect pharma brands globally?
Lecture 137Rebranding Exercise in Pharmaceutical Industry
Lecture 138Brand Logo Development: Real Life Simulation
Section 17Marketing Plan / Brand Plan Fundamentals
Lecture 139 Basic Understanding how to launch a pharmaceutical product into the market
Lecture 140Marketing Campaign Development
Lecture 141How to prepare a Pharma Brand Plan
Lecture 142Marketing Plan : Sample Plan - Glimiperide + Metformin
Lecture 143Decide about brand USP -What to promote
Lecture 144How to prepare promotogram. Download sample Promotogram
Lecture 145Importance and Handling of Cycle Meeting and its importance
Lecture 146Sample Marketing Plan : Febuxostat
Lecture 147Sample Marketing Plan : Pregabalin
Lecture 148Sample Marketing Plan : Pregabalin
Lecture 149New Product Launch Case Study
Lecture 150Aristada - Launch Case Study
Lecture 151CSR Campaign
Lecture 152Sample Allocation Planning
Section 18Practical Training on Visual Aid Development
Lecture 153Importance of Visual Aid in Pharma Industry
Lecture 154Fundamentals of preparing visual aid
Lecture 155Indications for Drugs: Approved vs. Non-approved
Lecture 156Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 157Step by step visual aid development process
Lecture 158Guideline of Visual Aid Designing
Lecture 159Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 160Visual Aid Printing
Lecture 161Detailing and e-detailing
Lecture 162Visual Aid Development
Lecture 163Visual Aid, Literature reference Sample
Lecture 164Tablet vs. Conventional Detailing
Section 19Practical Training on Packaging Development
Lecture 165Artwork Development Process in PMT Department
Lecture 166Product List and Reminder card development
Lecture 167Catch Cover Development
Lecture 168Packaging Development
Lecture 169Prescribing Information and Patient Information Leaflet development
Lecture 170Pharma Packaging Case Studies
Section 20Analytics
Lecture 171Moving annual total (MAT)
Lecture 172Compound Annual Growth Rate (CAGR)
Lecture 173Analytical Approach in Determining Brand Potential with case study
Section 21Strategic Sessions
Lecture 174Co-promotion & Co-marketing strategy
Lecture 175Concept of Reverse co-promotion in pharma industry
Lecture 176In-Licensing Vs. Outlicensing
Lecture 177Importance of Publications in Pharmaceutical Industry
Lecture 178Juxtapid Case Study
Lecture 179New Indication Approval Process and Promotion
Section 22Basic Finance for Pharma managers
Section 23Case Study Directory
Section 24Conference Management Skills Development
Section 25Promotion Advertisement Regulations
Section 26Celebrity Endorsement in Pharmaceuticals