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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 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
Lecture 96Stability Study Test
Lecture 97Module on Interchangeability
Lecture 98Stability Testing of API
Lecture 99Stability Testing of Finished Pharmaceutical Products
Lecture 100Review Test on Stability Testing
Section 12ASEAN Drug Regulatory Affairs
Lecture 101Introduction
Lecture 102Asean Geography
Lecture 103Drug Registration in Brunei
Lecture 104Drug Registration in Malaysia
Lecture 105Drug Registration in Cambodia
Lecture 106Drug Registration in Mayanmar
Lecture 107Drug Registration in Philippines
Lecture 108Drug Registration in Singapore
Section 13Drug Regulation in India - CDSCO
Lecture 109Drug Regulation in India - CDSCO
Lecture 110National Pharmaceutical Pricing Authority
Lecture 111Drug Price Regulation in India
Lecture 112Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 113Drug Price Control Order 2013
Lecture 114Case Study of New Drug Approval in India
Section 14Introduction: Pharma Product Management
Lecture 115Career in Pharma Product Management
Lecture 116Detailed Understanding of Product Management Job
Section 15Fundamentals of Pharma Marketing
Lecture 117Marketing Orientation for Product Manager
Lecture 118Why Is Market Research Important in Pharmaceutical Business?
Lecture 119Consumer buying behavior
Lecture 120Product Life cycle - Basic Understanding
Lecture 121Concept of STP
Lecture 122Pricing
Lecture 123Distribution and Logistics
Lecture 124Segmentation, Targeting and Positioning
Lecture 125A Pharmaceutical Segmentation outlook
Lecture 126Market Research: Importance in Pharma Product Management
Lecture 127Distribution Channel in Pharmaceuticals
Lecture 128Promotion Management Process in a Pharmaceutical Company:
Lecture 129Setting and Quantifying Promotional Objectives
Lecture 130Promotional Budget Setting : Tools and Techniques
Lecture 131Basics of Advertising : Introduction
Lecture 132Classifications of Advertising
Lecture 133The Advertising agency
Section 16Practical Training on Pharma Brand Logo Development
Lecture 134Brand Logo - Introduction
Lecture 135Purpose of Brand Logo
Lecture 136Component of Brand Logo
Lecture 137Brand Name and TM Registration Process
Lecture 138Trademark - Practical on TM Search
Lecture 139Trademark Search assignment
Lecture 140Trademark Registration in US
Lecture 141How to design excellent brand logo?
Lecture 142Color Systems - RGB & CMYK
Lecture 143Few Case Studies related to brand names and logos
Lecture 144Brand Logo - Simulation
Lecture 145Colour Trademarking in Pharma Branding
Lecture 146How to protect pharma brands globally?
Lecture 147Rebranding Exercise in Pharmaceutical Industry
Lecture 148Brand Logo Development: Real Life Simulation
Section 17Marketing Plan / Brand Plan Fundamentals
Lecture 149 Basic Understanding how to launch a pharmaceutical product into the market
Lecture 150Marketing Campaign Development
Lecture 151How to prepare a Pharma Brand Plan
Lecture 152Marketing Plan : Sample Plan - Glimiperide + Metformin
Lecture 153Decide about brand USP -What to promote
Lecture 154How to prepare promotogram. Download sample Promotogram
Lecture 155Importance and Handling of Cycle Meeting and its importance
Lecture 156Sample Marketing Plan : Febuxostat
Lecture 157Sample Marketing Plan : Pregabalin
Lecture 158Sample Marketing Plan : Pregabalin
Lecture 159New Product Launch Case Study
Lecture 160Aristada - Launch Case Study
Lecture 161CSR Campaign
Lecture 162Sample Allocation Planning
Section 18Practical Training on Visual Aid Development
Lecture 163Importance of Visual Aid in Pharma Industry
Lecture 164Fundamentals of preparing visual aid
Lecture 165Indications for Drugs: Approved vs. Non-approved
Lecture 166Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 167Step by step visual aid development process
Lecture 168Guideline of Visual Aid Designing
Lecture 169Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 170Visual Aid Printing
Lecture 171Detailing and e-detailing
Lecture 172Visual Aid Development
Lecture 173Visual Aid, Literature reference Sample
Lecture 174Tablet vs. Conventional Detailing
Section 19Practical Training on Packaging Development
Lecture 175Artwork Development Process in PMT Department
Lecture 176Product List and Reminder card development
Lecture 177Catch Cover Development
Lecture 178Packaging Development
Lecture 179Prescribing Information and Patient Information Leaflet development
Lecture 180Pharma Packaging Case Studies
Section 20Analytics
Lecture 181Moving annual total (MAT)
Lecture 182Compound Annual Growth Rate (CAGR)
Lecture 183Analytical Approach in Determining Brand Potential with case study
Section 21Strategic Sessions
Lecture 184Co-promotion & Co-marketing strategy
Lecture 185Concept of Reverse co-promotion in pharma industry
Lecture 186In-Licensing Vs. Outlicensing
Lecture 187Importance of Publications in Pharmaceutical Industry
Lecture 188Juxtapid Case Study
Lecture 189New 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