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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 69Biosimilar
Lecture 70Biosimilar Approval process
Lecture 71Biological Licensing Application (BLA)
Lecture 72Vaccine development and approval Process
Section 8USFDA warning Letter & CAPA
Lecture 73Data Integrity issues in Pharmaceutical Industry
Lecture 74Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 75Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 9Drug Registration in European Country (Optional)
Lecture 76Introduction to EU Regulation
Lecture 77Orientation to European Countries and National Regulatory Bodies
Lecture 78Overview of EU Regulation
Lecture 79EMEA Procedures
Lecture 80Summary of Product Characteristics
Lecture 81Compassionate Use
Lecture 82MHRA - UK Regulation
Lecture 83EU Orphan Medicinal Products Regulation
Section 10GCC Drug Regulatory Affairs
Lecture 84Regions in Pharma Business : Common Terminologies
Lecture 85GCC Pharma Market
Lecture 86GCC Export
Lecture 87GCC Registration Procedure
Lecture 88Drug Registration in Saudi Arabia
Lecture 89Documentation Required for the GCC countries
Lecture 90Drug Registration in Saudi Arabia
Lecture 91Medical Device Regulation in GCC countries
Lecture 92Drug Registration in UAE
Lecture 93Drug Registration in Kuwait
Lecture 94Drug Registration in Bahrain
Lecture 95Drug Registration in Oman
Section 11Drug Registration Dossier
Lecture 96Introduction to Common Technical Document (CTD)
Lecture 97Asean Common Technical Document (ACTD)
Lecture 98Introduction to Electronic Common Technical Document (ECTD)
Lecture 99Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 100Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 101Chemistry, Manufacturing & Controls - Fundamental Understanding 
Lecture 102CMC Dossier & Compliance Management
Lecture 103Black Box Warning
Lecture 104Importance of effective dossier management
Lecture 105Deficiencies observed in CTD Dossiers
Lecture 106Certificate of Analysis
Lecture 107Detailed Understanding on ANDA Submission Dossier 
Lecture 108Prior Approval Submission 
Lecture 109Detailed Understanding on ANDA Fees
Lecture 110Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 111NCE Vs. 505b2 application - Case Based Learning 
Lecture 112FTF - 180 Days Exclusivity - Case Based Learning
Lecture 113Classic case study of the 505b2 filing : Case Based Learning
Lecture 114Discussion on 85 common deficiency in CTD submission dossier
Lecture 115Data Integrity issues in Pharmaceutical Industry
Section 12ASEAN Drug Regulatory Affairs
Lecture 116Introduction
Lecture 117Asean Geography
Lecture 118Drug Registration in Brunei
Lecture 119Drug Registration in Malaysia
Lecture 120Drug Registration in Cambodia
Lecture 121Drug Registration in Mayanmar
Lecture 122Drug Registration in Philippines
Lecture 123Drug Registration in Singapore
Section 13Drug Regulation in India - CDSCO
Lecture 124Drug Regulation in India - CDSCO
Lecture 125National Pharmaceutical Pricing Authority
Lecture 126Drug Price Regulation in India
Lecture 127Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 128Drug Price Control Order 2013
Lecture 129Case Study of New Drug Approval in India
Section 14Introduction: Pharma Product Management
Lecture 130Career in Pharma Product Management
Lecture 131Detailed Understanding of Product Management Job
Section 15Fundamentals of Pharma Marketing
Lecture 132Marketing Orientation for Product Manager
Lecture 133Why Is Market Research Important in Pharmaceutical Business?
Lecture 134Product Life cycle - Basic Understanding
Lecture 135Concept of STP
Lecture 136Pricing
Lecture 137Distribution Channel in Pharmaceutical Industry 
Lecture 138Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 139A Pharmaceutical Segmentation outlook
Lecture 140Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 141Method of Promotional Budgeting
Lecture 142Basics of Advertising : Introduction
Lecture 143The Advertising agency Selection Process with Case Based Learning on Creative Brief Preparation
Lecture 144Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 145Advertising Planning - ATL, BTL, TTL activities
Section 16Practical Training on Pharma Brand Logo Development
Lecture 146Brand Logo - Introduction
Lecture 147Purpose of Brand Logo
Lecture 148Component of Brand Logo
Lecture 149Brand Name and TM Registration Process
Lecture 150Trademark - Practical on TM Search
Lecture 151Trademark Search assignment
Lecture 152Trademark Registration in US
Lecture 153How to design excellent brand logo?
Lecture 154Color Systems - RGB & CMYK
Lecture 155Few Case Studies related to brand names and logos
Lecture 156Brand Logo - Simulation
Lecture 157Colour Trademarking in Pharma Branding
Lecture 158How to protect pharma brands globally?
Lecture 159Rebranding Exercise in Pharmaceutical Industry
Lecture 160Brand Logo Development: Real Life Simulation
Section 17Marketing Plan / Brand Plan Fundamentals
Lecture 161 Basic Understanding how to launch a pharmaceutical product into the market
Lecture 162Marketing Campaign Development
Lecture 163How to prepare a Pharma Brand Plan
Lecture 164Marketing Plan : Sample Plan - Glimiperide + Metformin
Lecture 165Decide about brand USP -What to promote
Lecture 166How to prepare promotogram. Download sample Promotogram
Lecture 167Importance and Handling of Cycle Meeting and its importance
Lecture 168Sample Marketing Plan : Febuxostat
Lecture 169Sample Marketing Plan : Pregabalin
Lecture 170Sample Marketing Plan : Pregabalin
Lecture 171New Product Launch Case Study
Lecture 172Aristada - Launch Case Study
Lecture 173CSR Campaign
Lecture 174Sample Allocation Planning
Section 18Practical Training on Visual Aid Development
Lecture 175Importance of Visual Aid in Pharma Industry
Lecture 176Fundamentals of preparing visual aid
Lecture 177Indications for Drugs: Approved vs. Non-approved
Lecture 178Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 179Step by step visual aid development process
Lecture 180Guideline of Visual Aid Designing
Lecture 181Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 182Visual Aid Printing
Lecture 183Detailing and e-detailing
Lecture 184Visual Aid Development
Lecture 185Visual Aid, Literature reference Sample
Lecture 186Tablet vs. Conventional Detailing
Section 19Practical Training on Packaging Development
Lecture 187Artwork Development Process in PMT Department
Lecture 188Product List and Reminder card development
Lecture 189Catch Cover Development
Lecture 190Packaging Development
Lecture 191Prescribing Information and Patient Information Leaflet development
Lecture 192Pharma Packaging Case Studies
Section 20Analytics
Lecture 193Moving annual total (MAT)
Lecture 194Compound Annual Growth Rate (CAGR)
Lecture 195Analytical Approach in Determining Brand Potential with case study
Section 21Strategic Sessions
Lecture 196Co-promotion & Co-marketing strategy
Lecture 197Concept of Reverse co-promotion in pharma industry
Lecture 198In-Licensing Vs. Outlicensing
Lecture 199Importance of Publications in Pharmaceutical Industry
Lecture 200Juxtapid Case Study
Lecture 201New Indication Approval Process and Promotion
Section 22Basic Finance for Pharma managers
Section 23Case Study Directory
Section 24Marketing Strategy Related Sessions
Lecture 204Increase the brand reach with advance segmentation
Lecture 205Concept of uniform branding for better brand acceptability
Lecture 206Brand Line Extension : Importance and Strategic Planning 
Lecture 207Disease Awareness Campaign - Brand Building Activities on Specific Health Day
Lecture 208Medical Animation for Brand Building 
Lecture 209Celebrity Endorsement in Pharmaceutical Brand Promotion
Lecture 210Celebrity Endorsement Vs. Bootlegging 
Lecture 211Promotion Advertisement Regulations
Lecture 212Importance of Sponsoring Medical Conference: Promotion of Pharmaceutical Brands in Medical Conferences
Lecture 213Conference Banner Designing
Lecture 214Roll Up Standee