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production regulatory affairs dual specialization




Unique Features

Admission Process

Course Deliverable

This online certification course will cover complete ADVANCE PG DIPLOMA IN DRUG REGULATORY AFFAIRS AND ADVANCE PG DIPLOMA IN PRODUCTION MANEGEMENT under single course. Entire syllabus of Regulatory Affairs (as a single course) and also Pharmaceutical Production Management topics will be covered under this program.

Course Code: KPE-C-021
Course: KPE’s Advance Diploma in Pharmaceutical Production Management and Drug Regulatory Affairs (Dual Specialization)
Course Duration: 1 Year
Nature of the Course: Distance & e-Learning

Course Objectives:

Our Registerants are in Lipoxen (UK), Orchid, Sanofi-Aventis, Astra-Zeneca, Hospira, Ranbaxy, Julphar, J&J-Ethicon, Pfizer, DRL, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, Shaigan Pharmaceuticals, Reliance Lifesciences, Quality Pharma Pvt Ltd, Cipla, Ipca, Sherya Lifesciences, Promed, Torrent Pharmaceuticals, Zydus Candila, Himalaya Herbal Healthcare, Bangalore Pharmaceutical and Research laboratories, Teru Technomed, Indocoar Pharma, Fortis Hospitals, VRPL Healthcare, Medreich, Hospira, Indospectrum, Winatac Limited, Faveo Pharmaceuticals, Enzem, Leo, Accenture, Mylan, and many more companies across the pharma industry.

1 Year.

B.Pharma/D.Pharma/ B.Sc/ Any graduates or Post Graduates or Phd holder, who want to broaden the career skill in drug regulatory affairs can pursue the course. Minimum 2 years experience required for admission.

Unique Features of this dual specialization course

  • Comprehensive study material covering all aspects of drug regulatory affairs will be covered under this course.
  • Comprehensive study material covering all important aspects of Pharmaceutical Production.
  • Orientation to job related practical aspects of Pharmaceutical Production and drug regulatory affairs.
  • Access to industry data bank of Standard Operating Procedures (SOPs) for different equipment.
  • Specialized modules covering all Pharmaceutical Dosage Forms.
  • Specialized modules on GMP, ISO guidelines as well as handling of GMP and ISO audits.
  • Special module on Production related regulatory affairs.
  • Support : Resume Development.


Frequently asked questions

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  • Participant will be receiving PDF books (which can be downloaded and save in the own system).
  • Online access to the course modules, lectures, simulations as mentioned in the course flow below.
  • While attending online lectures, participant will able to download the lecture handouts.
  • Personalized webpage will be issued to all participant where you can track the course performance, feedback, comments and assistance from mentors and support staffs.

Course Flow – 

Section 1Fundamental of Drug Discovery, Development (US Regulation)
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
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 7Complete Response Letter | Key understanding | Management and Action Plan
Lecture 8Generic Drug User Fees Act  (GDUFA)
Lecture 9Prescription Drug User Fees Act (PDUFA)
Lecture 10Handling of orange book
Lecture 11USFDA expedited programs
Lecture 12Practical Training on INDA, NDA, ANDA filing
Lecture 13505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 14Authorized Generics: Key Understanding
Lecture 15Exploratory IND Vs. Traditional IND
Lecture 16Patents Vs. exclusivity 
Lecture 17Orphan Drug Designation 
Lecture 18Advance Learning on 505B2 Pathway
Lecture 19Chemistry, Manufacturing & Controls 
Lecture 20Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 21Review on Drug Discovery and Development 
Section 2Fundamental of Clinical Trials
Lecture 22Clinical Trials Terminologies
Lecture 23Clinical Trial Protocol Writing
Lecture 24Ethics in Clinical Research
Lecture 25Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 26FDA Forms and How to fill the resources
Lecture 27Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 28Clinical Trial Failure: Lack of Efficacy - Case Study
Lecture 29Clinical Trial Failure: Lack of Efficacy - Case Study
Section 3Innovation Management : Intellectual Property Right Management Topics
Lecture 30Introduction to intellectual Property Management
Lecture 31Patent
Lecture 32Understanding on Patent System
Lecture 33Patent Grant and Managing Patent Filing Procedure
Lecture 34Scope of Patentability 
Lecture 35Patent Grant and Handling Process
Lecture 36Stages of Patent Grant Procedure
Lecture 37Patent search in Indian Patent Office
Lecture 38Differences in US and European Patent
Lecture 39Patent Claim | Types of Patent Claims 
Lecture 40Patent Cliff | How to calculate the patent cliff
Lecture 41Terminologies related to patent, trademark, copyright and licensing 
Lecture 42Patent Infringement
Lecture 43Introduction to Trademark | Trademark filing procedure
Lecture 44Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 45Trademark Infringement | Passing off | Practical Cases
Lecture 46Trademark Classes | How to search the right trademark class for for filing trademark application
Section 4Regulatory Strategies
Lecture 47Regulatory Strategies in different phases of Clinical Trial
Lecture 48Advance study on Para IV Filing
Lecture 49Para IV Notices
Lecture 50Evergreening - Patent Life Extension Strategies
Lecture 51Pay For Delay Strategy
Lecture 52REMS Strategic Planning 
Lecture 53Compulsory Licensing
Lecture 54Licensing & Technology Transfer
Lecture 55In-Licensing Vs. Outlicensing
Lecture 56LOE Strategies for Innovator Brands with case study
Lecture 57Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 58Drug Repurposing
Lecture 59Practical Queries on different USFDA application and Filing 
Section 5Good Manufacturing Practices
Lecture 60GMP
Lecture 61Certification Pharmaceutical Companies / Plants
Lecture 62Introduction to Good Manufacturing Practices
Lecture 63G1 Lecture Premises & Plant Layout Designing
Lecture 64G2 Lecture Sanitation and Hygiene
Lecture 65G3 Lecture Equipment Modules
Lecture 66G4 Lecture Production Modules
Lecture 67G5 Lecture Documentation
Lecture 68G6 Lecture Quality Control
Lecture 69G7 Lecture Product Complaint
Lecture 70G8 Lecture Storage Module
Lecture 71ISO and ISO Audits
Lecture 72Pharmaceutical SOPs Management from regulatory perspective
Lecture 73SOP Automation in Pharmaceutical Industry
Section 6DMF & SMF
Lecture 74Key Consideration for Drug Master File Preparation and Submission 
Lecture 75Practical Understanding on Drug Master File Preparation and Submission
Lecture 76Associated Learning: Site Master File - Detailed Understanding 
Lecture 77DMF Completeness Assessment
Lecture 78Drug Master File - Fees
Lecture 79Drug Master File - Global Perspective [Across Different Regions]
Section 7Biosimilar Regulatory Affairs
Lecture 80Introduction : Biopharmaceuticals
Lecture 81Classification of Biopharmaceutical 
Lecture 82Introduction to Biosimilar 
Lecture 83Chemical Drugs Vs. Biologic Drugs
Lecture 84Principle of Naming of Biologics
Lecture 85Current Trends in Biopharmaceutical Market
Lecture 86Present Encouraging Factors for Biopharmaceutical Industry
Lecture 87Complexity of biopharma supply chain and operations
Lecture 88Global Biologics Market - Classes and market share
Lecture 89Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 90Recombinant protein
Lecture 91Monoclonal Antibodies
Lecture 92Synthetic Immunomodulators
Lecture 93Production of Monoclonal Antibodies
Lecture 94Cytokines
Lecture 95Interferon
Lecture 96Erythropoiesis-stimulating agent
Lecture 97Biological Licensing Application (BLA) 
Lecture 98Biosimilar Approval process
Lecture 99Vaccine development and approval Process
Lecture 100Review : 351(a) vs. 351(k) pathway
Lecture 101Biosimilar Development Process
Lecture 102Strategic Consideration for Biosimilar Development 
Lecture 103Bio-Manufacturing Process Information
Section 8USFDA warning Letter & CAPA
Lecture 104Data Integrity issues in Pharmaceutical Industry
Lecture 105USFDA Warning Letter
Lecture 106Handling of warning letter
Lecture 107Case Study: Warning Letter for The Halol plant of Sun Pharma
Lecture 108CAPA
Section 9EU Regulatory Affairs
Lecture 109Introduction to EU Regulation
Lecture 110Orientation to European Countries and National Regulatory Bodies
Lecture 111Overview of EU Regulation
Lecture 112EMEA Procedures
Lecture 113Summary of Product Characteristics
Lecture 114Compassionate Use
Lecture 115MHRA - UK Regulation
Lecture 116EU Orphan Medicinal Products Regulation
Section 10Drug Dossier
Lecture 117Introduction to Common Technical Document (CTD)
Lecture 118CMC Dossier & Compliance Management
Lecture 119Introduction to Electronic Common Technical Document (ECTD)
Lecture 120Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 121Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 122Review Test on Stability Testing 
Lecture 123Black Box Warning
Lecture 124Importance of effective dossier management
Lecture 125Deficiencies observed in CTD Dossiers:
Lecture 126Certificate of Analysis
Lecture 127Detailed Understanding on ANDA Submission Dossier 
Lecture 128Prior Approval Submission 
Lecture 129Detailed Understanding on ANDA Fees
Lecture 130Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 131NCE Vs. 505b2 application - Case Based Learning 
Lecture 132FTF - 180 Days Exclusivity - Case Based Learning
Lecture 133Classic case study of the 505b2 filing : Case Based Learning
Lecture 134Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 135Asean Common Technical Document (ACTD) 
Lecture 136Discussionon 85 common deficiency in CTD submission dossier
Section 11Portfolio Management - Strategic Point of View
Lecture 137Advance understanding of the portfolio Management
Lecture 138Importance of market research in pharmaceutical industry
Lecture 139Co-promotion & Co-marketing strategy in pharma industry
Lecture 140Concept of Reverse co-promotion in pharma industry
Lecture 141In-Licensing Vs. Outlicensing
Lecture 142Publication Management from Regulatory perspective
Lecture 143Juxtapid Case Study
Lecture 144New Indication Approval Process and Promotion
Lecture 145OTC Switch
Lecture 146Practical Case Study in Rx to OTC Switch
Section 12API Regulatory Affairs
Section 1348 different topics of the Regulatory Affairs, Case Studies and Self Assessment Tests
Section 14Basic Fundamentals of Pharmaceutical Production Management
Lecture 149P1 Introduction to Production Management
Lecture 150P2 TYPES OF PRODUCTION & Classification
Lecture 151P3 Productivity Concept of measuring success
Lecture 152P4 Factors affecting productivity
Lecture 153P5 Industrial efficiency
Lecture 154P6 Concept of Efficiency, Effectiveness and Productivity
Lecture 155P7 Production Management Review Test
Lecture 156P8 Introduction to ERGONOMICS
Lecture 157P9 Concept of work designing
Lecture 158P10 Production Planning - Objective and Importance
Lecture 159P11 Production Planning Steps and Control
Lecture 160P12 Control Chart
Lecture 161P13 Quality Control
Lecture 163P15 Plant Layout
Lecture 164P16 Material Management - Introduction
Lecture 165P17 Inventory Management
Section 15Production Management - Pharmaceutical Dosage Forms and Manufacturing Process
Lecture 166Manufacturing Process - Learning Session 1
Lecture 167Manufacturing Process - Learning Session 2
Lecture 168Manufacturing Process - Learning Session 3
Lecture 169Pharma Production Flow Charts
Section 16Export Management : Understanding on Export Business and Documentations
Lecture 170Introduction to Pharmaceutical Export
Lecture 171Introduction of Export Documentation | Understanding of important terminologies
Lecture 172Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 173Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 174Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 175Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 176Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 177Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 178LC Discounting | How it works | How to calculate the LC discounting
Lecture 179Packing List | Importance | Things to include in packing list
Lecture 180Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 181Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 182Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 183Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 184Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation