TypeOnline Course
Price$790 / Rs. 38500
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Admission Process

Admission Process

Upon receiving your filled up application form, our admin team will generate PROVISIONAL ADMISSION ID and send you the PROVISIONAL ADMISSION LETTER along with instruction to course fees payment options.

Course Application Form

This course will cover complete ADVANCE DIPLOMA IN DRUG REGULATORY AFFAIRS AND ADVANCE DIPLOMA IN PRODUCTION MANEGEMENT under single course. All content of regulatory affairs and production management course will be covered under this.

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 marketing can pursue the course.

Features of the Course:

1. Comprehensive study material covering all important aspects of Pharmaceutical Production and Regulatory Affairs.

2. Understanding/ Decision Making/ Strategy Creation in the field of Pharma Production and Regulatory Affairs

3. 143 Case Live Pharmaceutical Production and Regulatory Case studies.

4. Support : Resume Development, Placement Assistance.

Course Duration: 1 Year

Nature of the Course: Distance & e-Learning

Unique Features:

  • 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

Learning Mode:

  • Interactive e-lectures (virtual classroom)
  • Online interactive sessions with the expert Industry faculty
  • e-Library and e-pharma dictionary
  • Access to 1000’s of real life case studies
  • Online assignments & self Assessment Test
  • Printed Course Material
  • 24/7 Online Support With the Live Chat Facility
  • Special On demand Modules
  • Secure access to e-module with passwords.
  • Flexible online final examination (Computer Based Test by secure mode)
  • 100% Placement assistance is provided once the course is completed
  • The Internationally Accredited course – Approved by International Association of Distance Learning (IADL), UK
  • Personalized web page
  • Our courses can be accessed anytime from anywhere

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 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 2Fundamental of Clinical Trials
Lecture 18Clinical Trials Terminologies
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent
Section 3IPR related topics
Lecture 22Functions of the United States Patent and Trademark Office
Lecture 23Patent
Lecture 24Patent - Practical on search and filing
Lecture 25Trademark - Practical on TM Search & Registration Process
Lecture 26Trademark - Practical on TM Search
Lecture 27Trademark Search assignment
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 - Practical on TM Search & Registration Process in India (Optional)
Lecture 31Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 32Regulatory Strategies in different phases of Clinical Trial
Lecture 33Advance study on Para IV Filing
Lecture 34Evergreening - Patent Life Extension Strategies
Lecture 35Drug Repurposing
Lecture 36Pay For Delay Strategy
Section 5Good Manufacturing Practices
Lecture 37GMP
Lecture 38Certification Pharmaceutical Companies / Plants
Lecture 39Introduction to Good Manufacturing Practices
Lecture 40G1 Lecture Premises & Plant Layout Designing
Lecture 41G2 Lecture Sanitation and Hygiene
Lecture 42G3 Lecture Equipment Modules
Lecture 43G4 Lecture Production Modules
Lecture 44G5 Lecture Documentation
Lecture 45G6 Lecture Quality Control
Lecture 46G7 Lecture Product Complaint
Lecture 47G8 Lecture Storage Module
Lecture 48ISO and ISO Audits
Lecture 49Pharmaceutical SOPs Management from regulatory perspective
Lecture 50SOP Automation in Pharmaceutical Industry
Section 6DMF & SMF
Lecture 51DMF & SMF
Lecture 52Site Master File
Lecture 53Practical Training on preparing DMF and SMF
Section 7Biosimilar Regulatory Affairs
Lecture 54Introduction to Biosimilar
Lecture 55Biosimilar Approval process
Lecture 56Biological Licensing Application (BLA)
Lecture 57Vaccine development and approval Process
Section 8USFDA warning Letter & CAPA
Lecture 58CAPA - Introduction
Lecture 59USFDA Warning Letter
Lecture 60Handling of warning letter
Lecture 61Case Study: Warning Letter for The Halol plant of Sun Pharma
Section 9EU Regulatory Affairs
Lecture 62Introduction to EU Regulation
Lecture 63Orientation to European Countries and National Regulatory Bodies
Lecture 64Overview of EU Regulation
Lecture 65EMEA Procedures
Lecture 66Summary of Product Characteristics
Lecture 67Compassionate Use
Lecture 68MHRA - UK Regulation
Lecture 69EU Orphan Medicinal Products Regulation
Section 10Drug Dossier
Lecture 70Introduction to Common Technical Document (CTD)
Lecture 71Asean Common Technical Document (ACTD)
Lecture 72Introduction to Electronic Common Technical Document (ECTD)
Lecture 73Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 74Modules on Stability Study 1
Lecture 75Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Section 11Portfolio Management - Strategic Point of View
Lecture 76Advance understanding of the portfolio Management
Lecture 77Importance of market research in pharmaceutical industry
Lecture 78Co-promotion & Co-marketing strategy in pharma industry
Lecture 79Concept of Reverse co-promotion in pharma industry
Lecture 80In-Licensing Vs. Outlicensing
Lecture 81Publication Management from Regulatory perspective
Lecture 82Juxtapid Case Study
Lecture 83New Indication Approval Process and Promotion
Lecture 84OTC Switch
Lecture 85Practical 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 88P1 Introduction to Production Management
Lecture 89P2 TYPES OF PRODUCTION & Classification
Lecture 90P3 Productivity Concept of measuring success
Lecture 91P4 Factors affecting productivity
Lecture 92P5 Industrial efficiency
Lecture 93P6 Concept of Efficiency, Effectiveness and Productivity
Lecture 94P7 Production Management Review Test
Lecture 95P8 Introduction to ERGONOMICS
Lecture 96P9 Concept of work designing
Lecture 97P10 Production Planning - Objective and Importance
Lecture 98P11 Production Planning Steps and Control
Lecture 99P12 Control Chart
Lecture 100P13 Quality Control
Lecture 102P15 Plant Layout
Lecture 103P16 Material Management - Introduction
Lecture 104P17 Inventory Management
Section 15Production Management - Pharmaceutical Dosage Forms and Manufacturing Process
Section 16Final Examination