TypeOnline Course
Student Enrolled9
(10 ratings)
Price$650 / Rs. 32500
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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.

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Admission Process

Course Objectives:

Pharmaceutical Regulatory Affairs courses are conceptualized with vision to create effective Regulatory Affairs Manager for Pharma Industry. This course gives practical knowledge of the functionalities of Regulatory Manager with practical exposure.

Career in Drug Regulatory Affairs

A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals.

The Pharma industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products. To maintain safety and efficacy in pharma & medical device products, regulatory agencies like US FDA,UK MHRA, EDQM, DCGI etc all over the world are imposing no of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease.

 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. Printed Book / printable booklet provided to all course participants. There will be total 18 books will be provided. Refer syllabus copy to view the details. 

2. Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage. 

3. Flexible online final examination (Computer Based Test by secure mode)

4. Access to 1000s of real life case studies

B.Pharma/D.Pharma/ 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.


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Course Flow – 

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
Lecture 15Patents Vs. exclusivity
Lecture 16Case Study New Drug Development & R&D Incentive Plans
Lecture 17Submission Requirements for Orphan Drug Designation
Lecture 18Advance Learning on 505B2 Pathway
Section 2Clinical Trial / Research - Fundamental
Lecture 19Clinical Trial Detailed Study (Topic - 1-11)
Lecture 20Clinical Trial Protocol Writing
Lecture 21Ethics in Clinical Research
Lecture 22Informed Consent
Lecture 23FDA forms and How to fill FDA forms
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 Search in Indian Patent Office (Optional)
Lecture 32Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 33Trademark Search assignment (optional)
Lecture 34Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 35Regulatory Strategies in different phases of Clinical Trial
Lecture 36Advance study on Para IV Filing
Lecture 37Para IV Notice
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 Re-purposing
Section 5GMP
Lecture 47Definition of GMP
Lecture 48Certification Pharmaceutical Companies / Plants
Lecture 49Introduction to Good Manufacturing Practices
Lecture 50Premises & Plant Layout Designing
Lecture 51Sanitation and Hygiene
Lecture 52Equipment
Lecture 53Production Modules
Lecture 54GMP Documentation
Lecture 55Quality Control
Lecture 56Handling of Product Complaint
Lecture 57GMP Storage
Lecture 58ISO and ISO Audits
Lecture 59Pharmaceutical SOPs
Lecture 60SOP Automation
Section 6Drug Master File & Site Master File
Lecture 61Key Consideration for Drug Master File Preparation and Submission 
Lecture 62Practical Understanding on Drug Master File Preparation and Submission
Lecture 63Site Master File - Detailed Understanding 
Lecture 64DMF Completeness Assessment
Lecture 65Drug Master File - Fees
Lecture 66Drug Master File - Global Perspective [Across Different Regions]
Section 7Biopharmaceutical Regulation [Innovator & Biosimilar]
Lecture 67Introduction : Biopharmaceuticals
Lecture 68Classification of Biopharmaceutical 
Lecture 69Introduction to Biosimilar 
Lecture 70Chemical Drugs Vs. Biologic Drugs
Lecture 71Principle of Naming of Biologics
Lecture 72Current Trends in Biopharmaceutical Market
Lecture 73Present Encouraging Factors for Biopharmaceutical Industry
Lecture 74Complexity of biopharma supply chain and operations
Lecture 75Biopharma Market Segmentation
Lecture 76Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 77Recombinant protein
Lecture 78Monoclonal Antibodies
Lecture 79Synthetic Immunomodulators
Lecture 80Production of Monoclonal Antibodies
Lecture 81Cytokines
Lecture 82Interferon
Lecture 83Erythropoiesis-stimulating agent
Lecture 84Biological Licensing Application (BLA) 
Lecture 85Biosimilar Approval process
Lecture 86Vaccine development and approval Process
Lecture 87Review : 351(a) vs. 351(k) pathway
Lecture 88Biosimilar Development Process
Lecture 89Strategic Consideration for Biosimilar Development 
Lecture 90Bio-Manufacturing Process Information
Section 8USFDA warning Letter & CAPA
Lecture 91CAPA - Introduction
Lecture 92USFDA Warning Letter
Lecture 93Handling of warning letter
Lecture 94Case Study: Warning Letter
Section 9Drug Registration in European Country (Optional)
Lecture 95Overview of EU Regulation
Lecture 96Orientation to European Countries and National Regulatory Bodies
Lecture 97Overview of EU Regulation
Lecture 98EMEA Procedures
Lecture 99Summary of Product Characteristics (SmPC)
Lecture 100Compassionate Use
Lecture 101MHRA - UK Regulation
Lecture 102EU Orphan Medicinal Products Regulation
Lecture 103The 'sunset clause' for marketing authorisations of pharmaceuticals
Section 10GCC Regulatory Affairs (Optional)
Lecture 104Regions in Pharma Business : Common Terminologies
Lecture 105GCC Pharma Market
Lecture 106GCC Export
Lecture 107GCC Registration Procedure
Lecture 108Drug Registration in Saudi Arabia
Lecture 109Documentation Required for the GCC countries
Lecture 110Drug Registration in Beherain, UAE, Kuwait, Qatar, Oman
Lecture 111Medical Device Regulation in GCC countries
Section 11Innovator Drug Registration Dossier and Generic Submission
Lecture 112Introduction to Common Technical Document (CTD)
Lecture 113Asean Common Technical Document (ACTD)
Lecture 114ECTD
Lecture 115Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 116Modules on Stability Study
Lecture 117Stability Study Test
Lecture 118Module on Interchangeability
Lecture 119Stability Testing of API
Lecture 120Stability Testing of Finished Pharmaceutical Products
Lecture 121Review on Stability Testing
Lecture 122Black Box Warning
Lecture 123Importance of effective dossier management
Lecture 124Deficiencies observed in CTD Dossiers
Lecture 125Certificate of Analysis
Lecture 126Detailed Understanding on ANDA Submission Dossier 
Lecture 127Prior Approval Submission 
Lecture 128Detailed Understanding on ANDA Fees
Lecture 129505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 130NCE Vs. 505b2 application - Case Based Learning 
Lecture 131FTF - 180 Days Exclusivity - Case Based Learning
Lecture 132Classic case study of the 505b2 filing
Lecture 133Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Section 12Portfolio Management and Related Topics
Lecture 134Advance understanding of the portfolio Management
Lecture 135Importance of market research in pharmaceutical industry
Lecture 136Co-promotion & Co-marketing strategy in pharma industry
Lecture 137Concept of Reverse co-promotion in pharma industry
Lecture 138Publication Management from Regulatory perspective
Lecture 139Juxtapid Case Study
Lecture 140New Indication Approval Process and Promotion
Lecture 141OTC Switch
Lecture 142Practical Case Study in Rx to OTC Switch
Section 13API Regulatory Affairs
Section 14Case Study Access
Lecture 14448 different topics of the Regulatory Affairs, Case Studies and Self Assessment Tests
Lecture 145Access to Case study directory
Section 15Drug Registration in ASEAN countries (Optional)
Lecture 146ASEAN Drug Regulatory Affairs
Lecture 147Asean Geography
Lecture 148Drug Registration in Brunei
Lecture 149Drug Registration in Malaysia
Lecture 150Drug Registration in Cambodia
Lecture 151Drug Registration in Mayanmar
Lecture 152Drug Registration in Philippines
Lecture 153Drug Registration in Singapore
Section 16CDSCO : Drug Registration in India (Optional)
Lecture 154Drug Regulation in India - CDSCO
Lecture 155National Pharmaceutical Pricing Authority
Lecture 156Drug Price Regulation in India
Lecture 157Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 158Drug Price Control Order 2013
Lecture 159Case Study of New Drug Approval in India
Section 17Final Examination
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