TypeOnline Course
Student Enrolled3
(10 ratings)
Price$650 / Rs. 32500
Buy NowBook Now

Admission Process

Sign in or create account at www.nckpharma.com with all details and make the course fees payment to start the course

Sign Up Now

Regulatory Affairs Course Comparison

View course content comparison of 1 Week / 1 month / 1 Year program in drug regulatory affairs. This will help you to choose right regulatory affairs course which suits to your requirement.

view Comparison

Introduction

Feature

Eligibility

Admission Process

Course Deliverables

Course Comparison

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 Takeda, Pfizer, GSK, Lipoxen (UK), Patheon, Mylan, Biocon, Micro Lab, GE Lifesciences, Orchid, Sanofi, AstraZeneca, Hospira, Ranbaxy, Julphar, Jhonson and Jhonson, Ethicon, Dr. Reddy’s Laboratory, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, 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, Wintac Limited, Faveo Pharmaceuticals, Enzem, Leo Pharma, Accenture, Shaigan Pharmaceutical, Ceutica & Chemie, Medxplor Healthcare, Systopic Laboratories and many more companies across the pharma industry.

  • 24×7 Online Access – Access anytime from anywhere across globe.
  • 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. 
  • Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage. 
  • Flexible online final examination (Computer Based Test by secure mode)
  • 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.

FAQ RELATED TO THE COURSE

Frequently asked questions

Read FAQs

ADMISSION PROCESS

View course content comparison of 1 Week / 1 month / 1 Year program in drug regulatory affairs. This will help you to choose right regulatory affairs course which suits to your requirement.

view Comparison

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 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 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Authorized Generics: Key Understanding
Lecture 13Exploratory IND
Lecture 14Patents Vs. exclusivity
Lecture 15Case Study New Drug Development & R&D Incentive Plans
Lecture 16Submission Requirements for Orphan Drug Designation
Lecture 17Advance Learning on 505B2 Pathway
Lecture 18Chemistry, Manufacturing & Controls 
Lecture 19Patent & Exclusivity - Strategic Understanding | 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 Trial Detailed Study (Topic - 1-11)
Lecture 22Clinical Trial Protocol Writing
Lecture 23Ethics in Clinical Research
Lecture 24Informed Consent
Lecture 25FDA forms and How to fill FDA forms
Lecture 26Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 27Clinical Trial Failure: Lack of Efficacy - Case Study
Lecture 28Clinical Trial Failure: Lack of Efficacy - Case Study
Section 3IPR Related Topics (Optional)
Lecture 29USPTO - Introduction
Lecture 30Patent - Fundamental Concepts
Lecture 31Patent Application Process - USPTO
Lecture 32Trademark Search and Registration in US
Lecture 33Steps Know How & Key Points - Patent Application
Lecture 34IPR - Patent Grant and Handling Process in India (Optional)
Lecture 35Patent Search in Indian Patent Office (Optional)
Lecture 36Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 37Trademark Search assignment (optional)
Lecture 38Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 39Regulatory Strategies in different phases of Clinical Trial
Lecture 40Advance study on Para IV Filing
Lecture 41Para IV Notice
Lecture 42Evergreening - Patent Life Extension Strategies
Lecture 43Pay For Delay Strategy
Lecture 44REMS Strategic Planning
Lecture 45Compulsory Licensing
Lecture 46Technology Licensing
Lecture 47In-Licensing Vs. Outlicensing
Lecture 48LOE Strategies for Innovator Brands with case study
Lecture 49Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 50Drug Re-purposing
Lecture 51Practical Queries on different USFDA application and Filing 
Section 5GMP
Lecture 52Definition of GMP
Lecture 53Certification Pharmaceutical Companies / Plants
Lecture 54Introduction to Good Manufacturing Practices
Lecture 55Premises & Plant Layout Designing
Lecture 56Sanitation and Hygiene
Lecture 57Equipment
Lecture 58Production Modules
Lecture 59GMP Documentation
Lecture 60Quality Control
Lecture 61Handling of Product Complaint
Lecture 62GMP Storage
Lecture 63ISO and ISO Audits
Lecture 64Pharmaceutical SOPs
Lecture 65SOP Automation
Section 6Drug Master File & Site Master File
Lecture 66Key Consideration for Drug Master File Preparation and Submission 
Lecture 67Practical Understanding on Drug Master File Preparation and Submission
Lecture 68Site Master File - Detailed Understanding 
Lecture 69DMF Completeness Assessment
Lecture 70Drug Master File - Fees
Lecture 71Drug Master File - Global Perspective [Across Different Regions]
Section 7Biopharmaceutical Regulation [Innovator & Biosimilar]
Lecture 72Introduction : Biopharmaceuticals
Lecture 73Classification of Biopharmaceutical 
Lecture 74Introduction to Biosimilar 
Lecture 75Chemical Drugs Vs. Biologic Drugs
Lecture 76Principle of Naming of Biologics
Lecture 77Current Trends in Biopharmaceutical Market
Lecture 78Present Encouraging Factors for Biopharmaceutical Industry
Lecture 79Complexity of biopharma supply chain and operations
Lecture 80Biopharma Market Segmentation
Lecture 81Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 82Recombinant protein
Lecture 83Monoclonal Antibodies
Lecture 84Synthetic Immunomodulators
Lecture 85Production of Monoclonal Antibodies
Lecture 86Cytokines
Lecture 87Interferon
Lecture 88Erythropoiesis-stimulating agent
Lecture 89Biological Licensing Application (BLA) 
Lecture 90Biosimilar Approval process
Lecture 91Vaccine development and approval Process
Lecture 92Review : 351(a) vs. 351(k) pathway
Lecture 93Biosimilar Development Process
Lecture 94Strategic Consideration for Biosimilar Development 
Lecture 95Bio-Manufacturing Process Information
Section 8Data Integrity and Consequences : Effective Management of Data Integrity Issues
Lecture 96Data Integrity issues in Pharmaceutical Industry
Lecture 97EIR | 483 Observations | Warning Letter | Handling of FDA inspection
Lecture 98Handling of warning letter
Lecture 99Case Study: Warning Letter
Lecture 100CAPA - Importance and principle
Lecture 101Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 9Drug Registration in European Country (Optional)
Lecture 102Introduction to EU Regulation 
Lecture 103Orientation to European Countries and National Regulatory Bodies
Lecture 104EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 105Overview of EU Regulation 
Lecture 106EMA and EMA Authorisation Process
Lecture 107EU MA Application Types and Strategic Planning
Lecture 108EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 109EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 110Validity of the EU MA  - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 111Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 112EU Orphan Medicinal Products Regulation
Lecture 113Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 114Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 115Summary of Product Characteristics 
Lecture 116Compassionate Use
Lecture 117MHRA - UK Regulation 
Lecture 118The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 119Accelerated assessment by EMEA
Lecture 120Master Data Maintenance by EMEA
Lecture 121EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 122EU Prime Designation
Lecture 123EU Adaptive Pathway
Lecture 124European public assessment report (EPAR) - Importance, Component, Management, Updation 
Section 10GCC Regulatory Affairs (Optional)
Lecture 125Regions in Pharma Business : Common Terminologies
Lecture 126GCC Pharma Market
Lecture 127GCC Export
Lecture 128GCC Registration Procedure
Lecture 129Drug Registration in Saudi Arabia
Lecture 130Documentation Required for the GCC countries
Lecture 131Drug Registration in Beherain, UAE, Kuwait, Qatar, Oman
Lecture 132Medical Device Regulation in GCC countries
Section 11Innovator Drug Registration Dossier and Generic Submission
Lecture 133Introduction to Common Technical Document (CTD)
Lecture 134CMC Dossier & Compliance Management
Lecture 135ECTD
Lecture 136Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 137Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 138Review on Stability Testing
Lecture 139Black Box Warning
Lecture 140Importance of effective dossier management
Lecture 141Deficiencies observed in CTD Dossiers
Lecture 142Certificate of Analysis
Lecture 143Detailed Understanding on ANDA Submission Dossier 
Lecture 144Prior Approval Submission 
Lecture 145Detailed Understanding on ANDA Fees
Lecture 146505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 147NCE Vs. 505b2 application - Case Based Learning 
Lecture 148FTF - 180 Days Exclusivity - Case Based Learning
Lecture 149Classic case study of the 505b2 filing
Lecture 150Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 151Asean Common Technical Document (ACTD) 
Lecture 152Discussion on 85 common deficiency in CTD submission dossier
Section 12Portfolio Management and Related Topics
Lecture 153Advance understanding of the portfolio Management
Lecture 154Importance of market research in pharmaceutical industry
Lecture 155Co-promotion & Co-marketing strategy in pharma industry
Lecture 156Concept of Reverse co-promotion in pharma industry
Lecture 157Publication Management from Regulatory perspective
Lecture 158Juxtapid Case Study
Lecture 159New Indication Approval Process and Promotion
Lecture 160OTC Switch
Lecture 161Practical Case Study in Rx to OTC Switch
Section 13API Regulatory Affairs
Section 14Case Study Access
Lecture 16348 different topics of the Regulatory Affairs, Case Studies and Self Assessment Tests
Lecture 164Access to Case study directory
Section 15Drug Registration in ASEAN countries (Optional)
Lecture 165ASEAN Drug Regulatory Affairs
Lecture 166Asean Geography
Lecture 167Drug Registration in Brunei
Lecture 168Drug Registration in Malaysia
Lecture 169Drug Registration in Cambodia
Lecture 170Drug Registration in Mayanmar
Lecture 171Drug Registration in Philippines
Lecture 172Drug Registration in Singapore
Section 16CDSCO : Drug Registration in India (Optional)
Lecture 173Drug Regulation in India - CDSCO
Lecture 174National Pharmaceutical Pricing Authority
Lecture 175Drug Price Regulation in India
Lecture 176Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 177Drug Price Control Order 2013
Lecture 178Case Study of New Drug Approval in India
Section 17Final Examination
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,