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drug regulatory affairs course




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Drug Regulatory Affairs course provides practical knowledge and hands on training on drug regulation and registration process. This course is online self paced. Hence, one can attend the course 24×7, based on own convenience.

  • Code: KPE-C-003
  • Course Title: Advanced Diploma in Drug Regulatory Affairs (ADDRA)
  • Nature of course: Distance and e-learning; self paced learning

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, EMEA, and other national regulatory agencies, all over the world are imposing number of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease.

  • 24×7 self paced online learning. Hence, you can access the course 24×7 based on your convenience.
  • Pintable 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)
  • Course features real-life case based learning. Therefore, it provides the job related exposures.

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 Deliverable – Regulatory Affairs advanced program

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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 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 | Practical Training in Preparing ICF | Templates
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 37Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 38Regulatory Strategies in different phases of Clinical Trial
Lecture 39Advance study on Para IV Filing
Lecture 40Para IV Notice
Lecture 41Evergreening - Patent Life Extension Strategies
Lecture 42Pay For Delay Strategy
Lecture 43REMS Strategic Planning
Lecture 44Compulsory Licensing
Lecture 45Technology Licensing
Lecture 46In-Licensing Vs. Outlicensing
Lecture 47LOE Strategies for Innovator Brands with case study
Lecture 48Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 49Drug Re-purposing
Lecture 50Practical Queries on different USFDA application and Filing 
Section 5GMP
Lecture 51Definition of GMP
Lecture 52Certification Pharmaceutical Companies / Plants
Lecture 53Premises & Plant Layout Designing
Lecture 54Sanitation and Hygiene
Lecture 55Equipment
Lecture 56Production Modules
Lecture 57GMP Documentation
Lecture 58Quality Control
Lecture 59Handling of Product Complaint
Lecture 60GMP Storage
Lecture 61ISO and ISO Audits
Lecture 62Pharmaceutical SOPs
Lecture 63SOP Automation
Section 6Drug Master File & Site Master File
Lecture 64Key Consideration for Drug Master File Preparation and Submission 
Lecture 65Practical Understanding on Drug Master File Preparation and Submission
Lecture 66Site Master File - Detailed Understanding 
Lecture 67DMF Completeness Assessment
Lecture 68Drug Master File - Fees
Lecture 69Drug Master File - Global Perspective [Across Different Regions]
Section 7Biopharmaceutical Regulation [Innovator & Biosimilar]
Lecture 70Introduction : Biopharmaceuticals
Lecture 71Classification of Biopharmaceutical 
Lecture 72Chemical Drugs Vs. Biologic Drugs
Lecture 73Principle of Naming of Biologics
Lecture 74Current Trends in Biopharmaceutical Market
Lecture 75Present Encouraging Factors for Biopharmaceutical Industry
Lecture 76Complexity of biopharma supply chain and operations
Lecture 77Biopharma Market Segmentation
Lecture 78Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 79Recombinant protein
Lecture 80Monoclonal Antibodies
Lecture 81Synthetic Immunomodulators
Lecture 82Production of Monoclonal Antibodies
Lecture 83Cytokines
Lecture 84Interferon
Lecture 85Erythropoiesis-stimulating agent
Lecture 86Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 87Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 88Vaccine development and approval Process
Lecture 89Purple Book: Significance | Searching | Assignments
Lecture 90Biosimilar Development Process
Lecture 91Strategic Consideration for Biosimilar Development 
Lecture 92Bio-Manufacturing Process Information
Lecture 93Studies required for approval of biosimilar
Section 8Data Integrity and Consequences : Effective Management of Data Integrity Issues
Lecture 94Data Integrity issues in Pharmaceutical Industry
Lecture 95EIR | 483 Observations | Warning Letter | Handling of FDA inspection
Lecture 96Handling of warning letter
Lecture 97Case Study: Warning Letter
Lecture 98CAPA - Importance and principle
Lecture 99Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 9Drug Registration in European Country (Optional)
Lecture 100Introduction to EU Regulation 
Lecture 101Orientation to European Countries and National Regulatory Bodies
Lecture 102EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 103Overview of EU Regulation 
Lecture 104EMA and EMA Authorisation Process
Lecture 105EU MA Application Types and Strategic Planning
Lecture 106EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 107EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 108Validity 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 109Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 110EU Orphan Medicinal Products Regulation
Lecture 111Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 112Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 113Summary of Product Characteristics 
Lecture 114Compassionate Use
Lecture 115MHRA - UK Regulation 
Lecture 116The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 117Accelerated assessment by EMEA
Lecture 118Master Data Maintenance by EMEA
Lecture 119EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 120EU Prime Designation
Lecture 121EU Adaptive Pathway
Lecture 122European public assessment report (EPAR) - Importance, Component, Management, Updation 
Section 10Innovator Drug Registration Dossier and Generic Submission
Lecture 123Introduction to Common Technical Document (CTD)
Lecture 124CMC Dossier & Compliance Management
Lecture 125ECTD
Lecture 126Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 127Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 128Black Box Warning
Lecture 129Importance of effective dossier management
Lecture 130Deficiencies observed in CTD Dossiers
Lecture 131Certificate of Analysis
Lecture 132Detailed Understanding on ANDA Submission Dossier 
Lecture 133Prior Approval Submission 
Lecture 134Detailed Understanding on ANDA Fees
Lecture 135505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 136NCE Vs. 505b2 application - Case Based Learning 
Lecture 137FTF - 180 Days Exclusivity - Case Based Learning
Lecture 138Classic case study of the 505b2 filing
Lecture 139Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 140Asean Common Technical Document (ACTD) 
Lecture 141Discussion on 85 common deficiency in CTD submission dossier
Section 11Portfolio Management and Related Topics
Lecture 142Advance understanding of the portfolio Management
Lecture 143Importance of market research in pharmaceutical industry
Lecture 144Co-promotion & Co-marketing strategy in pharma industry
Lecture 145Concept of Reverse co-promotion in pharma industry
Lecture 146Publication Management from Regulatory perspective
Lecture 147Juxtapid Case Study
Lecture 148New Indication Approval Process and Promotion
Lecture 149OTC Switch
Lecture 150Practical Case Study in Rx to OTC Switch
Section 12API Regulatory Affairs
Section 13Final Examination
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