Section 1Fundamental of Drug Discovery and Development | US Regulatory Affairs
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 6Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studiesÂ
Lecture 7Types and Timing of Non-clinical StudiesÂ
Lecture 8USFDA Expedited Programs (Detailed Understanding)
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Concept of Authorized Generics: Key Understanding
Lecture 11Concept of Exploratory IND
Lecture 12Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 13Orphan Drug Designation
Lecture 14Advance Learning on 505B2 Pathway
Lecture 15Chemistry, Manufacturing & Controls - Fundamental Understanding
Lecture 16Review on Drug Discovery and DevelopmentÂ
Lecture 17Complete Response Letter | Key understanding | Management and Action Plan
Lecture 18Handling of orange book
Lecture 19Review on Drug Discovery and DevelopmentÂ
Lecture 20Understanding on Clinical Trials and Clinical ResearchÂ
Lecture 21Clinical Trial Protocol Writing
Lecture 22Ethics in Clinical Research
Lecture 23Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 24FDA Forms and How to fill the resources
Lecture 25Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 26Preformulation Study in Drug DevelopmentÂ
Lecture 27Regulatory Requirements for Preformulation StudyÂ
Lecture 28Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies Â
Lecture 29Introduction to ICH | Members | GuidelinesÂ
Lecture 30ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 31ICH Q2 : Analytical ValidationÂ
Lecture 32ICH Q3 : Impurities
Lecture 33Rest of ICH Q Family Guidelines
Lecture 34Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | FactsheetsÂ
Lecture 35Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Section 2European Drug Regulatory Affairs
Lecture 36Orientation to European Countries and National Regulatory Bodies
Lecture 37EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 38Overview of EU RegulationÂ
Lecture 39EMA and EMA Authorisation Process
Lecture 40EU MA Application Types and Strategic Planning
Lecture 41EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
Lecture 42EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 43Validity of the EU MAÂ - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 44Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 45EU Orphan Medicinal Products Regulation
Lecture 46EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities &Â Differentiation
Lecture 47Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 48Summary of Product CharacteristicsÂ
Lecture 49Compassionate Use
Lecture 50IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 51Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 52Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 53EU Prime DesignationÂ
Lecture 54Accelerated assessment by EMEA
Lecture 55EU Adaptive Pathway
Lecture 56European public assessment report (EPAR) - Importance, Component, Management, UpdationÂ
Lecture 57SPOR - Concept of Master Data Management Â
Lecture 58MHRA - UK RegulationÂ
Lecture 59The 'sunset clause' for marketing authorisation of pharmaceuticals
Section 3 Regulatory Strategic Management and planning
Lecture 60Regulatory Strategies in different phases of Clinical Trial
Lecture 61Advance study on Para IV Filing
Lecture 62Para IV Notice
Lecture 63Evergreening - Patent Life Extension Strategies
Lecture 64Pay For Delay Strategy
Lecture 65REMS Strategic Planning
Lecture 66Compulsory Licensing
Lecture 67Licensing & Technology Transfer
Lecture 68In-Licensing Vs. Outlicensing
Lecture 69LOE Strategies for Innovator Brands with case study
Lecture 70Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 71Drug Re-purposing
Lecture 72Practical Queries on different USFDA application and Filing
Lecture 73Publication Management from Regulatory perspective
Lecture 74Juxtapid Case Study
Lecture 75New Indication Approval Process and Promotion
Lecture 76OTC Switch
Section 4Good Manufacturing Practices
Lecture 77Certification Pharmaceutical Companies / Plants
Lecture 78Premises & Plant Layout Designing
Lecture 79Sanitation and Hygiene
Lecture 80Equipment
Lecture 81Production Modules
Lecture 82GMP Documentation
Lecture 83Quality Control
Lecture 84Handling of Product Complaint
Lecture 85GMP Storage
Lecture 86ISO and ISO Audits
Lecture 87Pharmaceutical SOPs
Lecture 88SOP Automation
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 89Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 90CMC Dossier & Compliance Management
Lecture 91Electronic Common Technical Document (ECTD)
Lecture 92Advance Practical Training on Dossier Preparation focusing on drug registration in export countriesÂ
Lecture 93Key Consideration for Drug Master File Preparation and SubmissionÂ
Lecture 94Practical Understanding on Drug Master File Preparation and Submission
Lecture 95Site Master File - Detailed UnderstandingÂ
Lecture 96DMF Completeness Assessment
Lecture 97Drug Master File - Fees
Lecture 98Drug Master File - Global Perspective [Across Different Regions]
Lecture 99Importance of effective dossier management
Lecture 100Common deficiencies in CTD submission dossier
Lecture 101Certificate of Analysis
Lecture 102Detailed Understanding on ANDA Fees
Lecture 103Prior Approval SubmissionÂ
Lecture 104Detailed Understanding on ANDA Fees
Lecture 105Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 106NCE Vs. 505b2 application - Case Based LearningÂ
Lecture 107FTF - 180 Days Exclusivity - Case Based Learning
Lecture 108Classic case study of the 505b2 filing : Case Based Learning
Lecture 109Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 110Discussion on 85 common deficiency in CTD submission dossier
Lecture 111Asean Common Technical Document (ACTD)Â
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 112Data Integrity issues in Pharmaceutical Industry
Lecture 113Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning LetterÂ
Lecture 114Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 115RTQs | Response to Queries | How to handle Regulatory Queries Â
Section 7Bioequivalence Study
Lecture 116PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 117Bioequivalence Study | Study design | Different types of BE Studies
Lecture 118Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning | Analyte | Bioanalytical Methods Validation | Statistical Model | Ln Transformation | Dose normalisation | Confidence interval acceptance criteria
Lecture 119Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submissionÂ
Lecture 120Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence studyÂ
Lecture 121Bioequivalence Study - Discussion - Dissolution Testing
Lecture 122Bioequivalence Study - Generic Approval and Additives Labeling RequirementsÂ
Section 8Variation Management
Lecture 123Introduction to Variation Management | Reasons for Variation | Working in Variation DepartmentÂ
Lecture 124Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 9Stability Study
Lecture 125Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 126Climate Zone
Lecture 127Stability Zone Finder
Lecture 128Stability Studies : Case discussions
Lecture 129Stability Data for Zone IV countries
Lecture 130Accelerated and intermediate testing conditions
Lecture 131Long Term Stability Testing Requirements
Lecture 132Stability Study Protocol Development - Dosage form: Capsule
Lecture 133Stability Data Sheet
Lecture 134Dossier Stability Test
Lecture 135Testing Frequency
Lecture 136Bracketing
Lecture 137Matrixing
Section 10Biopharmaceutical Regulatory Affairs (Innovative Biologics and Biosimilars / Similar Biologics)
Lecture 138Introduction to Biopharmaceuticals
Lecture 139Classification of BiopharmaceuticalÂ
Lecture 140Chemical Drugs Vs. Biologic Drugs
Lecture 141Principle of Naming of Biologic | Understanding on MAB naming systemÂ
Lecture 142Global Biologics Market – By Product
Lecture 143Recombinant protein
Lecture 144Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 145Monoclonal Antibodies
Lecture 146Synthetic Immunomodulators
Lecture 147Production of Monoclonal Antibodies
Lecture 148Cytokines
Lecture 149Interferon
Lecture 150Erythropoiesis-stimulating agent
Lecture 151Biological Licensing Application (BLA)Â
Lecture 152Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 153Purple Book: Significance | Searching | Assignments
Lecture 154Vaccine development and approval Process
Lecture 155Biosimilar Development Process
Lecture 156Strategic Consideration for Biosimilar DevelopmentÂ
Lecture 157Bio-Manufacturing Process Information
Lecture 158Studies required for approval of biosimilar