InstructorRoyed Training
TypeOnline Course
Student Enrolled16
Price$790 USD / 39500 INR.
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International drug regulatory affairs course

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Section 1Fundamental of Drug Discovery and Development
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 6Preformulation Study in Drug Development 
Lecture 7Regulatory Requirements for Preformulation Study 
Lecture 8Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies  
Lecture 9Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies 
Lecture 10Types and Timing of Non-clinical Studies 
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 14Review on Drug Discovery and Development 
Lecture 15Understanding on Clinical Trials  and Clinical Research 
Lecture 16Clinical Trial Protocol Writing
Lecture 17Ethics in Clinical Research
Lecture 18Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 19FDA Forms and How to fill the resources
Lecture 20Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 21Chemistry, Manufacturing & Controls 
Lecture 22Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 23505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 24Advance Learning on 505B2 Pathway
Lecture 25Authorized Generics: Key Understanding
Lecture 26USFDA expedited programs
Lecture 27Complete Response Letter | Key understanding | Management and Action Plan
Lecture 28Introduction to ICH | Members | Guidelines 
Lecture 29ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 30ICH Q2 : Analytical Validation 
Lecture 31ICH Q3 : Impurities
Lecture 32Rest of ICH Q Family Guidelines
Lecture 33Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets 
Section 2Innovation Management in Pharmaceutical and Biopharmaceutical Organization
Lecture 34Introduction to intellectual Property Management
Lecture 35Clinical Trial Protocol Writing
Lecture 36Understanding on Patent System
Lecture 37Patent Grant and Managing Patent Filing Procedure
Lecture 38Scope of Patentability 
Lecture 39Patent Grant and Handling Process in India 
Lecture 40Stages of Patent Grant Procedure
Lecture 41Patent search in Indian Patent Office
Lecture 42Differences in US and European Patent
Lecture 43Patent Claim | Types of Patent Claims 
Lecture 44Patent Cliff | How to calculate the patent cliff
Lecture 45Terminologies related to patent, trademark, copyright and licensing 
Lecture 46Patent Infringement
Lecture 47Introduction to Trademark | Trademark filing procedure
Lecture 48Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 49Trademark Infringement | Passing off | Practical Cases
Lecture 50Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3 Regulatory Strategic Management and planning
Lecture 51Regulatory Strategies in different phases of Clinical Trial
Lecture 52Advance study on Para IV Filing
Lecture 53Para IV Notice
Lecture 54Evergreening - Patent Life Extension Strategies
Lecture 55Pay For Delay Strategy
Lecture 56REMS Strategic Planning
Lecture 57Compulsory Licensing
Lecture 58Licensing & Technology Transfer
Lecture 59In-Licensing Vs. Outlicensing
Lecture 60LOE Strategies for Innovator Brands with case study
Lecture 61Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 62Drug Re-purposing
Lecture 63Practical Queries on different USFDA application and Filing
Lecture 64Publication Management from Regulatory perspective
Lecture 65Juxtapid Case Study
Lecture 66New Indication Approval Process and Promotion
Lecture 67OTC Switch
Section 4Good Manufacturing Practices
Lecture 68Certification Pharmaceutical Companies / Plants
Lecture 69Premises & Plant Layout Designing
Lecture 70Sanitation and Hygiene
Lecture 71Equipment
Lecture 72Production Modules
Lecture 73GMP Documentation
Lecture 74Quality Control
Lecture 75Handling of Product Complaint
Lecture 76GMP Storage
Lecture 77ISO and ISO Audits
Lecture 78Pharmaceutical SOPs
Lecture 79SOP Automation
Lecture 80PDE Value | Importance, Significance | How to calculate PDE value 
Lecture 81Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 82Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning 
Lecture 83WHO-GMP Certification Scheme 
Lecture 84Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 85Common Technical Document (CTD)
Lecture 86CMC Dossier & Compliance Management
Lecture 87Electronic Common Technical Document (ECTD)
Lecture 88Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 89Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 90Key Consideration for Drug Master File Preparation and Submission 
Lecture 91Practical Understanding on Drug Master File Preparation and Submission
Lecture 92Site Master File - Detailed Understanding 
Lecture 93DMF Completeness Assessment
Lecture 94Drug Master File - Fees
Lecture 95Drug Master File - Global Perspective [Across Different Regions]
Lecture 96Importance of effective dossier management
Lecture 97Common deficiencies in CTD submission dossier
Lecture 98Certificate of Analysis
Lecture 99Detailed Understanding on ANDA Fees
Lecture 100Prior Approval Submission 
Lecture 101Detailed Understanding on ANDA Fees
Lecture 102Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 103NCE Vs. 505b2 application - Case Based Learning 
Lecture 104FTF - 180 Days Exclusivity - Case Based Learning
Lecture 105Classic case study of the 505b2 filing : Case Based Learning
Lecture 106Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 107Climate Zone and Stability Study Conditions as per ICH Guidelines 
Lecture 108Stability Zone Finder
Lecture 109Stability Studies : Case discussions
Lecture 110Case Study: Managing Stability Study for Zone IV countries
Lecture 111Accelerated and intermediate testing conditions
Lecture 112Long Term Stability Testing Requirements
Lecture 113Testing Frequency
Lecture 114Bracketing
Lecture 115Matrixing
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 submission 
Lecture 120Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 121Bioequivalence Study - Discussion - Dissolution Testing
Lecture 122Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 123Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 124Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Lecture 125Setting Dissolution Specification for Generic Products | Regulatory Expectations
Lecture 126Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 127Data Integrity issues in Pharmaceutical Industry
Lecture 128Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 129Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 130RTQs | Response to Queries | How to handle Regulatory Queries  
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 131Introduction of Biologics
Lecture 132Classification of Biopharmaceutical 
Lecture 133Chemical Drugs Vs. Biologic Drugs
Lecture 134Principle of Naming of Biologics
Lecture 135Global Biologics Market – By Product | By Therapeutic Class | By Region
Lecture 136Recombinant protein
Lecture 137Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 138Monoclonal Antibodies
Lecture 139Synthetic Immunomodulators
Lecture 140Production of Monoclonal Antibodies
Lecture 141Cytokines
Lecture 142Interferon
Lecture 143Erythropoiesis-stimulating agent
Lecture 144Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 145Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 146Purple Book: Significance | Searching | Assignments
Lecture 147Vaccine development and approval Process
Lecture 148PDUFA For Biologics
Lecture 149Biosimilar Development Process
Lecture 150Strategic Consideration for Biosimilar Development 
Lecture 151Bio-Manufacturing Process Information
Lecture 152Studies required for approval of biosimilar
Lecture 153Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 154Comparability of Biologics | Different Categories of Comparability | General Principles 
Lecture 155CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Lecture 156ATMPs | Types and Classification | Regulatory Mechanism 
Section 8European Drug Regulatory Affairs
Lecture 157Introduction to EU Regulation 
Lecture 158Orientation to European Countries and National Regulatory Bodies
Lecture 159EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 160Overview of EU Regulation 
Lecture 161EMA and EMA Authorisation Process
Lecture 162EU MA Application Types and Strategic Planning
Lecture 163EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 164EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 165Validity 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 166Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 167EU Orphan Medicinal Products Regulation
Lecture 168Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 169Summary of Product Characteristics 
Lecture 170Compassionate Use
Lecture 171IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 172Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 173Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 174EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 175EU Prime Designation 
Lecture 176Accelerated assessment by EMEA
Lecture 177EU Adaptive Pathway
Lecture 178European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 179SPOR  - Concept of Master Data Management  
Lecture 180PDE Value : What is PDE value of API? Significance and How PDE value is derived? 
Lecture 181MHRA - UK Regulation 
Lecture 182The 'sunset clause' for marketing authorisation of pharmaceuticals
Section 9ASEAN Drug Regulatory Affairs
Lecture 183Introduction to ASEAN - Drug Regulatory Affairs 
Lecture 184ASEAN Countries | Introduction | Geographical Overview 
Lecture 185ASEAN countries drug regulatory bodies
Lecture 186ASEAN Common Technical Requirements (ACTRs)
Lecture 187The Pharmaceutical Inspection Co-operation Scheme
Lecture 188CPP Requirements for Drug Registration in ASEAN countries
Lecture 189Dossier Requirements - ACTD/CTD Acceptability
Lecture 190Pharmacopoeias Acceptability
Lecture 191Harmonization of Technical Guidelines 
Lecture 192Stability Study requirements for drug registration in ASEAN countries
Lecture 193Guideline on product labelling
Lecture 194Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 195Pharmacovigilance and Risk Management Plan (RMP)
Lecture 196Timeline of Drug Registration Approval
Lecture 197ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 198Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 199Drug Registration and Regulation in Brunei
Lecture 200Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 201African Continent Overview - Brief introduction to course
Lecture 202African Pharma Market
Lecture 203Drug Registration - African medicines regulatory agencies
Lecture 204Basic Export Requirement for African Countries
Lecture 205Export Documentations & Important Concepts
Lecture 206Drug Registration and Regulation in Nigeria
Lecture 207Drug Registration in Algeria
Lecture 208Drug Registration in Ethiopia
Lecture 209Drug Registration in Kenya
Lecture 210Drug Registration in Egypt
Lecture 211Drug Registration in Ghana
Lecture 212Drug Registration in Botswana
Lecture 213Drug Registration and Regulation in Uganda
Lecture 214Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 215Introduction to Latam 
Lecture 216Drug Registration and Regulation in Argentina 
Lecture 217Drug Registration and Regulation in Bolivia
Lecture 218Drug Registration and Regulation in Brazil 
Lecture 219Drug Registration and Regulation in CHILE
Lecture 220Drug Registration and Regulation in Colombia
Lecture 221Drug Registration and Regulation in Mexico
Lecture 222Drug regulation and registration in El Salvador
Lecture 223Central America Drug Regulatory Affairs | Panama, Costa Rica, Guatemala, El Salvador, Honduras, Dominican Republic | RTCA guideline [2022]
Section 12Middle East and GCC Drug Regulatory Affairs
Lecture 224Middle East / MENA / GCC Countries Geographical Orientation 
Lecture 225Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 226GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 227Drug Registration in Saudi Arabia
Lecture 228Drug Registration in UAE
Lecture 229Drug Registration and Regulatory Strategic Planning for Iran
Lecture 230Drug Registration and Regulatory Strategic Planning for Israel
Lecture 231Drug Registration and Regulatory Strategic Planning for Jordan
Lecture 232Drug Registration and Regulatory Strategic Planning for Iraq
Section 13China Drug Regulatory Affairs
Lecture 233Drug Registration and Regulation in China
Lecture 234China NMPA New Regulation Update July, 2020
Section 14Russia - EAEU Regulatory Affairs
Lecture 235Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 236GMP requirements in Russia
Section 15References | Discussions
Lecture 237Comparison of Requirement of Various Regulatory Bodies
Lecture 238Comparison of Dossier Requirements of Europe and US
Lecture 239Comparison of DMF requirement of various regulatory bodies
Section 16Japan Drug Regulation and Registration Process
Lecture 240Introduction to Japan Drug Regulatory Affairs 
Lecture 241Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval 
Lecture 242Drug Approval System | GCP | PMDA requirements 
Lecture 243New Drug Application | Requirements | Review Process
Lecture 244Generic Drug Application Review and Approval 
Lecture 245Marketing Authorization Process for registration of pharmaceutical in Japan
Lecture 246API Registration in Japan | Step By Step Process
Lecture 247Generic Registration | Patent - Patent Term Extension | Exclusivity | Re-examination System | Pediatric Designation |  Patent Term Extension Case Studies
Lecture 248Priority Review Application | Criteria | Review Process | Timeline
Lecture 249Orphan Drug Designation in Japan
Lecture 250Japan DMF System | MF filing Process | Key points 
Lecture 251Strategic Approval Pathway - Formulation Approval Quoting MF
Lecture 252SAKIGAKE designation 
Section 17Drug Registration and Regulation in India
Lecture 253Drug Registration and Regulation in India - Prime Session | CDSCO - Organization Regulatory Functions - Central and State | Import License | Registration Certificate | Inspection, Fees and Process | Export from India | Step by Step Guidance
Lecture 254Medicine Export Criteria from India
Lecture 255Documents for conducting BE Study for Export
Lecture 256New Drug Approval in DCGI
Lecture 257Line Extension New Strength Approval