InstructorRoyed Training
TypeOnline Course
Student Enrolled37
Price$690 USD
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This course is designed exclusively with objective to impart Induction Training for Regulatory Affairs.

Core Learning Areas

  • Drug Development Process and Product Development – Drug Discovery to commercialization.
  • GMP and related topics of Production Management
  • Dossier, CMC, Drug Master Files and Regulatory Assessment Activities
  • Post DRA activities
  • Regulatory Affairs Strategic Planning
  • Biologic Regulatory Affairs
  • EU Regulatory Affairs
  • GCC Regulatory Affairs
  • Middle East and GCC Drug Registration
  • African Regulatory Affairs
  • ASEAN Regulatory Affairs
  • Latam Regulatory Affairs
  • China Regulatory Affairs
  • Japan Regulatory Affairs
  • RTQs
  • Advance GMP Topics

Methodology: Login with your user id and password and access the course step by step.

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Corporate Training: Specialized designed for the employees of SynerG Biopharma.

Usage Restricted to SynerG Biopharma Employees Only !

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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 [**Optional]
Lecture 34Introduction to intellectual Property Management [**Optional]
Lecture 35Introduction to Patent [**Optional]
Lecture 36Understanding on Patent System [**Optional]
Lecture 37Patent Grant and Managing Patent Filing Procedure [**Optional]
Lecture 38Scope of Patentability [**Optional]
Lecture 39Patent Grant and Handling Process in India  [**Optional]
Lecture 40Stages of Patent Grant Procedure [**Optional]
Lecture 41Patent search in Indian Patent Office [**Optional]
Lecture 42Differences in US and European Patent [**Optional]
Lecture 43Patent Claim | Types of Patent Claims [**Optional]
Lecture 44Patent Cliff | How to calculate the patent cliff [**Optional]
Lecture 45Terminologies related to patent, trademark, copyright and licensing [**Optional]
Lecture 46Patent Infringement [**Optional]
Lecture 47Introduction to Trademark | Trademark filing procedure [**Optional]
Lecture 48Trademark Searching Process | EUIPO Searching | USPTO Searching [**Optional] | IPINDIA Searching 
Lecture 49Trademark Infringement | Passing off | Practical Cases [**Optional]
Lecture 50Trademark Classes | How to search the right trademark class for for filing trademark application [**Optional]
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 [**Optional]
Lecture 55Pay For Delay Strategy [**Optional]
Lecture 56REMS Strategic Planning [**Optional]
Lecture 57Compulsory Licensing
Lecture 58Licensing & Technology Transfer
Lecture 59In-Licensing Vs. Outlicensing [**Optional]
Lecture 60LOE Strategies for Innovator Brands with case study [**Optional]
Lecture 61Paediatric Exclusivity and Paediatric Study Plan Development [**Optional]
Lecture 62Drug Re-purposing
Lecture 63Practical Queries on different USFDA application and Filing
Lecture 64New Indication Approval Process and Promotion
Lecture 65OTC Switch
Section 4Good Manufacturing Practices
Lecture 66Certification Pharmaceutical Companies / Plants
Lecture 67Premises & Plant Layout Designing
Lecture 68Sanitation and Hygiene
Lecture 69Equipment
Lecture 70Production Modules
Lecture 71GMP Documentation
Lecture 72Quality Control
Lecture 73Handling of Product Complaint
Lecture 74GMP Storage
Lecture 75ISO and ISO Audits
Lecture 76Pharmaceutical SOPs
Lecture 77PDE Value | Importance, Significance | How to calculate PDE value 
Lecture 78Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 79Introduction 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 80WHO-GMP Certification Scheme 
Lecture 81Template 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 82Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 83CMC Dossier & Compliance Management
Lecture 84Electronic Common Technical Document (ECTD)
Lecture 85Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 86Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 87Key Consideration for Drug Master File Preparation and Submission 
Lecture 88Practical Understanding on Drug Master File Preparation and Submission
Lecture 89Site Master File - Detailed Understanding 
Lecture 90DMF Completeness Assessment
Lecture 91Drug Master File - Fees [**Optional]
Lecture 92Drug Master File - Global Perspective [Across Different Regions]
Lecture 93Importance of effective dossier management
Lecture 94Common deficiencies in CTD submission dossier
Lecture 95Certificate of Analysis
Lecture 96Detailed Understanding on ANDA Submission Dossier 
Lecture 97Prior Approval Submission 
Lecture 98Detailed Understanding on ANDA Fees [**Optional]
Lecture 99Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 100NCE Vs. 505b2 application - Case Based Learning 
Lecture 101FTF - 180 Days Exclusivity - Case Based Learning
Lecture 102Classic case study of the 505b2 filing : Case Based Learning
Lecture 103Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 104Climate Zone and Stability Study Conditions as per ICH Guidelines 
Lecture 105Stability Zone Finder
Lecture 106Stability Studies : Case discussions
Lecture 107Stability Data for Zone IV countries
Lecture 108Accelerated and intermediate testing conditions
Lecture 109Long Term Stability Testing Requirements
Lecture 110Testing Frequency
Lecture 111Bracketing
Lecture 112Matrixing
Lecture 113PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 114Bioequivalence Study | Study design | Different types of BE Studies
Lecture 115Bioequivalence 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 116Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 117Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 118Bioequivalence Study - Discussion - Dissolution Testing
Lecture 119Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 120Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 121Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 122Data Integrity issues in Pharmaceutical Industry
Lecture 123Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 124Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 125RTQs | Response to Queries | How to handle Regulatory Queries  
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 126Introduction of Biologics
Lecture 127Classification of Biopharmaceutical 
Lecture 128Chemical Drugs Vs. Biologic Drugs
Lecture 129Principle of Naming of Biologics
Lecture 130Global Biologics Market – By Product
Lecture 131Recombinant protein
Lecture 132Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 133Monoclonal Antibodies
Lecture 134Synthetic Immunomodulators
Lecture 135Production of Monoclonal Antibodies
Lecture 136Cytokines
Lecture 137Interferon
Lecture 138Erythropoiesis-stimulating agent
Lecture 139Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 140Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 141Purple Book: Significance | Searching | Assignments
Lecture 142Vaccine development and approval Process
Lecture 143PDUFA For Biologics
Lecture 144Biosimilar Development Process
Lecture 145Strategic Consideration for Biosimilar Development 
Lecture 146Bio-Manufacturing Process Information
Lecture 147Studies required for approval of biosimilar
Section 8European Drug Regulatory Affairs
Lecture 148Introduction to EU Regulation 
Lecture 149Orientation to European Countries and National Regulatory Bodies
Lecture 150EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 151Overview of EU Regulation 
Lecture 152EMA and EMA Authorisation Process
Lecture 153EU MA Application Types and Strategic Planning
Lecture 154EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 155EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 156Validity 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 157Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 158EU Orphan Medicinal Products Regulation
Lecture 159Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 160Summary of Product Characteristics 
Lecture 161Compassionate Use
Lecture 162IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 163Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 164Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 165EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 166EU Prime Designation 
Lecture 167Accelerated assessment by EMEA
Lecture 168EU Adaptive Pathway
Lecture 169European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 170SPOR  - Concept of Master Data Management  [**Optional]
Lecture 171PDE Value : What is PDE value of API? Significance and How PDE value is derived? 
Lecture 172MHRA - UK Regulation 
Lecture 173The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 174Post approval change control management | Scenarios and Cases 
Section 9ASEAN Drug Regulatory Affairs
Lecture 175Introduction to ASEAN - Drug Regulatory Affairs 
Lecture 176ASEAN Countries | Introduction | Geographical Overview 
Lecture 177ASEAN countries drug regulatory bodies
Lecture 178ASEAN Common Technical Requirements (ACTRs)
Lecture 179The Pharmaceutical Inspection Co-operation Scheme
Lecture 180CPP Requirements for Drug Registration in ASEAN countries
Lecture 181Dossier Requirements - ACTD/CTD Acceptability
Lecture 182Pharmacopoeias Acceptability
Lecture 183Harmonization of Technical Guidelines 
Lecture 184Stability Study requirements for drug registration in ASEAN countries
Lecture 185Guideline on product labelling
Lecture 186Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 187Pharmacovigilance and Risk Management Plan (RMP)
Lecture 188Timeline of Drug Registration Approval
Lecture 189ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 190Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 191Drug Registration and Regulation in Brunei [**Optional]
Lecture 192Drug Registration and Regulation in Cambodia [**Optional]
Section 10African Drug Regulatory Affairs
Lecture 193African Continent Overview - Brief introduction to course
Lecture 194African Pharma Market
Lecture 195Drug Registration - African medicines regulatory agencies
Lecture 196Basic Export Requirement for African Countries
Lecture 197Export Documentations & Important Concepts
Lecture 198Drug Registration and Regulation in Nigeria
Lecture 199Drug Registration in Algeria
Lecture 200Drug Registration in Ethiopia
Lecture 201Drug Registration in Kenya
Lecture 202Drug Registration in Egypt
Lecture 203Drug Registration in Ghana
Lecture 204Drug Registration in Botswana
Lecture 205Drug Registration and Regulation in Uganda
Lecture 206Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 207Introduction to Latam 
Lecture 208Drug Registration and Regulation in Argentina 
Lecture 209Drug Registration and Regulation in Bolivia
Lecture 210Drug Registration and Regulation in Brazil 
Lecture 211Drug Registration and Regulation in CHILE
Lecture 212Drug Registration and Regulation in Colombia
Lecture 213Drug Registration and Regulation in Mexico
Lecture 214Drug regulation and registration in El Salvador
Lecture 215Central America Drug Regulatory Affairs | Panama, Costa Rica, Guatemala, El Salvador, Honduras, Dominican Republic | RTCA guideline [2022]
Section 12GCC Drug Regulatory Affairs
Lecture 216Introduction: GCC Pharmaceutical Market
Lecture 217GCC Registration Procedure - Centralized and Decentralized Procedure 
Lecture 218Drug Registration in Saudi Arabia
Lecture 219Drug Registration in UAE
Lecture 220Drug Registration in Kuwait
Lecture 221Drug Registration in Bahrain
Lecture 222Drug Registration in Oman
Lecture 223Documentation Required for the GCC countries 
Section 13China Drug Regulatory Affairs
Lecture 224Drug Registration and Regulation in China
Lecture 225China NMPA New Regulation Update July, 2020
Section 14Russia & EAEU Regulatory Affairs
Lecture 226Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 227GMP requirements in Russia 
Section 15References | Discussions
Lecture 228Comparison of Requirement of Various Regulatory Bodies
Lecture 229Comparison of Dossier Requirements of Europe and US
Lecture 230Comparison of DMF requirement of various regulatory bodies
Section 16Japan Drug Regulatory Affairs
Lecture 231Introduction to Japan Drug Regulatory Affairs 
Lecture 232Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval 
Lecture 233Drug Approval System | GCP | PMDA requirements 
Lecture 234New Drug Application | Requirements | Review Process
Lecture 235Generic Drug Application Review and Approval