InstructorRoyed Training
TypeOnline Course
Student Enrolled29
Price$690 USD
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This course is designed exclusively with objective to impart Induction Training for Regulatory Affairs.

Maximum Access Duration: 1st of August, 2022 to 31st of March, 2023

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