International Drug Regulatory Affairs

InstructorRoyed Training

TypeOnline Course

Student Enrolled12

(1 ratings)

Price$750 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 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

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 62Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)

Lecture 63Practical Queries on different USFDA application and Filing

Lecture 64Drug Repurposing

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

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 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 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 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 12Middle East and GCC Drug Regulatory Affairs

Lecture 216Middle East / MENA / GCC Countries Geographical Orientation

Lecture 217Middle East / MENA / GCC Countries National Regulatory Agencies

Lecture 218GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process

Lecture 219Drug Registration in Saudi Arabia

Lecture 220Drug Registration in UAE

Lecture 221Drug Registration and Regulatory Strategic Planning for Iran

Lecture 222Drug Registration and Regulatory Strategic Planning for Israel

Lecture 223Documentation Required for the GCC countries

Lecture 224Drug Registration and Regulatory Strategic Planning for Iraq

Section 13China Drug Regulatory Affairs

Lecture 225Drug Registration and Regulation in China

Lecture 226China NMPA New Regulation Update July, 2020

Section 14Russia & EAEU Regulatory Affairs

Lecture 227Drug Registration and Submission Strategic Planning for Russia and EAEU region

Lecture 228GMP requirements in Russia

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

Lecture 235New Drug Application | Requirements | Review Process

Lecture 236Generic Drug Application Review and Approval

International Drug Regulatory Affairs

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