International Drug Regulatory Affairs

Introduction

Nature of course

Course Duration

Eligibility

Certification

Features

Related Courses

This international drug biologic regulatory affairs course provides understanding of regulation, registration process and strategic planning. This Executive PG Certification in International Drug Regulatory Affairs train regulatory professionals for pharmaceutical and biopharmaceutical industry. This comprehensive drug biologic regulatory affairs training involves the real life job simulation. Hence, the course provides practical knowledge. Moreover, this course focuses on how regulatory professionals work in the company. Therefore, it helps users to understand the key responsibilities and job functions.

This course is ideal for executives working professionals. At the same time, we also have well designed PG certification in Drug Regulatory Affairs course which is ideal for the freshers.

In these online self-paced modules, participants understands about the development to commercialization process in detail. In other words, you will understand stages of drugs, biologics discovery, development, investigational application, marketing authorization application, handling of different phases of clinical trial, generic approval process, Abbreviated drugs approval process. Hence, the course covers fundamentals to advance learning on drugs, biologics development, regulation, registration and strategic management processes.

Most importantly, international drug regulatory affairs course covers comprehensive training all regulatory regions like US, EU, GCC, MENA, Middle East, CIS, African, ASEAN, Japan, Russia, China, India and Rest of the World in a single comprehensive training.

Who should attend this course?

Those who are in the regulatory affairs and related department.
Professionals from drugs, biologics industry.
Anyone requiring an overview and detail understanding on working of regulatory affairs.
Fresher or beginners, Those who want to make a career in the regulatory department.

Course Code: RYD-092

Title: Executive PG Certification in International Drug Regulatory Affairs (EPGIDRA)

Online distance learning course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.

1 Year

Any body who wants to acquire drug regulatory affairs competency should attend the course.

Certificate will be provided at the end of the successful completion of the course

Features of International Drug Regulatory Affairs

This course covers all aspects of the drug, biologics regulatory affairs in a single course. Hence, user need not to purchase the drugs, and biologics training separately.
International Drug Regulatory Affairs course covers both formulation and API regulatory affairs. Hence, the user need not to purchase both the course separately.
EPGIDRA course covers advanced training how to work onmarketing authorization pre-submission, submission, post submission stage.
And most important key feature of the course is “all inclusive marketing authorization submission training”. Hence course covers US, EU, LATAM, Middle East, GCC, ASEAN, Japan, China, India, AU-NZ, ROW regulation. Therefore no need to go for the separate course.
Above all EPGIDRA course covers hands on training on Dossier Submission Training, CTD, ECTD, DMF, SMF, Variation filing. Moreover exclusive training is provided on CMC section writing, which today is must have skill for any regulatory professionals.
Hence this course provides orientation to job related practical aspects of the regulatory managers. Therefore, on completion of the course, the participants will develop the hands on understanding on the regulatory affairs working.
One of the important feature of the course is real life simulation on critical decision making process. Hence, these simulations help to enhance the regulatory strategic decision making.

Case Based Learning

Advance training on drug registration requirements for various regulatory bodies.
Access to Case Studies to learn about the drug registration steps. Hence, participants will develop advanced competency on drugs, biologics strategic planning.

We also have drug, biologic regulatory affairs with medical devices training under same course. Hence, you can learn drug biologic and medical device in a single comprehensive course. Title of the course is Executive PG Certification in Drug Biologic Medical Devices Regulatory Affairs. Click here to view the course details.

Few of the similar courses

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

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

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 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

Section 6Quality issues, Warning Letter, CAPA and Data Integrity

Lecture 125Data Integrity issues in Pharmaceutical Industry

Lecture 126Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter

Lecture 127Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity

Lecture 128RTQs | Response to Queries | How to handle Regulatory Queries

Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations

Lecture 129Introduction of Biologics

Lecture 130Classification of Biopharmaceutical

Lecture 131Chemical Drugs Vs. Biologic Drugs

Lecture 132Principle of Naming of Biologics

Lecture 133Global Biologics Market – By Product

Lecture 134Recombinant protein

Lecture 135Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 136Monoclonal Antibodies

Lecture 137Synthetic Immunomodulators

Lecture 138Production of Monoclonal Antibodies

Lecture 139Cytokines

Lecture 140Interferon

Lecture 141Erythropoiesis-stimulating agent

Lecture 143Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements

Lecture 144Purple Book: Significance | Searching | Assignments

Lecture 145Vaccine development and approval Process

Lecture 146PDUFA For Biologics

Lecture 147Biosimilar Development Process

Lecture 148Strategic Consideration for Biosimilar Development

Lecture 149Bio-Manufacturing Process Information

Lecture 150Studies required for approval of biosimilar

Lecture 152Comparability of Biologics | Different Categories of Comparability | General Principles

Lecture 153CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)

Section 8European Drug Regulatory Affairs

Lecture 154Introduction to EU Regulation

Lecture 155Orientation to European Countries and National Regulatory Bodies

Lecture 156EU Drug Discovery Development to Commercialization (Step By Step)

Lecture 157Overview of EU Regulation

Lecture 158EMA and EMA Authorisation Process

Lecture 159EU MA Application Types and Strategic Planning

Lecture 160EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure

Lecture 161EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application

Lecture 162Validity 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 163Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae

Lecture 164EU Orphan Medicinal Products Regulation

Lecture 165Conditional marketing authorisation | Marketing authorisation under exceptional circumstances

Lecture 166Summary of Product Characteristics

Lecture 167Compassionate Use

Lecture 168IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND

Lecture 169Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB

Lecture 170Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)

Lecture 171EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation

Lecture 172EU Prime Designation

Lecture 173Accelerated assessment by EMEA

Lecture 174EU Adaptive Pathway

Lecture 175European public assessment report (EPAR) - Importance, Component, Management, Updation

Lecture 176SPOR - Concept of Master Data Management

Lecture 177PDE Value : What is PDE value of API? Significance and How PDE value is derived?

Lecture 178MHRA - UK Regulation

Lecture 179The 'sunset clause' for marketing authorisation of pharmaceuticals

Section 9ASEAN Drug Regulatory Affairs

Lecture 180Introduction to ASEAN - Drug Regulatory Affairs

Lecture 181ASEAN Countries | Introduction | Geographical Overview

Lecture 182ASEAN countries drug regulatory bodies

Lecture 183ASEAN Common Technical Requirements (ACTRs)

Lecture 184The Pharmaceutical Inspection Co-operation Scheme

Lecture 185CPP Requirements for Drug Registration in ASEAN countries

Lecture 186Dossier Requirements - ACTD/CTD Acceptability

Lecture 187Pharmacopoeias Acceptability

Lecture 188Harmonization of Technical Guidelines

Lecture 189Stability Study requirements for drug registration in ASEAN countries

Lecture 190Guideline on product labelling

Lecture 191Post Approval Changes (Variations) requirements in ASEAN countries

Lecture 192Pharmacovigilance and Risk Management Plan (RMP)

Lecture 193Timeline of Drug Registration Approval

Lecture 195Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management

Lecture 196Drug Registration and Regulation in Brunei

Lecture 197Drug Registration and Regulation in Cambodia

Section 10African Drug Regulatory Affairs

Lecture 198African Continent Overview - Brief introduction to course

Lecture 199African Pharma Market

Lecture 200Drug Registration - African medicines regulatory agencies

Lecture 201Basic Export Requirement for African Countries

Lecture 202Export Documentations & Important Concepts

Lecture 203Drug Registration and Regulation in Nigeria

Lecture 204Drug Registration in Algeria

Lecture 205Drug Registration in Ethiopia

Lecture 206Drug Registration in Kenya

Lecture 207Drug Registration in Egypt

Lecture 208Drug Registration in Ghana

Lecture 209Drug Registration in Botswana

Lecture 210Drug Registration and Regulation in Uganda

Lecture 211Drug Registration in Zambia

Section 11Latam Regulatory Affairs

Lecture 212Introduction to Latam

Lecture 213Drug Registration and Regulation in Argentina

Lecture 214Drug Registration and Regulation in Bolivia

Lecture 215Drug Registration and Regulation in Brazil

Lecture 216Drug Registration and Regulation in CHILE

Lecture 217Drug Registration and Regulation in Colombia

Lecture 218Drug Registration and Regulation in Mexico

Lecture 219Drug regulation and registration in El Salvador

Lecture 220Central 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 221Middle East / MENA / GCC Countries Geographical Orientation

Lecture 222Middle East / MENA / GCC Countries National Regulatory Agencies

Lecture 223GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process

Lecture 224Drug Registration in Saudi Arabia

Lecture 225Drug Registration in UAE

Lecture 226Drug Registration and Regulatory Strategic Planning for Iran

Lecture 227Drug Registration and Regulatory Strategic Planning for Israel

Lecture 228Drug Registration and Regulatory Strategic Planning for Jordan

Lecture 229Drug Registration and Regulatory Strategic Planning for Iraq

Section 13China Drug Regulatory Affairs

Lecture 230Drug Registration and Regulation in China

Lecture 231China NMPA New Regulation Update July, 2020

Section 14Russia - EAEU Regulatory Affairs

Lecture 232Drug Registration and Submission Strategic Planning for Russia and EAEU region

Lecture 233GMP requirements in Russia

Section 15References | Discussions

Lecture 234Comparison of Requirement of Various Regulatory Bodies

Lecture 235Comparison of Dossier Requirements of Europe and US

Lecture 236Comparison of DMF requirement of various regulatory bodies

Section 16Japan Drug Regulation and Registration Process

Lecture 237Introduction to Japan Drug Regulatory Affairs

Lecture 238Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval

Lecture 239Drug Approval System | GCP | PMDA requirements

Lecture 240New Drug Application | Requirements | Review Process

Lecture 241Generic Drug Application Review and Approval

Section 17Drug Registration and Regulation in India

Lecture 243Medicine Export Criteria from India

Lecture 244Documents for conducting BE Study for Export

Lecture 245New Drug Approval in DCGI

Lecture 246Line Extension New Strength Approval

International Drug Regulatory Affairs

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Introduction

Nature of course

Course Duration

Eligibility

Certification

Features

Related Courses

Who should attend this course?

Features of International Drug Regulatory Affairs

Case Based Learning

Few of the similar courses

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Introduction

Nature of course

Course Duration

Eligibility

Certification

Features

Related Courses

Who should attend this course?

Features of International Drug Regulatory Affairs

Case Based Learning

Few of the similar courses