InstructorRoyed Training
TypeOnline Course
Student Enrolled8
Price$750 USD / 37500 INR.
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international drug regulatory affairs

Introduction

Nature of course

Course Duration

Eligibility

Certification

Features

Related Courses

RA Course comparison

Regulatory Course Comparison

Add on Certification

This online drugs biologics regulatory affairs course provides understanding of regulation, registration process and strategic planning. This PG Certification trains Regulatory Affairs professionals for pharmaceutical and biopharmaceutical industry.

This comprehensive drugs biologics 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.

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

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.
  • The 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

Comparison of Regulatory Affairs Courses [www.royed.in]


Course Coverage

Executive PG Certification in
International Drug Regulatory Affairs

Executive PG Certification in
Drug, Biologic, Medical Devices Regulatory Affairs

PG Certification in Drug
Regulatory Affairs

Drug Regulatory Affairs

YES

YES

YES

Medical Devices Regulatory
Affairs

NO

YES

NO

Biopharmaceutical Regulatory
Affairs

YES

YES

YES

Regional
Regulatory Affairs

US

YES

YES

Yes

EU

YES

YES

YES

GCC

YES

YES

NO

Middle East

YES

YES

NO

Japan

YES

YES

NO

China

YES

YES

NO

ASEAN

YES

YES

NO

Africa

YES

YES

NO

Russia

YES

YES

NO

LATAM

YES

YES

NO

Other – ROW

YES

YES

NO

Free
and Add on Courses

Free Add on course

1 month certificate course, 1
week certificate course

1 month certificate course, 1
week certificate course

NONE

Regulatory Affairs Course Comparison


Course Coverage

Executive PG Certification in International Drug Regulatory Affairs

Executive Program in Drug Biologic Medical Devices Regulatory Affairs

PG Certification in Drug Regulatory Affairs

Drug Regulatory Affairs

YES

YES

YES

Medical Devices Regulatory Affairs

NO

YES

NO

Biopharmaceutical Regulatory Affairs

YES

YES

YES

Regional Regulatory Affairs

US

YES

YES

Yes

EU

YES

YES

YES

GCC

YES

YES

NO

Middle East

YES

YES

NO

Japan

YES

YES

NO

China

YES

YES

NO

ASEAN

YES

YES

NO

Africa

YES

YES

NO

Russia

YES

YES

NO

LATAM

YES

YES

NO

Other – ROW

YES

YES

NO

Free and Add on Courses

Free Add on course

1 month certificate course, 1 week certificate course

1 month certificate course, 1 week certificate course

NONE
  • The participants will get two add on certification.
  • Participant can choose add on courses of any 1 month or 1 week / 3 Days certification course. One can choose the desire course from following course list
  • Participant can activate the add on course anytime during 1 year active course duration.
  • On completion of add on course, participant will be issuing course certificate.
  • You can activate this add on course anytime during the active 1 year course tenure.

 

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 85Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
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
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 Bilogics
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 142Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
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
Section 8European Drug Regulatory Affairs
Lecture 151Introduction to EU Regulation 
Lecture 152Orientation to European Countries and National Regulatory Bodies
Lecture 153EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 154Overview of EU Regulation 
Lecture 155EMA and EMA Authorisation Process
Lecture 156EU MA Application Types and Strategic Planning
Lecture 157EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 158EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 159Validity 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 160Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 161EU Orphan Medicinal Products Regulation
Lecture 162Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 163Summary of Product Characteristics 
Lecture 164Compassionate Use
Lecture 165IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 166Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 167Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 168EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 169EU Prime Designation 
Lecture 170Accelerated assessment by EMEA
Lecture 171EU Adaptive Pathway
Lecture 172European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 173SPOR  - Concept of Master Data Management  
Lecture 174PDE Value : What is PDE value of API? Significance and How PDE value is derived? 
Lecture 175MHRA - UK Regulation 
Lecture 176The 'sunset clause' for marketing authorisation of pharmaceuticals
Section 9ASEAN Drug Regulatory Affairs
Lecture 177Introduction to ASEAN - Drug Regulatory Affairs 
Lecture 178ASEAN Countries | Introduction | Geographical Overview 
Lecture 179ASEAN countries drug regulatory bodies
Lecture 180ASEAN Common Technical Requirements (ACTRs)
Lecture 181The Pharmaceutical Inspection Co-operation Scheme
Lecture 182CPP Requirements for Drug Registration in ASEAN countries
Lecture 183Dossier Requirements - ACTD/CTD Acceptability
Lecture 184Pharmacopoeias Acceptability
Lecture 185Harmonization of Technical Guidelines 
Lecture 186Stability Study requirements for drug registration in ASEAN countries
Lecture 187Guideline on product labelling
Lecture 188Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 189Pharmacovigilance and Risk Management Plan (RMP)
Lecture 190Timeline of Drug Registration Approval
Lecture 191ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 192Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 193Drug Registration and Regulation in Brunei
Lecture 194Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 195African Continent Overview - Brief introduction to course
Lecture 196African Pharma Market
Lecture 197Drug Registration - African medicines regulatory agencies
Lecture 198Basic Export Requirement for African Countries
Lecture 199Export Documentations & Important Concepts
Lecture 200Drug Registration and Regulation in Nigeria
Lecture 201Drug Registration in Algeria
Lecture 202Drug Registration in Ethiopia
Lecture 203Drug Registration in Kenya
Lecture 204Drug Registration in Egypt
Lecture 205Drug Registration in Ghana
Lecture 206Drug Registration in Botswana
Lecture 207Drug Registration and Regulation in Uganda
Lecture 208Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 209Introduction to Latam 
Lecture 210Drug Registration and Regulation in Argentina 
Lecture 211Drug Registration and Regulation in Bolivia
Lecture 212Drug Registration and Regulation in Brazil 
Lecture 213Drug Registration and Regulation in CHILE
Lecture 214Drug Registration and Regulation in Colombia
Lecture 215Drug Registration and Regulation in Mexico
Lecture 216Drug regulation and registration in El Salvador
Section 12GCC Drug Regulatory Affairs
Lecture 217Introduction: GCC Pharmaceutical Market
Lecture 218GCC Registration Procedure - Centralized and Decentralized Procedure 
Lecture 219Drug Registration in Saudi Arabia
Lecture 220Drug Registration in UAE
Lecture 221Drug Registration in Kuwait
Lecture 222Drug Registration in Bahrain
Lecture 223Drug Registration in Oman
Lecture 224Documentation Required for the GCC countries 
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 Regulation and Registration Process
Lecture 232
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