InstructorRoyed Training
TypeOnline Course
Price$690 USD / 34500 INR.
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international drug regulatory affairs

Introduction

Nature of course

Course Duration

Eligibility

Certification

Features

Related Courses

RA Course comparison

Free add on course

Regulatory Course Comparison

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.

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

Free Add on certification course

  • This course comes with 2 credit of add on certification course. Hence, participants of PG Certification in Drug, Biologic will receive two add on certification. One – 1 month course and also one 1-week course.
  • Participant can choose add on courses of any 1 month or 1 week certification course. You can find the various available courses here.
  • There will be no fees  for add on courses and courses can be opted any time during the main course access period, i.e. 1 year.
  • On completion of add on course, participant will be issuing course certificate.

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

 

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 6Complete Response Letter | Key understanding | Management and Action Plan
Lecture 7Handling of orange book
Lecture 8USFDA Expedited Programs (Detailed Understanding)
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Concept of Authorized Generics: Key Understanding
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 14Advance Learning on 505B2 Pathway
Lecture 15Chemistry, Manufacturing & Controls - Fundamental Understanding
Lecture 16Review on Drug Discovery and Development 
Lecture 17Understanding on Clinical Trials  and Clinical Research 
Lecture 18Clinical Trial Protocol Writing
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 22FDA Forms and How to fill the resources
Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 2Innovation Management in Pharmaceutical and Biopharmaceutical Organization
Lecture 24Introduction to intellectual Property Management
Lecture 25Clinical Trial Protocol Writing
Lecture 26Understanding on Patent System
Lecture 27Patent Grant and Managing Patent Filing Procedure
Lecture 28Scope of Patentability 
Lecture 29Patent Grant and Handling Process in India 
Lecture 30Stages of Patent Grant Procedure
Lecture 31Patent search in Indian Patent Office
Lecture 32Differences in US and European Patent
Lecture 33Patent Claim | Types of Patent Claims 
Lecture 34Patent Cliff | How to calculate the patent cliff
Lecture 35Terminologies related to patent, trademark, copyright and licensing 
Lecture 36Patent Infringement
Lecture 37Introduction to Trademark | Trademark filing procedure
Lecture 38Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 39Trademark Infringement | Passing off | Practical Cases
Lecture 40Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3 Regulatory Strategic Management and planning
Lecture 41Regulatory Strategies in different phases of Clinical Trial
Lecture 42Advance study on Para IV Filing
Lecture 43Para IV Notice
Lecture 44Evergreening - Patent Life Extension Strategies
Lecture 45Pay For Delay Strategy
Lecture 46REMS Strategic Planning
Lecture 47Compulsory Licensing
Lecture 48Licensing & Technology Transfer
Lecture 49In-Licensing Vs. Outlicensing
Lecture 50LOE Strategies for Innovator Brands with case study
Lecture 51Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 52Drug Re-purposing
Lecture 53Practical Queries on different USFDA application and Filing
Lecture 54Publication Management from Regulatory perspective
Lecture 55Juxtapid Case Study
Lecture 56New Indication Approval Process and Promotion
Lecture 57OTC Switch
Section 4Good Manufacturing Practices
Lecture 58Certification Pharmaceutical Companies / Plants
Lecture 59Premises & Plant Layout Designing
Lecture 60Sanitation and Hygiene
Lecture 61Equipment
Lecture 62Production Modules
Lecture 63GMP Documentation
Lecture 64Quality Control
Lecture 65Handling of Product Complaint
Lecture 66GMP Storage
Lecture 67ISO and ISO Audits
Lecture 68Pharmaceutical SOPs
Lecture 69SOP Automation
Lecture 70PDE Value | Importance, Significance | How to calculate PDE value 
Lecture 71Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 72Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 73CMC Dossier & Compliance Management
Lecture 74Electronic Common Technical Document (ECTD)
Lecture 75Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 76Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 77Key Consideration for Drug Master File Preparation and Submission 
Lecture 78Practical Understanding on Drug Master File Preparation and Submission
Lecture 79Site Master File - Detailed Understanding 
Lecture 80DMF Completeness Assessment
Lecture 81Drug Master File - Fees
Lecture 82Drug Master File - Global Perspective [Across Different Regions]
Lecture 83Importance of effective dossier management
Lecture 84Common deficiencies in CTD submission dossier
Lecture 85Certificate of Analysis
Lecture 86Detailed Understanding on ANDA Fees
Lecture 87Prior Approval Submission 
Lecture 88Detailed Understanding on ANDA Fees
Lecture 89Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 90NCE Vs. 505b2 application - Case Based Learning 
Lecture 91FTF - 180 Days Exclusivity - Case Based Learning
Lecture 92Classic case study of the 505b2 filing : Case Based Learning
Lecture 93Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 94Climate Zone
Lecture 95Stability Zone Finder
Lecture 96Stability Studies : Case discussions
Lecture 97Stability Data for Zone IV countries
Lecture 98Accelerated and intermediate testing conditions
Lecture 99Long Term Stability Testing Requirements
Lecture 100Stability Study Protocol Development - Dosage form: Capsule
Lecture 101Stability Data Sheet
Lecture 102Dossier Stability Test
Lecture 103Testing Frequency
Lecture 104Bracketing
Lecture 105Matrixing
Lecture 106PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 107Bioequivalence Study | Study design | Different types of BE Studies
Lecture 108Bioequivalence 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 109Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 110Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 111Bioequivalence Study - Discussion - Dissolution Testing
Lecture 112Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 113Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 114Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 115Data Integrity issues in Pharmaceutical Industry
Lecture 116Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 117Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 118RTQs | Response to Queries | How to handle Regulatory Queries  
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 119Introduction of Bilogics
Lecture 120Classification of Biopharmaceutical 
Lecture 121Chemical Drugs Vs. Biologic Drugs
Lecture 122Principle of Naming of Biologics
Lecture 123Global Biologics Market – By Product
Lecture 124Recombinant protein
Lecture 125Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 126Monoclonal Antibodies
Lecture 127Synthetic Immunomodulators
Lecture 128Production of Monoclonal Antibodies
Lecture 129Cytokines
Lecture 130Interferon
Lecture 131Erythropoiesis-stimulating agent
Lecture 132Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 133Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 134Purple Book: Significance | Searching | Assignments
Lecture 135Vaccine development and approval Process
Lecture 136PDUFA For Biologics
Lecture 137Biosimilar Development Process
Lecture 138Strategic Consideration for Biosimilar Development 
Lecture 139Bio-Manufacturing Process Information
Lecture 140Studies required for approval of biosimilar
Section 8European Drug Regulatory Affairs
Lecture 141Introduction to EU Regulation 
Lecture 142Orientation to European Countries and National Regulatory Bodies
Lecture 143EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 144Overview of EU Regulation 
Lecture 145EMA and EMA Authorisation Process
Lecture 146EU MA Application Types and Strategic Planning
Lecture 147EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 148EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 149Validity 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 150Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 151EU Orphan Medicinal Products Regulation
Lecture 152Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 153Summary of Product Characteristics 
Lecture 154Compassionate Use
Lecture 155MHRA - UK Regulation 
Lecture 156The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 157Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 158EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 159EU Prime Designation 
Lecture 160Accelerated assessment by EMEA
Lecture 161EU Adaptive Pathway
Lecture 162European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 163SPOR  - Concept of Master Data Management  
Lecture 164PDE Value : What is PDE value of API? Significance and How PDE value is derived? 
Section 9ASEAN Drug Regulatory Affairs
Lecture 165Introduction to ASEAN - Drug Regulatory Affairs 
Lecture 166ASEAN Countries | Introduction | Geographical Overview 
Lecture 167ASEAN countries drug regulatory bodies
Lecture 168ASEAN Common Technical Requirements (ACTRs)
Lecture 169The Pharmaceutical Inspection Co-operation Scheme
Lecture 170CPP Requirements for Drug Registration in ASEAN countries
Lecture 171Dossier Requirements - ACTD/CTD Acceptability
Lecture 172Pharmacopoeias Acceptability
Lecture 173Harmonization of Technical Guidelines 
Lecture 174Stability Study requirements for drug registration in ASEAN countries
Lecture 175Guideline on product labelling
Lecture 176Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 177Pharmacovigilance and Risk Management Plan (RMP)
Lecture 178Timeline of Drug Registration Approval
Lecture 179ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 180Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 181Drug Registration and Regulation in Brunei
Lecture 182Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 183African Continent Overview - Brief introduction to course
Lecture 184African Pharma Market
Lecture 185Drug Registration - African medicines regulatory agencies
Lecture 186Basic Export Requirement for African Countries
Lecture 187Export Documentations & Important Concepts
Lecture 188Drug Registration and Regulation in Nigeria
Lecture 189Drug Registration in Algeria
Lecture 190Drug Registration in Ethiopia
Lecture 191Drug Registration in Kenya
Lecture 192Drug Registration in Egypt
Lecture 193Drug Registration in Ghana
Lecture 194Drug Registration in Botswana
Lecture 195Drug Registration and Regulation in Uganda
Lecture 196Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 197Introduction to Latam 
Lecture 198Drug Registration and Regulation in Argentina 
Lecture 199Drug Registration and Regulation in Bolivia
Lecture 200Drug Registration and Regulation in Brazil 
Lecture 201Drug Registration and Regulation in CHILE
Lecture 202Drug Registration and Regulation in Colombia
Lecture 203Drug Registration and Regulation in Mexico
Section 12GCC Drug Regulatory Affairs
Lecture 204Introduction: GCC Pharmaceutical Market
Lecture 205GCC Registration Procedure - Centralized and Decentralized Procedure 
Lecture 206Drug Registration in Saudi Arabia
Lecture 207Drug Registration in UAE
Lecture 208Drug Registration in Kuwait
Lecture 209Drug Registration in Bahrain
Lecture 210Drug Registration in Oman
Lecture 211Documentation Required for the GCC countries 
Section 13China Drug Regulatory Affairs
Lecture 212Drug Registration and Regulation in China
Lecture 213China NMPA New Regulation Update July, 2020
Section 14Russia Drug Regulatory Affairs
Section 15References | Discussions
Lecture 215Comparison of Requirement of Various Regulatory Bodies
Lecture 216Comparison of Dossier Requirements of Europe and US
Lecture 217Comparison of DMF requirement of various regulatory bodies