InstructorRoyed Training
TypeOnline Course
Student Enrolled3
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 !
Lecture 24Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Section 2Innovation Management in Pharmaceutical and Biopharmaceutical Organization
Lecture 25Introduction to intellectual Property Management
Lecture 26Clinical Trial Protocol Writing
Lecture 27Understanding on Patent System
Lecture 28Patent Grant and Managing Patent Filing Procedure
Lecture 29Scope of Patentability 
Lecture 30Patent Grant and Handling Process in India 
Lecture 31Stages of Patent Grant Procedure
Lecture 32Patent search in Indian Patent Office
Lecture 33Differences in US and European Patent
Lecture 34Patent Claim | Types of Patent Claims 
Lecture 35Patent Cliff | How to calculate the patent cliff
Lecture 36Terminologies related to patent, trademark, copyright and licensing 
Lecture 37Patent Infringement
Lecture 38Introduction to Trademark | Trademark filing procedure
Lecture 39Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 40Trademark Infringement | Passing off | Practical Cases
Lecture 41Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3 Regulatory Strategic Management and planning
Lecture 42Regulatory Strategies in different phases of Clinical Trial
Lecture 43Advance study on Para IV Filing
Lecture 44Para IV Notice
Lecture 45Evergreening - Patent Life Extension Strategies
Lecture 46Pay For Delay Strategy
Lecture 47REMS Strategic Planning
Lecture 48Compulsory Licensing
Lecture 49Licensing & Technology Transfer
Lecture 50In-Licensing Vs. Outlicensing
Lecture 51LOE Strategies for Innovator Brands with case study
Lecture 52Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 53Drug Re-purposing
Lecture 54Practical Queries on different USFDA application and Filing
Lecture 55Publication Management from Regulatory perspective
Lecture 56Juxtapid Case Study
Lecture 57New Indication Approval Process and Promotion
Lecture 58OTC Switch
Section 4Good Manufacturing Practices
Lecture 59Certification Pharmaceutical Companies / Plants
Lecture 60Premises & Plant Layout Designing
Lecture 61Sanitation and Hygiene
Lecture 62Equipment
Lecture 63Production Modules
Lecture 64GMP Documentation
Lecture 65Quality Control
Lecture 66Handling of Product Complaint
Lecture 67GMP Storage
Lecture 68ISO and ISO Audits
Lecture 69Pharmaceutical SOPs
Lecture 70SOP Automation
Lecture 71PDE Value | Importance, Significance | How to calculate PDE value 
Lecture 72Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 73Introduction 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 74WHO-GMP Certification Scheme 
Lecture 75Template 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 76Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 77CMC Dossier & Compliance Management
Lecture 78Electronic Common Technical Document (ECTD)
Lecture 79Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 80Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 81Key Consideration for Drug Master File Preparation and Submission 
Lecture 82Practical Understanding on Drug Master File Preparation and Submission
Lecture 83Site Master File - Detailed Understanding 
Lecture 84DMF Completeness Assessment
Lecture 85Drug Master File - Fees
Lecture 86Drug Master File - Global Perspective [Across Different Regions]
Lecture 87Importance of effective dossier management
Lecture 88Common deficiencies in CTD submission dossier
Lecture 89Certificate of Analysis
Lecture 90Detailed Understanding on ANDA Fees
Lecture 91Prior Approval Submission 
Lecture 92Detailed Understanding on ANDA Fees
Lecture 93Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 94NCE Vs. 505b2 application - Case Based Learning 
Lecture 95FTF - 180 Days Exclusivity - Case Based Learning
Lecture 96Classic case study of the 505b2 filing : Case Based Learning
Lecture 97Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 98Climate Zone
Lecture 99Stability Zone Finder
Lecture 100Stability Studies : Case discussions
Lecture 101Stability Data for Zone IV countries
Lecture 102Accelerated and intermediate testing conditions
Lecture 103Long Term Stability Testing Requirements
Lecture 104Stability Study Protocol Development - Dosage form: Capsule
Lecture 105Stability Data Sheet
Lecture 106Dossier Stability Test
Lecture 107Testing Frequency
Lecture 108Bracketing
Lecture 109Matrixing
Lecture 110PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 111Bioequivalence Study | Study design | Different types of BE Studies
Lecture 112Bioequivalence 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 113Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 114Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 115Bioequivalence Study - Discussion - Dissolution Testing
Lecture 116Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 117Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 118Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 119Data Integrity issues in Pharmaceutical Industry
Lecture 120Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 121Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 122RTQs | Response to Queries | How to handle Regulatory Queries  
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 123Introduction of Bilogics
Lecture 124Classification of Biopharmaceutical 
Lecture 125Chemical Drugs Vs. Biologic Drugs
Lecture 126Principle of Naming of Biologics
Lecture 127Global Biologics Market – By Product
Lecture 128Recombinant protein
Lecture 129Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 130Monoclonal Antibodies
Lecture 131Synthetic Immunomodulators
Lecture 132Production of Monoclonal Antibodies
Lecture 133Cytokines
Lecture 134Interferon
Lecture 135Erythropoiesis-stimulating agent
Lecture 136Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 137Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 138Purple Book: Significance | Searching | Assignments
Lecture 139Vaccine development and approval Process
Lecture 140PDUFA For Biologics
Lecture 141Biosimilar Development Process
Lecture 142Strategic Consideration for Biosimilar Development 
Lecture 143Bio-Manufacturing Process Information
Lecture 144Studies required for approval of biosimilar
Section 8European Drug Regulatory Affairs
Lecture 145Introduction to EU Regulation 
Lecture 146Orientation to European Countries and National Regulatory Bodies
Lecture 147EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 148Overview of EU Regulation 
Lecture 149EMA and EMA Authorisation Process
Lecture 150EU MA Application Types and Strategic Planning
Lecture 151EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 152EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 153Validity 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 154Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 155EU Orphan Medicinal Products Regulation
Lecture 156Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 157Summary of Product Characteristics 
Lecture 158Compassionate Use
Lecture 159MHRA - UK Regulation 
Lecture 160The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 161Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 162EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 163EU Prime Designation 
Lecture 164Accelerated assessment by EMEA
Lecture 165EU Adaptive Pathway
Lecture 166European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 167SPOR  - Concept of Master Data Management  
Lecture 168PDE Value : What is PDE value of API? Significance and How PDE value is derived? 
Section 9ASEAN Drug Regulatory Affairs
Lecture 169Introduction to ASEAN - Drug Regulatory Affairs 
Lecture 170ASEAN Countries | Introduction | Geographical Overview 
Lecture 171ASEAN countries drug regulatory bodies
Lecture 172ASEAN Common Technical Requirements (ACTRs)
Lecture 173The Pharmaceutical Inspection Co-operation Scheme
Lecture 174CPP Requirements for Drug Registration in ASEAN countries
Lecture 175Dossier Requirements - ACTD/CTD Acceptability
Lecture 176Pharmacopoeias Acceptability
Lecture 177Harmonization of Technical Guidelines 
Lecture 178Stability Study requirements for drug registration in ASEAN countries
Lecture 179Guideline on product labelling
Lecture 180Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 181Pharmacovigilance and Risk Management Plan (RMP)
Lecture 182Timeline of Drug Registration Approval
Lecture 183ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 184Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 185Drug Registration and Regulation in Brunei
Lecture 186Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 187African Continent Overview - Brief introduction to course
Lecture 188African Pharma Market
Lecture 189Drug Registration - African medicines regulatory agencies
Lecture 190Basic Export Requirement for African Countries
Lecture 191Export Documentations & Important Concepts
Lecture 192Drug Registration and Regulation in Nigeria
Lecture 193Drug Registration in Algeria
Lecture 194Drug Registration in Ethiopia
Lecture 195Drug Registration in Kenya
Lecture 196Drug Registration in Egypt
Lecture 197Drug Registration in Ghana
Lecture 198Drug Registration in Botswana
Lecture 199Drug Registration and Regulation in Uganda
Lecture 200Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 201Introduction to Latam 
Lecture 202Drug Registration and Regulation in Argentina 
Lecture 203Drug Registration and Regulation in Bolivia
Lecture 204Drug Registration and Regulation in Brazil 
Lecture 205Drug Registration and Regulation in CHILE
Lecture 206Drug Registration and Regulation in Colombia
Lecture 207Drug Registration and Regulation in Mexico
Section 12GCC Drug Regulatory Affairs
Lecture 208Introduction: GCC Pharmaceutical Market
Lecture 209GCC Registration Procedure - Centralized and Decentralized Procedure 
Lecture 210Drug Registration in Saudi Arabia
Lecture 211Drug Registration in UAE
Lecture 212Drug Registration in Kuwait
Lecture 213Drug Registration in Bahrain
Lecture 214Drug Registration in Oman
Lecture 215Documentation Required for the GCC countries 
Section 13China Drug Regulatory Affairs
Lecture 216Drug Registration and Regulation in China
Lecture 217China NMPA New Regulation Update July, 2020
Section 14Russia Drug Regulatory Affairs
Section 15References | Discussions
Lecture 219Comparison of Requirement of Various Regulatory Bodies
Lecture 220Comparison of Dossier Requirements of Europe and US
Lecture 221Comparison of DMF requirement of various regulatory bodies