InstructorRoyed Training
TypeOnline Course
Student Enrolled9
Price$790 USD / 39500 INR.
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Drug Biologic Medical Devices Regulatory Affairs course by royed training

Introduction

Nature of course

Course Duration

Eligibility

Certification

Features

Related Courses

About RA

Regulatory Course Comparison

Add on Certification

Drug Biologic Medical Devices Regulatory Affairs course

This online drugs biologics medical devices regulatory affairs course provides understanding of regulation, registration process and strategic planning. This PG Certification trains Regulatory Affairs professionals for drug, biologic and medical devices Industry. This comprehensive drugs biologics medical devices 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 and medical devices discovery, development, investigational application, marketing authorization application, handling of different phases of clinical trial, generic approval process, Abbreviated drugs or medical devices approval process. Hence, the course covers fundamentals to advance learning on drugs, biologics and medical devices development, regulation, registration and strategic management processes. 

Who should attend this course? 

  • Those who are in the regulatory affairs and related department.
  • Professionals from drugs, biologics and medical devices 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-077

Title: PG Certification in Drug, Biologic and Medical Devices Regulatory Affairs (PGDBMRA)

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 Drugs, Biologics and Medical Devices Regulatory Affairs Course

  • This course covers all aspects of the drug, biologics and medical devices regulatory affairs in a single course. Hence, user need not to purchase the drugs, medical devices 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 and medical devices strategic planning.

Career in Regulatory Affairs

A career in Regulatory Affairs is very challenging, but highly rewarding. But at the same time, it opens up lot of opportunities for professionals. Companies always look for the trained professionals for regulatory affairs department. This is because, the regulatory job covers a variety of disciplines. Hence, Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

Comprehensive coverage of the topic from across different regional bodies

The drug, biologic and medical devices industry is growing at a rapid pace, but there is a rising concern over the safety and efficacy. Hence, the major objective of the regulatory department is to maintain safety and efficacy of the drugs and biopharmaceutical molecules. In fact, to maintain safety and efficacy in pharmaceutical and biopharmaceutical products, regulatory agencies like US FDA, EMA, MHRA UK, DCGI, TGA – Autrallia, NMPA – China etc. all over the world are imposing number of regulation. Moreover, these regulations are evolving and changing every other day. Regulatory professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decision effectively. This has resulted in creation of regulatory department with certified regulatory affairs professionals. And it help companies to meet these requirements with ease.

About regulatory affairs job>> Learn here

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 of Executive PG Certification in Drug Biologic Medical Devices 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 11Exploratory IND Vs. Traditional 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 
Lecture 34Handling of orange book
Section 2Innovation / Intellectual Property Management
Lecture 35Introduction to intellectual Property Management
Lecture 36Introduction to Patent 
Lecture 37Understanding on Patent System
Lecture 38Patent Grant and Managing Patent Filing Procedure
Lecture 39Scope of Patentability 
Lecture 40Patent Grant and Handling Process in India 
Lecture 41Stages of Patent Grant Procedure
Lecture 42Patent search in Indian Patent Office
Lecture 43Differences in US and European Patent
Lecture 44Patent Claim | Types of Patent Claims 
Lecture 45Patent Cliff | How to calculate the patent cliff
Lecture 46Terminologies related to patent, trademark, copyright and licensing 
Lecture 47Patent Infringement
Lecture 48Introduction to Trademark | Trademark filing procedure
Lecture 49Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 50Trademark Infringement | Passing off | Practical Cases
Lecture 51Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3 Regulatory Strategic Management and planning
Lecture 52Regulatory Strategies in different phases of Clinical Trial
Lecture 53Advance study on Para IV Filing
Lecture 54Para IV Notice
Lecture 55Evergreening - Patent Life Extension Strategies
Lecture 56Pay For Delay Strategy
Lecture 57REMS Strategic Planning
Lecture 58Compulsory Licensing
Lecture 59Licensing & Technology Transfer
Lecture 60In-Licensing Vs. Outlicensing
Lecture 61LOE Strategies for Innovator Brands with case study
Lecture 62Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 63Drug Re-purposing
Lecture 64Practical Queries on different USFDA application and Filing
Lecture 65Publication Management from Regulatory perspective
Lecture 66Juxtapid Case Study
Lecture 67New Indication Approval Process and Promotion
Lecture 68OTC Switch
Section 4Good Manufacturing Practices
Lecture 69Certification Pharmaceutical Companies / Plants
Lecture 70Premises & Plant Layout Designing
Lecture 71Sanitation and Hygiene
Lecture 72Equipment
Lecture 73Production Modules
Lecture 74GMP Documentation
Lecture 75Quality Control
Lecture 76Handling of Product Complaint
Lecture 77GMP Storage
Lecture 78ISO and ISO Audits
Lecture 79Pharmaceutical SOPs
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
Lecture 108Stability Zone Finder
Lecture 109Stability Studies : Case discussions
Lecture 110Stability Data for Zone IV countries
Lecture 111Accelerated and intermediate testing conditions
Lecture 112Long Term Stability Testing Requirements
Lecture 113Stability Study Protocol Development - Dosage form: Capsule
Lecture 114Stability Data Sheet
Lecture 115Dossier Stability Test
Lecture 116Testing Frequency
Lecture 117Bracketing
Lecture 118Matrixing
Lecture 119PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 120Bioequivalence Study | Study design | Different types of BE Studies
Lecture 121Bioequivalence 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 122Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 123Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 124Bioequivalence Study - Discussion - Dissolution Testing
Lecture 125Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 126Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 127Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Lecture 128Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System 
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 129Data Integrity issues in Pharmaceutical Industry
Lecture 130Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 131Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 132RTQs | Response to Queries | How to handle Regulatory Queries  
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 133Introduction of Biologics
Lecture 134Classification of Biopharmaceutical 
Lecture 135Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 136Differences in Chemical Drug Vs. Biologic Drugs | Key features of Biologic
Lecture 137Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 138Recombinant protein
Lecture 139Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 140Monoclonal Antibodies
Lecture 141Synthetic Immunomodulators
Lecture 142Production of Monoclonal Antibodies
Lecture 143Cytokines
Lecture 144Interferon
Lecture 145Erythropoiesis-stimulating agent
Lecture 146Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 147Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 148Purple Book: Significance | Searching | Assignments
Lecture 149Vaccine development and approval Process
Lecture 150PDUFA For Biologics
Lecture 151Biosimilar Development Process
Lecture 152Strategic Consideration for Biosimilar Development 
Lecture 153Bio-Manufacturing Process Information
Lecture 154Studies required for approval of biosimilar
Section 8Medical Devices Regulation
Lecture 155Overall Understanding of US Medical Devices
Lecture 156Definition of Medical Devices
Lecture 157Classification of Medical Devices
Lecture 158Medical Devices Classification : Work File 
Lecture 159Review Test
Lecture 160510k - Pre-market Notification
Lecture 161Predicate Devices | Substantially Equivalent (SE)
Lecture 162Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 163FDA decision making process for different classes of 510k applications
Lecture 164Review Test
Lecture 165Premarket approval (PMA) application
Lecture 166Differences between 510k VS. PMA
Lecture 167Data Requirements for A Premarket Approval (PMA) application
Lecture 168PMA - Labeling Requirement for Medical Devices 
Lecture 169Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 170Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical tria
Lecture 171Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 172Expedited review of devices
Lecture 173Unapproved use of Medical Devices 
Lecture 174Marketing, Advertising and Promotion of Medical Devices
Lecture 175DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 176Humanitarian Device Exemption (HDE)
Lecture 177Combination Products | Types | Definition | Strategic Pathway
Lecture 178Medical Devices Regulation in Canada
Lecture 179Medical Devices: EU Directives, Classification and Guidance, CE Marking
Lecture 180Quality Management System (QMS) for medical devices company 
Lecture 181CE Marking Process | Strategic Planning | Requirements
Lecture 182c-GMP Requirement for Medical Devices
Lecture 183Product Recall | Product Withdrawal | Handling and Management of Product Recall 
Lecture 184ISO 13485 - Requirements | Handling of ISO auidts
Lecture 185Medical Devices Regulation in Asian Countries - UAE, Bangladesh, Bahrain, Indonesia, China, India, Iran, Jordan, Japan, Kuwait, Korea, Lebanon, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, Vietnam
Lecture 186Medical Devices Regulation in Latam Countries:  Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Lecture 187Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Section 9European Drug Regulatory Affairs
Lecture 188Introduction to EU Regulation 
Lecture 189Orientation to European Countries and National Regulatory Bodies
Lecture 190EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 191Overview of EU Regulation 
Lecture 192EMA and EMA Authorisation Process
Lecture 193EU MA Application Types and Strategic Planning
Lecture 194EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 195EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 196Validity 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 197Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 198EU Orphan Medicinal Products Regulation
Lecture 199Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 200Summary of Product Characteristics 
Lecture 201Compassionate Use
Lecture 202MHRA - UK Regulation 
Lecture 203The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 204Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 205EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 206EU Prime Designation 
Lecture 207Accelerated assessment by EMEA
Lecture 208EU Adaptive Pathway
Lecture 209European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 210SPOR  - Concept of Master Data Management  
Lecture 211PDE Value : What is PDE value of API? Significance and How PDE value is derived? 
Section 10ASEAN Drug Regulatory Affairs
Lecture 212Introduction to ASEAN - Drug Regulatory Affairs 
Lecture 213ASEAN Countries | Introduction | Geographical Overview 
Lecture 214ASEAN countries drug regulatory bodies
Lecture 215ASEAN Common Technical Requirements (ACTRs)
Lecture 216The Pharmaceutical Inspection Co-operation Scheme
Lecture 217CPP Requirements for Drug Registration in ASEAN countries
Lecture 218Dossier Requirements - ACTD/CTD Acceptability
Lecture 219Pharmacopoeias Acceptability
Lecture 220Harmonization of Technical Guidelines 
Lecture 221Stability Study requirements for drug registration in ASEAN countries
Lecture 222Guideline on product labelling
Lecture 223Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 224Pharmacovigilance and Risk Management Plan (RMP)
Lecture 225Timeline of Drug Registration Approval
Lecture 226ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 227Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 228Drug Registration and Regulation in Brunei
Lecture 229Drug Registration and Regulation in Cambodia
Section 11African Drug Regulatory Affairs
Lecture 230African Continent Overview - Brief introduction to course
Lecture 231African Pharma Market
Lecture 232Drug Registration - African medicines regulatory agencies
Lecture 233Basic Export Requirement for African Countries
Lecture 234Export Documentations & Important Concepts
Lecture 235Drug Registration and Regulation in Nigeria
Lecture 236Drug Registration in Algeria
Lecture 237Drug Registration in Ethiopia
Lecture 238Drug Registration in Kenya
Lecture 239Drug Registration in Egypt
Lecture 240Drug Registration in Ghana
Lecture 241Drug Registration in Botswana
Lecture 242Drug Registration and Regulation in Uganda
Lecture 243Drug Registration in Zambia
Section 12Latam Regulatory Affairs
Lecture 244Introduction to Latam 
Lecture 245Drug Registration and Regulation in Argentina 
Lecture 246Drug Registration and Regulation in Bolivia
Lecture 247Drug Registration and Regulation in Brazil 
Lecture 248Drug Registration and Regulation in CHILE
Lecture 249Drug Registration and Regulation in Colombia
Lecture 250Drug Registration and Regulation in Mexico
Section 13GCC Drug Regulatory Affairs
Lecture 251Introduction: GCC Pharmaceutical Market
Lecture 252GCC Registration Procedure - Centralized and Decentralized Procedure 
Lecture 253Drug Registration in Saudi Arabia
Lecture 254Drug Registration in UAE
Lecture 255Drug Registration in Kuwait
Lecture 256Drug Registration in Bahrain
Lecture 257Drug Registration in Oman
Lecture 258Documentation Required for the GCC countries 
Section 14China Drug Regulatory Affairs
Lecture 259Drug Registration and Regulation in China
Lecture 260China NMPA New Regulation Update July, 2020
Section 15Russia Drug Regulatory Affairs
Section 16References | Discussions
Lecture 262Comparison of Requirement of Various Regulatory Bodies
Lecture 263Comparison of Dossier Requirements of Europe and US
Lecture 264Comparison of DMF requirement of various regulatory bodies