InstructorRoyed Training
TypeOnline Course
Student Enrolled7
Price$790 USD / 35500 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

Free add on course

Regulatory Course Comparison

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

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

Free Add on certification course

  • This course comes with 2 credit of add on certification course. Hence, participants of PG Certification in Drug, Biologic and Medical Devices 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 17Clinical Trials Terminologies 
Lecture 18Clinical Trial Protocol Writing
Lecture 19Ethics in Clinical Research
Lecture 20Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 21FDA Forms and How to fill the resources
Lecture 22Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 2Innovation / Intellectual Property Management
Lecture 23Introduction to intellectual Property Management
Lecture 24Introduction to Patent 
Lecture 25Understanding on Patent System
Lecture 26Patent Grant and Managing Patent Filing Procedure
Lecture 27Scope of Patentability 
Lecture 28Patent Grant and Handling Process in India 
Lecture 29Stages of Patent Grant Procedure
Lecture 30Patent search in Indian Patent Office
Lecture 31Differences in US and European Patent
Lecture 32Patent Claim | Types of Patent Claims 
Lecture 33Patent Cliff | How to calculate the patent cliff
Lecture 34Terminologies related to patent, trademark, copyright and licensing 
Lecture 35Patent Infringement
Lecture 36Introduction to Trademark | Trademark filing procedure
Lecture 37Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 38Trademark Infringement | Passing off | Practical Cases
Lecture 39Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3 Regulatory Strategic Management and planning
Lecture 40Regulatory Strategies in different phases of Clinical Trial
Lecture 41Advance study on Para IV Filing
Lecture 42Para IV Notice
Lecture 43Evergreening - Patent Life Extension Strategies
Lecture 44Pay For Delay Strategy
Lecture 45REMS Strategic Planning
Lecture 46Compulsory Licensing
Lecture 47Licensing & Technology Transfer
Lecture 48In-Licensing Vs. Outlicensing
Lecture 49LOE Strategies for Innovator Brands with case study
Lecture 50Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 51Drug Re-purposing
Lecture 52Practical Queries on different USFDA application and Filing
Lecture 53Publication Management from Regulatory perspective
Lecture 54Juxtapid Case Study
Lecture 55New Indication Approval Process and Promotion
Lecture 56OTC Switch
Section 4Good Manufacturing Practices
Lecture 57Certification Pharmaceutical Companies / Plants
Lecture 58Premises & Plant Layout Designing
Lecture 59Sanitation and Hygiene
Lecture 60Equipment
Lecture 61Production Modules
Lecture 62GMP Documentation
Lecture 63Quality Control
Lecture 64Handling of Product Complaint
Lecture 65GMP Storage
Lecture 66ISO and ISO Audits
Lecture 67Pharmaceutical SOPs
Lecture 68PDE Value | Importance, Significance | How to calculate PDE value 
Lecture 69Quality 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 70Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 71CMC Dossier & Compliance Management
Lecture 72Electronic Common Technical Document (ECTD)
Lecture 73Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 74Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 75Key Consideration for Drug Master File Preparation and Submission 
Lecture 76Practical Understanding on Drug Master File Preparation and Submission
Lecture 77Site Master File - Detailed Understanding 
Lecture 78DMF Completeness Assessment
Lecture 79Drug Master File - Fees
Lecture 80Drug Master File - Global Perspective [Across Different Regions]
Lecture 81Importance of effective dossier management
Lecture 82Common deficiencies in CTD submission dossier
Lecture 83Certificate of Analysis
Lecture 84Detailed Understanding on ANDA Fees
Lecture 85Prior Approval Submission 
Lecture 86Detailed Understanding on ANDA Fees
Lecture 87Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 88NCE Vs. 505b2 application - Case Based Learning 
Lecture 89FTF - 180 Days Exclusivity - Case Based Learning
Lecture 90Classic case study of the 505b2 filing : Case Based Learning
Lecture 91Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 92Climate Zone
Lecture 93Stability Zone Finder
Lecture 94Stability Studies : Case discussions
Lecture 95Stability Data for Zone IV countries
Lecture 96Accelerated and intermediate testing conditions
Lecture 97Long Term Stability Testing Requirements
Lecture 98Stability Study Protocol Development - Dosage form: Capsule
Lecture 99Stability Data Sheet
Lecture 100Dossier Stability Test
Lecture 101Testing Frequency
Lecture 102Bracketing
Lecture 103Matrixing
Lecture 104PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 105Bioequivalence Study | Study design | Different types of BE Studies
Lecture 106Bioequivalence 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 107Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 108Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 109Bioequivalence Study - Discussion - Dissolution Testing
Lecture 110Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 111Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 112Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 113Data Integrity issues in Pharmaceutical Industry
Lecture 114Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 115Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 116RTQs | Response to Queries | How to handle Regulatory Queries  
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 117Introduction of Biologics
Lecture 118Classification of Biopharmaceutical 
Lecture 119Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 120Differences in Chemical Drug Vs. Biologic Drugs | Key features of Biologic
Lecture 121Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 122Recombinant protein
Lecture 123Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 124Monoclonal Antibodies
Lecture 125Synthetic Immunomodulators
Lecture 126Production of Monoclonal Antibodies
Lecture 127Cytokines
Lecture 128Interferon
Lecture 129Erythropoiesis-stimulating agent
Lecture 130Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 131Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 132Purple Book: Significance | Searching | Assignments
Lecture 133Vaccine development and approval Process
Lecture 134PDUFA For Biologics
Lecture 135Biosimilar Development Process
Lecture 136Strategic Consideration for Biosimilar Development 
Lecture 137Bio-Manufacturing Process Information
Lecture 138Studies required for approval of biosimilar
Section 8Medical Devices Regulation
Lecture 139Overall Understanding of US Medical Devices
Lecture 140Definition of Medical Devices
Lecture 141Classification of Medical Devices
Lecture 142Medical Devices Classification : Work File 
Lecture 143Review Test
Lecture 144510k - Pre-market Notification
Lecture 145Predicate Devices | Substantially Equivalent (SE)
Lecture 146Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 147FDA decision making process for different classes of 510k applications
Lecture 148Review Test
Lecture 149Premarket approval (PMA) application
Lecture 150Differences between 510k VS. PMA
Lecture 151Data Requirements for A Premarket Approval (PMA) application
Lecture 152PMA - Labeling Requirement for Medical Devices 
Lecture 153Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 154Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical tria
Lecture 155Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 156Expedited review of devices
Lecture 157Unapproved use of Medical Devices 
Lecture 158Marketing, Advertising and Promotion of Medical Devices
Lecture 159DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 160Humanitarian Device Exemption (HDE)
Lecture 161Combination Products | Types | Definition | Strategic Pathway
Lecture 162Medical Devices Regulation in Canada
Lecture 163Medical Devices: EU Directives, Classification and Guidance, CE Marking
Lecture 164Quality Management System (QMS) for medical devices company 
Lecture 165CE Marking Process | Strategic Planning | Requirements
Lecture 166c-GMP Requirement for Medical Devices
Lecture 167Product Recall | Product Withdrawal | Handling and Management of Product Recall 
Lecture 168ISO 13485 - Requirements | Handling of ISO auidts
Lecture 169Medical 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 170Medical Devices Regulation in Latam Countries:  Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Lecture 171Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Section 9European Drug Regulatory Affairs
Lecture 172Introduction to EU Regulation 
Lecture 173Orientation to European Countries and National Regulatory Bodies
Lecture 174EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 175Overview of EU Regulation 
Lecture 176EMA and EMA Authorisation Process
Lecture 177EU MA Application Types and Strategic Planning
Lecture 178EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 179EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 180Validity 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 181Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 182EU Orphan Medicinal Products Regulation
Lecture 183Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 184Summary of Product Characteristics 
Lecture 185Compassionate Use
Lecture 186MHRA - UK Regulation 
Lecture 187The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 188Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 189EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 190EU Prime Designation 
Lecture 191Accelerated assessment by EMEA
Lecture 192EU Adaptive Pathway
Lecture 193European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 194SPOR  - Concept of Master Data Management  
Lecture 195PDE Value : What is PDE value of API? Significance and How PDE value is derived? 
Section 10ASEAN Drug Regulatory Affairs
Lecture 196Introduction to ASEAN - Drug Regulatory Affairs 
Lecture 197ASEAN Countries | Introduction | Geographical Overview 
Lecture 198ASEAN countries drug regulatory bodies
Lecture 199ASEAN Common Technical Requirements (ACTRs)
Lecture 200The Pharmaceutical Inspection Co-operation Scheme
Lecture 201CPP Requirements for Drug Registration in ASEAN countries
Lecture 202Dossier Requirements - ACTD/CTD Acceptability
Lecture 203Pharmacopoeias Acceptability
Lecture 204Harmonization of Technical Guidelines 
Lecture 205Stability Study requirements for drug registration in ASEAN countries
Lecture 206Guideline on product labelling
Lecture 207Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 208Pharmacovigilance and Risk Management Plan (RMP)
Lecture 209Timeline of Drug Registration Approval
Lecture 210ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 211Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 212Drug Registration and Regulation in Brunei
Lecture 213Drug Registration and Regulation in Cambodia
Section 11African Drug Regulatory Affairs
Lecture 214African Continent Overview - Brief introduction to course
Lecture 215African Pharma Market
Lecture 216Drug Registration - African medicines regulatory agencies
Lecture 217Basic Export Requirement for African Countries
Lecture 218Export Documentations & Important Concepts
Lecture 219Drug Registration and Regulation in Nigeria
Lecture 220Drug Registration in Algeria
Lecture 221Drug Registration in Ethiopia
Lecture 222Drug Registration in Kenya
Lecture 223Drug Registration in Egypt
Lecture 224Drug Registration in Ghana
Lecture 225Drug Registration in Botswana
Lecture 226Drug Registration and Regulation in Uganda
Lecture 227Drug Registration in Zambia
Section 12Latam Regulatory Affairs
Lecture 228Introduction to Latam 
Lecture 229Drug Registration and Regulation in Argentina 
Lecture 230Drug Registration and Regulation in Bolivia
Lecture 231Drug Registration and Regulation in Brazil 
Lecture 232Drug Registration and Regulation in CHILE
Lecture 233Drug Registration and Regulation in Colombia
Lecture 234Drug Registration and Regulation in Mexico
Section 13GCC Drug Regulatory Affairs
Lecture 235Introduction: GCC Pharmaceutical Market
Lecture 236GCC Registration Procedure - Centralized and Decentralized Procedure 
Lecture 237Drug Registration in Saudi Arabia
Lecture 238Drug Registration in UAE
Lecture 239Drug Registration in Kuwait
Lecture 240Drug Registration in Bahrain
Lecture 241Drug Registration in Oman
Lecture 242Documentation Required for the GCC countries 
Section 14China Drug Regulatory Affairs
Lecture 243Drug Registration and Regulation in China
Lecture 244China NMPA New Regulation Update July, 2020
Section 15Russia Drug Regulatory Affairs
Section 16References | Discussions
Lecture 246Comparison of Requirement of Various Regulatory Bodies
Lecture 247Comparison of Dossier Requirements of Europe and US
Lecture 248Comparison of DMF requirement of various regulatory bodies