InstructorRoyed Training
TypeOnline Course
Student Enrolled11
Price$930 USD / 46500 INR.
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Drug Biologic Medical Devices Regulatory Affairs course



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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. 

This comprehensive course in Drug, Biologic, and Medical Device Regulatory Affairs provides an in-depth understanding of the regulatory framework governing the development, approval, and post-market compliance of pharmaceuticals, biologics, and medical devices. This dynamic field plays a pivotal role in ensuring the safety and efficacy of healthcare products, as well as their timely market access. Participants will gain the knowledge and skills necessary to navigate the complex regulatory landscape, making them valuable assets to pharmaceutical and medical device companies, regulatory agencies, and related organizations.

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.
  • Healthcare professionals and researchers.
  • Quality assurance and quality control personnel.
  • FDA professionals and Government regulatory agency staff.
  • Those seeking a career in regulatory affairs.

Course Snapshots

  • Course Code: RYD-077
  • Title of the course: PG Certification in Drug, Biologic and Medical Devices Regulatory Affairs (PGDBMRA)
  • Nature of the course : 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.
  • Duration of the course : 1 Year
  • Eligibility: Graduation in any discipline.
  • Course Certification : Certificate will be provided at the end of the successful completion of the course

Objective of the course

  • Understand the regulatory requirements and processes for drugs, biologics, and medical devices in various global markets.
  • Gain insights into the lifecycle of these products, from development and clinical trials to post-market surveillance.
  • Learn to interpret and apply relevant regulations, guidelines, and standards from regulatory authorities, including the FDA, EMA, and other agencies.
  • Develop proficiency in preparing regulatory submissions and ensuring compliance with regulatory requirements.
  • Appreciate the ethical and safety considerations integral to regulatory affairs, including pharmacovigilance and quality management.
  • Acquire the skills to assess, mitigate, and manage risks associated with regulatory compliance.

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 and medical device 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

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 85Introduction to Common Technical Document (CTD)
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 | Global Biologics Market – By Product | By Therapeutic Class | By Region
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
Lecture 155Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 156Comparability of Biologics | Different Categories of Comparability | General Principles 
Lecture 157CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Lecture 158ATMPs | Types and Classification | Regulatory Mechanism 
Lecture 159mAB - At a glance
Lecture 160ATMPs - at a glance
Lecture 161CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 162Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs 
Section 8European Drug Regulatory Affairs
Lecture 163Introduction to EU Regulation 
Lecture 164Orientation to European Countries and National Regulatory Bodies
Lecture 165EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 166Overview of EU Regulation 
Lecture 167EMA and EMA Authorisation Process
Lecture 168EU MA Application Types and Strategic Planning
Lecture 169EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 170EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 171Validity 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 172Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 173EU Orphan Medicinal Products Regulation
Lecture 174Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 175Summary of Product Characteristics 
Lecture 176Compassionate Use
Lecture 177MHRA - UK Regulation 
Lecture 178The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 179Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 180EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 181EU Prime Designation 
Lecture 182Accelerated assessment by EMEA
Lecture 183EU Adaptive Pathway
Lecture 184European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 185SPOR  - Concept of Master Data Management  
Lecture 186PDE Value : What is PDE value of API? Significance and How PDE value is derived? 
Section 9ASEAN Drug Regulatory Affairs
Lecture 187Introduction to ASEAN - Drug Regulatory Affairs 
Lecture 188ASEAN Countries | Introduction | Geographical Overview 
Lecture 189ASEAN countries drug regulatory bodies
Lecture 190ASEAN Common Technical Requirements (ACTRs)
Lecture 191The Pharmaceutical Inspection Co-operation Scheme
Lecture 192CPP Requirements for Drug Registration in ASEAN countries
Lecture 193Dossier Requirements - ACTD/CTD Acceptability
Lecture 194Pharmacopoeias Acceptability
Lecture 195Harmonization of Technical Guidelines 
Lecture 196Stability Study requirements for drug registration in ASEAN countries
Lecture 197Guideline on product labelling
Lecture 198Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 199Pharmacovigilance and Risk Management Plan (RMP)
Lecture 200Timeline of Drug Registration Approval
Lecture 201ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 202Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 203Drug Registration and Regulation in Brunei
Lecture 204Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 205African Continent Overview - Brief introduction to course
Lecture 206African Pharma Market
Lecture 207Drug Registration - African medicines regulatory agencies
Lecture 208Basic Export Requirement for African Countries
Lecture 209Export Documentations & Important Concepts
Lecture 210Drug Registration and Regulation in Nigeria
Lecture 211Drug Registration in Algeria
Lecture 212Drug Registration in Ethiopia
Lecture 213Drug Registration in Kenya
Lecture 214Drug Registration in Egypt
Lecture 215Drug Registration in Ghana
Lecture 216Drug Registration in Botswana
Lecture 217Drug Registration and Regulation in Uganda
Lecture 218Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 219Introduction to Latam 
Lecture 220Drug Registration and Regulation in Argentina 
Lecture 221Drug Registration and Regulation in Bolivia
Lecture 222Drug Registration and Regulation in Brazil 
Lecture 223Drug Registration and Regulation in CHILE
Lecture 224Drug Registration and Regulation in Colombia
Lecture 225Drug Registration and Regulation in Mexico
Lecture 226Drug regulation and registration in El Salvador
Lecture 227Central America Drug Regulatory Affairs | Panama, Costa Rica, Guatemala, El Salvador, Honduras, Dominican Republic | RTCA guideline [2022]
Section 12Middle East and GCC Drug Regulatory Affairs
Lecture 228Middle East / MENA / GCC Countries Geographical Orientation 
Lecture 229Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 230GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 231Drug Registration in Saudi Arabia
Lecture 232Drug Registration in Kuwait
Lecture 233Drug Registration and Regulatory Strategic Planning for Iran
Lecture 234Drug Registration and Regulatory Strategic Planning for Israel
Lecture 235Drug Registration and Regulatory Strategic Planning for Jordan
Lecture 236Drug Registration and Regulatory Strategic Planning for Iraq
Section 13China Drug Regulatory Affairs
Lecture 237Drug Registration and Regulation in China
Lecture 238China NMPA New Regulation Update July, 2020
Section 14Russia Drug Regulatory Affairs
Lecture 239Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 240GMP requirements in Russia 
Section 15References | Discussions
Lecture 241Comparison of Requirement of Various Regulatory Bodies
Lecture 242Comparison of Dossier Requirements of Europe and US
Lecture 243Comparison of DMF requirement of various regulatory bodies
Section 16Drug Registration and Regulation in Japan
Lecture 244Introduction to Japan Drug Regulatory Affairs 
Lecture 245Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval 
Lecture 246Drug Approval System | GCP | PMDA requirements 
Lecture 247New Drug Application | Requirements | Review Process
Lecture 248Generic Drug Application Review and Approval 
Lecture 249Marketing Authorization Process for registration of pharmaceutical in Japan
Lecture 250API Registration in Japan | Step By Step Process
Lecture 251Generic Registration | Patent - Patent Term Extension | Exclusivity | Re-examination System | Pediatric Designation |  Patent Term Extension Case Studies
Lecture 252Priority Review Application | Criteria | Review Process | Timeline
Lecture 253Orphan Drug Designation in Japan
Lecture 254Japan DMF System | MF filing Process | Key points 
Lecture 255Strategic Approval Pathway - Formulation Approval Quoting MF
Lecture 256SAKIGAKE designation 
Section 17Drug Registration in India
Lecture 257Import Export of Pharmaceuticals from India
Lecture 258Medicine Export Criteria from India
Lecture 259Documents for conducting BE Study for Export
Lecture 260New Drug Approval in DCGI
Lecture 261Line Extension New Strength Approval
Section 18US MEDICAL DEVICES | Development to Commercialization Cycle
Lecture 262Overview of US Medical Devices Market
Lecture 263Definition of Medical Devices
Lecture 264Classification of Medical Devices
Lecture 265Medical Devices Classification : Work File 
Lecture 266Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Lecture 267How to establish the classification of the medical device 
Lecture 268FDA Product Code Database : Hands on Training
Lecture 269513(g) Application : Request, User Fees, Review Process
Lecture 270510k - Pre-market Notification
Lecture 271Predicate Devices | Substantially Equivalent (SE)
Lecture 272Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 273FDA decision making process for different classes of 510k applications
Lecture 274Review Test
Lecture 275Premarket approval (PMA) application
Lecture 276Differences between 510k VS. PMA
Lecture 277Data Requirements for A Premarket Approval (PMA) application
Lecture 278Data Requirements for A Premarket Approval (PMA) application
Lecture 279PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 280Labeling Requirement for Medical Devices 
Lecture 281Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 282Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 283Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 284Expedited review of devices
Lecture 285Expiration Dating
Lecture 286Device Master Files
Lecture 287Unapproved use of Medical Devices 
Lecture 288Marketing, Advertising and Promotion of Medical Devices
Lecture 289FDA 513(g)
Lecture 290DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 291Humanitarian Device Exemption (HDE)
Section 21EU Regulation of Medical Devices
Lecture 292EU MDR Classification
Lecture 293EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 294EU MDR  | Annexes | Key notes
Lecture 295EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 296EU MDR Guideline | EU MDR - Annexes 
Lecture 297EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart 
Lecture 298EU MDR Authorized Representatives | Mandate | Role and Responsibilities 
Lecture 299EU MDR Compliance Process 
Lecture 300Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special Devices 
Lecture 301Review : DDF DHF DMR MDF DHR 
Section 22QMS, Documentation and Dossier Preparation
Lecture 302Medical Device Technical File
Lecture 303Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier 
Lecture 304Quality Management System (QMS) for medical devices company 
Lecture 305Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 306Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File 
Lecture 307Medical Device Essential Principle Checklist | Documentation |  Open file
Lecture 308Implant Card | Regulatory Importance | Content | How to design 
Section 23Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents 
Lecture 309Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents 
Lecture 310Instruction for Use (IFU) | Design and Development of IFU 
Lecture 311UDI | Different Component | How to design  
Section 24CE Marking
Lecture 312CE Marking | Introduction | Self Certification | General principles of the CE marking | Manufacturer Responsibilities | Third Party Medical Device Manufacturing & CE Marking | Step By Step CE Marking Process
Lecture 313CE- Self Certification
Lecture 314General principles of the CE marking
Lecture 315Manufacturer Responsibilities
Lecture 316Third Party Medical Device Manufacturing & CE Marking
Lecture 317Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 318Few Common Terminologies used in Medical Devices Industry
Lecture 319Step By Step CE Marking Process
Lecture 320Case Study
Section 25ISO 13485
Lecture 321Introduction to ISO 13485 | Importance | Comparison with various other standards
Lecture 322ISO 13485 Documentations | Different Sections | Case Studies 
Lecture 323ISO 13485: 2016 - Different Clauses
Section 26Combination Product Regulatory Affairs
Lecture 324Combination Products Regulatory Affairs | Definition |  Types | Requirements | cGMP considerations | Risk Management | CAPA
Lecture 325Combination Product RFD Designation Process | Importance | Timeline | Outcome Management
Lecture 326Combination Products Pre-market Approval Process | Lead centers | Concept of Primary Mode of Action | Strategic Submission Pathways
Section 27Medical Device Regulation in India | CDSCO Regulation
Lecture 327Medical Devices Regulation in India | Overall understanding
Lecture 328Regulatory Landscape in India
Lecture 329Classification of the Medical Devices in India | Strategic Planning for the Submission 
Lecture 330Notified and Non-notified Device | Submission Strategic Planning 
Lecture 331Medical Devices Classification in India - Work Doc
Lecture 332Notified Devices | Registration Process
Lecture 333Medical Device Submission Strategic Pathways | Step by step Process
Lecture 334Medical Device Forms | Purposes
Lecture 335Non Regulatory Medical Devices
Lecture 336Medical Device Voluntary Registration | Documentation | Process
Lecture 337List of Notified Devices | Newly Notified Devices | Significance
Lecture 338List of Notified Bodies with CDSCO
Section 28Medical Devices Regulation in Asian Countries - UAE, Bangladesh, Bahrain, Indonesia, China, India, Iran, Jordan, Japan, Kuwait, Korea, Lebanon, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, Vietnam
Section 29Medical Devices Regulation in Latam Countries:  Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Section 30Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Lecture 341Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Lecture 342South Africa Medical Device Regulation
Lecture 343Egypt Medical Device Regulation
Lecture 344Kenya Medical Device Regulation
Lecture 345Nigeria Medical Device Regulation
Section 31MDSAP Training
Lecture 346Introduction to MDSAP | Objective | Significance | Role and responsibilities of stakeholders | Key benefits | MDSAP Process structure and Audit Tasks
Lecture 347QMS and MDSAP | Differences and Similarities | MDSAP Vs. ISO 13485 : Key objectives and differences 
Lecture 348MDSAP Stakeholders 
Lecture 349MDSAP Process Structure Audit Task
Lecture 350MDSAP Document Preparation