Drugs, Biologics and Medical Devices Regulatory Affairs Course

Drug Biologic Medical Devices Regulatory Affairs course by royed training

Introduction

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About RA

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.

We also have 1 year Executive PG certification in International Drug Regulatory Affairs course. This course covers comprehensive regulatory training on pharmaceutical and biopharmaceuticals. Hence, those who don’t require Medical Devices regulatory knowledge can opt for the international drug regulatory affairs course.

Few of the similar courses

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 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 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

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 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.

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 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 156Comparability of Biologics | Different Categories of Comparability | General Principles

Lecture 157CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)

Section 8European Drug Regulatory Affairs

Lecture 158Introduction to EU Regulation

Lecture 159Orientation to European Countries and National Regulatory Bodies

Lecture 160EU Drug Discovery Development to Commercialization (Step By Step)

Lecture 161Overview of EU Regulation

Lecture 162EMA and EMA Authorisation Process

Lecture 163EU MA Application Types and Strategic Planning

Lecture 164EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure

Lecture 165EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application

Lecture 166Validity 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 167Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae

Lecture 168EU Orphan Medicinal Products Regulation

Lecture 169Conditional marketing authorisation | Marketing authorisation under exceptional circumstances

Lecture 170Summary of Product Characteristics

Lecture 171Compassionate Use

Lecture 172MHRA - UK Regulation

Lecture 173The 'sunset clause' for marketing authorisation of pharmaceuticals

Lecture 174Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)

Lecture 175EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation

Lecture 176EU Prime Designation

Lecture 177Accelerated assessment by EMEA

Lecture 178EU Adaptive Pathway

Lecture 179European public assessment report (EPAR) - Importance, Component, Management, Updation

Lecture 180SPOR - Concept of Master Data Management

Lecture 181PDE Value : What is PDE value of API? Significance and How PDE value is derived?

Section 9ASEAN Drug Regulatory Affairs

Lecture 182Introduction to ASEAN - Drug Regulatory Affairs

Lecture 183ASEAN Countries | Introduction | Geographical Overview

Lecture 184ASEAN countries drug regulatory bodies

Lecture 185ASEAN Common Technical Requirements (ACTRs)

Lecture 186The Pharmaceutical Inspection Co-operation Scheme

Lecture 187CPP Requirements for Drug Registration in ASEAN countries

Lecture 188Dossier Requirements - ACTD/CTD Acceptability

Lecture 189Pharmacopoeias Acceptability

Lecture 190Harmonization of Technical Guidelines

Lecture 191Stability Study requirements for drug registration in ASEAN countries

Lecture 192Guideline on product labelling

Lecture 193Post Approval Changes (Variations) requirements in ASEAN countries

Lecture 194Pharmacovigilance and Risk Management Plan (RMP)

Lecture 195Timeline of Drug Registration Approval

Lecture 197Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management

Lecture 198Drug Registration and Regulation in Brunei

Lecture 199Drug Registration and Regulation in Cambodia

Section 10African Drug Regulatory Affairs

Lecture 200African Continent Overview - Brief introduction to course

Lecture 201African Pharma Market

Lecture 202Drug Registration - African medicines regulatory agencies

Lecture 203Basic Export Requirement for African Countries

Lecture 204Export Documentations & Important Concepts

Lecture 205Drug Registration and Regulation in Nigeria

Lecture 206Drug Registration in Algeria

Lecture 207Drug Registration in Ethiopia

Lecture 208Drug Registration in Kenya

Lecture 209Drug Registration in Egypt

Lecture 210Drug Registration in Ghana

Lecture 211Drug Registration in Botswana

Lecture 212Drug Registration and Regulation in Uganda

Lecture 213Drug Registration in Zambia

Section 11Latam Regulatory Affairs

Lecture 214Introduction to Latam

Lecture 215Drug Registration and Regulation in Argentina

Lecture 216Drug Registration and Regulation in Bolivia

Lecture 217Drug Registration and Regulation in Brazil

Lecture 218Drug Registration and Regulation in CHILE

Lecture 219Drug Registration and Regulation in Colombia

Lecture 220Drug Registration and Regulation in Mexico

Lecture 221Drug regulation and registration in El Salvador

Lecture 222Central 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 223Middle East / MENA / GCC Countries Geographical Orientation

Lecture 224Middle East / MENA / GCC Countries National Regulatory Agencies

Lecture 225GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process

Lecture 226Drug Registration in Saudi Arabia

Lecture 227Drug Registration in Kuwait

Lecture 228Drug Registration and Regulatory Strategic Planning for Iran

Lecture 229Drug Registration and Regulatory Strategic Planning for Israel

Lecture 230Drug Registration and Regulatory Strategic Planning for Jordan

Lecture 231Drug Registration and Regulatory Strategic Planning for Iraq

Section 13China Drug Regulatory Affairs

Lecture 232Drug Registration and Regulation in China

Lecture 233China NMPA New Regulation Update July, 2020

Section 14Russia Drug Regulatory Affairs

Lecture 234Drug Registration and Submission Strategic Planning for Russia and EAEU region

Lecture 235GMP requirements in Russia

Section 15References | Discussions

Lecture 236Comparison of Requirement of Various Regulatory Bodies

Lecture 237Comparison of Dossier Requirements of Europe and US

Lecture 238Comparison of DMF requirement of various regulatory bodies

Section 16Drug Registration and Regulation in Japan

Lecture 239Introduction to Japan Drug Regulatory Affairs

Lecture 240Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval

Lecture 241Drug Approval System | GCP | PMDA requirements

Lecture 242New Drug Application | Requirements | Review Process

Lecture 243Generic Drug Application Review and Approval

Section 17Drug Registration in India

Lecture 244Import Export of Pharmaceuticals from India

Lecture 245Medicine Export Criteria from India

Lecture 246Documents for conducting BE Study for Export

Lecture 247New Drug Approval in DCGI

Lecture 248Line Extension New Strength Approval

Section 18US MEDICAL DEVICES | Development to Commercialization Cycle

Lecture 249Overview of US Medical Devices Market

Lecture 250Definition of Medical Devices

Lecture 251Classification of Medical Devices

Lecture 252Medical Devices Classification : Work File

Lecture 253Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies

Lecture 254How to establish the classification of the medical device

Lecture 255FDA Product Code Database : Hands on Training

Lecture 256513(g) Application : Request, User Fees, Review Process

Section 19510K PRE-MARKET NOTIFICATION

Lecture 257510k - Pre-market Notification

Lecture 258Predicate Devices | Substantially Equivalent (SE)

Lecture 259Understanding on 510k | Types of the 510k | Timeline | Difference with PMA

Lecture 260FDA decision making process for different classes of 510k applications

Lecture 261Review Test

Section 20PREMARKET APPROVAL (PMA) APPLICATION

Lecture 262Premarket approval (PMA) application

Lecture 263Differences between 510k VS. PMA

Lecture 264Data Requirements for A Premarket Approval (PMA) application

Lecture 265Data Requirements for A Premarket Approval (PMA) application

Lecture 266PMA Post Submission - Management of CRL - Timeline and Strategic Planning

Lecture 267Labeling Requirement for Medical Devices

Lecture 268Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements

Lecture 269Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial

Lecture 270Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning

Lecture 271Expedited review of devices

Lecture 272Expiration Dating

Lecture 273Device Master Files

Lecture 274Unapproved use of Medical Devices

Lecture 275Marketing, Advertising and Promotion of Medical Devices

Lecture 276FDA 513(g)

Lecture 277DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning

Lecture 278Humanitarian Device Exemption (HDE)

Section 21EU Regulation of Medical Devices

Lecture 279EU MDR Classification

Lecture 281EU MDR | Annexes | Key notes

Lecture 283EU MDR Guideline | EU MDR - Annexes

Lecture 284EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart

Lecture 285EU MDR Authorized Representatives | Mandate | Role and Responsibilities

Lecture 286EU MDR Compliance Process

Lecture 287Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special Devices

Lecture 288Review : DDF DHF DMR MDF DHR

Section 22QMS, Documentation and Dossier Preparation

Lecture 289Medical Device Technical File

Lecture 290Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier

Lecture 291Quality Management System (QMS) for medical devices company

Lecture 292Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management

Lecture 293Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File

Lecture 294Medical Device Essential Principle Checklist | Documentation | Open file

Lecture 295Implant Card | Regulatory Importance | Content | How to design

Section 23Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents

Lecture 296Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents

Lecture 297Instruction for Use (IFU) | Design and Development of IFU

Lecture 298UDI | Different Component | How to design

Section 24CE Marking

Lecture 300CE- Self Certification

Lecture 301General principles of the CE marking

Lecture 302Manufacturer Responsibilities

Lecture 303Third Party Medical Device Manufacturing & CE Marking

Lecture 304Classifying Medical Devices Based on the Type of Manufacturing Operation

Lecture 305Few Common Terminologies used in Medical Devices Industry

Lecture 306Step By Step CE Marking Process

Lecture 307Case Study

Section 25ISO 13485

Lecture 308Introduction to ISO 13485 | Importance | Comparison with various other standards

Lecture 309ISO 13485 Documentations | Different Sections | Case Studies

Lecture 310ISO 13485: 2016 - Different Clauses

Section 26Combination Product Regulatory Affairs

Lecture 312Combination Product RFD Designation Process | Importance | Timeline | Outcome Management

Lecture 313Combination 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 314Medical Devices Regulation in India | Overall understanding

Lecture 315Regulatory Landscape in India

Lecture 316Classification of the Medical Devices in India | Strategic Planning for the Submission

Lecture 317Notified and Non-notified Device | Submission Strategic Planning

Lecture 318Medical Devices Classification in India - Work Doc

Lecture 319Notified Devices | Registration Process

Lecture 320Medical Device Submission Strategic Pathways | Step by step Process

Lecture 321Medical Device Forms | Purposes

Lecture 322Non Regulatory Medical Devices

Lecture 323Medical Device Voluntary Registration | Documentation | Process

Lecture 324List of Notified Devices | Newly Notified Devices | Significance

Lecture 325List 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

Drugs, Biologics and Medical Devices Regulatory Affairs Course

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Introduction

Features

Related Courses

About RA

Who should attend this course?

Course Snapshots

Objective of the course

Features of Drugs, Biologics and Medical Devices Regulatory Affairs Course

Case Based Learning

Few of the similar courses

Career in Regulatory Affairs

Comprehensive coverage of the topic from across different regional bodies

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Drugs, Biologics and Medical Devices Regulatory Affairs Course

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Download Course Catalogue

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Request for Course Demo Session

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Introduction

Features

Related Courses

About RA

Who should attend this course?

Course Snapshots

Objective of the course

Features of Drugs, Biologics and Medical Devices Regulatory Affairs Course

Case Based Learning

Few of the similar courses

Career in Regulatory Affairs

Comprehensive coverage of the topic from across different regional bodies