InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$750 USD / 34780 INR.
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drugs biologics medical devices regulatory affairs coruse

Introduction

Nature of course

Course Duration

Eligibility

Certification

Features

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About RA

Drugs biologics medical devices online training

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

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 
Section 2 Clinical Trial / Clinical Research
Lecture 17Clinical Trial Detailed Study
Lecture 18Clinical Trial Protocol Writing
Lecture 19Ethics in Clinical Research
Lecture 20FDA forms and How to fill FDA forms
Lecture 21Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 22Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 3 Regulatory Strategic Management and planning
Lecture 23Regulatory Strategies in different phases of Clinical Trial
Lecture 24Advance study on Para IV Filing
Lecture 25Para IV Notice
Lecture 26Evergreening - Patent Life Extension Strategies
Lecture 27Pay For Delay Strategy
Lecture 28REMS Strategic Planning
Lecture 29Compulsory Licensing
Lecture 30Licensing & Technology Transfer
Lecture 31In-Licensing Vs. Outlicensing
Lecture 32LOE Strategies for Innovator Brands with case study
Lecture 33Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 34Drug Re-purposing
Lecture 35Practical Queries on different USFDA application and Filing
Lecture 36Publication Management from Regulatory perspective
Lecture 37Juxtapid Case Study
Lecture 38New Indication Approval Process and Promotion
Lecture 39OTC Switch
Section 4Good Manufacturing Practices
Lecture 40Introduction to Good Manufacturing Practices
Lecture 41Premises & Plant Layout Designing
Lecture 42Sanitation and Hygiene
Lecture 43Equipment
Lecture 44Production Modules
Lecture 45GMP Documentation
Lecture 46Quality Control
Lecture 47Handling of Product Complaint
Lecture 48GMP Storage
Lecture 49ISO and ISO Audits
Lecture 50Pharmaceutical SOPs
Lecture 51SOP Automation
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 52Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 53CMC Dossier & Compliance Management
Lecture 54Electronic Common Technical Document (ECTD)
Lecture 55Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 56Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 57Key Consideration for Drug Master File Preparation and Submission 
Lecture 58Practical Understanding on Drug Master File Preparation and Submission
Lecture 59Site Master File - Detailed Understanding 
Lecture 60DMF Completeness Assessment
Lecture 61Drug Master File - Fees
Lecture 62Drug Master File - Global Perspective [Across Different Regions]
Lecture 63Importance of effective dossier management
Lecture 64Common deficiencies in CTD submission dossier
Lecture 65Certificate of Analysis
Lecture 66Detailed Understanding on ANDA Fees
Lecture 67Prior Approval Submission 
Lecture 68Detailed Understanding on ANDA Fees
Lecture 69Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 70NCE Vs. 505b2 application - Case Based Learning 
Lecture 71FTF - 180 Days Exclusivity - Case Based Learning
Lecture 72Classic case study of the 505b2 filing : Case Based Learning
Lecture 73Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 74Data Integrity issues in Pharmaceutical Industry
Lecture 75Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 76Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 77Introduction of Bilogics
Lecture 78Classification of Biopharmaceutical 
Lecture 79Chemical Drugs Vs. Biologic Drugs
Lecture 80Principle of Naming of Biologics
Lecture 81Global Biologics Market – By Product
Lecture 82Recombinant protein
Lecture 83Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 84Monoclonal Antibodies
Lecture 85Synthetic Immunomodulators
Lecture 86Production of Monoclonal Antibodies
Lecture 87Cytokines
Lecture 88Interferon
Lecture 89Erythropoiesis-stimulating agent
Lecture 90Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 91Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 92Purple Book: Significance | Searching | Assignments
Lecture 93Vaccine development and approval Process
Lecture 94PDUFA For Biologics
Lecture 95Biosimilar Development Process
Lecture 96Strategic Consideration for Biosimilar Development 
Lecture 97Bio-Manufacturing Process Information
Lecture 98Studies required for approval of biosimilar
Section 8Medical Devices Regulation
Lecture 99Overall Understanding of US Medical Devices
Lecture 100Definition of Medical Devices
Lecture 101Classification of Medical Devices
Lecture 102Medical Devices Classification : Work File 
Lecture 103Review Test
Lecture 104510k - Pre-market Notification
Lecture 105Predicate Devices | Substantially Equivalent (SE)
Lecture 106Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 107FDA decision making process for different classes of 510k applications
Lecture 108Review Test
Lecture 109Premarket approval (PMA) application
Lecture 110Differences between 510k VS. PMA
Lecture 111Data Requirements for A Premarket Approval (PMA) application
Lecture 112PMA - Labeling Requirement for Medical Devices 
Lecture 113Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 114Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical tria
Lecture 115Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 116Expedited review of devices
Lecture 117Unapproved use of Medical Devices 
Lecture 118Marketing, Advertising and Promotion of Medical Devices
Lecture 119DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 120Humanitarian Device Exemption (HDE)
Lecture 121Combination Products | Types | Definition | Strategic Pathway
Lecture 122Medical Devices Regulation in Canada
Lecture 123Medical Devices: EU Directives, Classification and Guidance, CE Marking
Lecture 124Quality Management System (QMS) for medical devices company 
Lecture 125CE Marking Process | Strategic Planning | Requirements
Lecture 126c-GMP Requirement for Medical Devices
Lecture 127Product Recall | Product Withdrawal | Handling and Management of Product Recall 
Lecture 128ISO 13485 - Requirements | Handling of ISO auidts
Lecture 129Medical 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 130Medical Devices Regulation in Latam Countries:  Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Lecture 131Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt