InstructorRoyed Training
TypeOnline Course
Price$550 USD / 25500 INR.
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drug regulatory affairs course

Introduction

Course Type

Course Duration

Eligibility

Certification

Features

Related Courses

About RA

Drug regulatory affairs course provides understanding of drug regulation, registration, marketing authorization submission management. Also, the course extensively covers the regulatory strategic management. drug regulatory affairs training course

This PG Certification is designed to create effective Regulatory Affairs Manager for Pharmaceutical Industry. Most importantly, this course provides practical knowledge and real life job simulation in the field of regulatory affairs. Hence, this course is ideal for the professionals work in regulatory affairs department. In fact, the major objective of the course is to inculcate the regulatory decision making skills for regulatory professionals.

Online Self Paced Learning

In this online self-paced modules, participant will be understanding about the drug development to commercialization process in detail. Then, stages of drug discovery and development, investigational new drug application, new drug application, handling of different phases of clinical trial, generic drug approval process, Abbreviated new drug applications will be covered in phased manner for easy understanding. Further more, the course will provides extensive training on dossier, drug master file, site master file preparation and filing. Above all, course covers the plant management and advanced plant certification management process in detail.

Who should attend this course? 

  • Those who are in regulatory affairs and related department.
  • Professionals from drug discovery development.
  • Anyone requiring an overview of drug regulatory affairs.
  • Fresher or beginners, Those who want to make a career in drug regulatory department.

Course Code: RYD-001

Online distance learning course. So, course can be accessed online across anywhere 24×7.

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

  • Orientation to job related practical aspects of the drug regulatory managers, is covered in this course extensively.
  • Simulation to real life working in regulatory affairs department. It help to enhance the regulatory strategic decision making.
  • Advance training on drug registration requirements for various regulatory bodies.
  • Access to Case Studies to learn about the drug registration steps.

Career in Drug Regulatory Affairs

A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

The Pharma and biopharma 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 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 – Australia, NMPA – China etc. all over the world are imposing number of regulation. Therefore, these regulations are evolving and changing every other day. Most importantly, regulatory professionals must have thorough knowledge about the updated regulations. Certainly, sound regulatory knowledge helps them to take strategic decision effectively. Hence, this has resulted in creation of regulatory department with certified regulatory affairs professionals. Therefore, it help companies to meet these requirements with ease.

About regulatory affairs job>> Learn here

Do this course provides training on medical devices regulatory affairs?

No. This course covers drug regulatory affairs. But this course does not cover medical device regulatory affairs. However, we have drug medical devices regulatory affairs, in a single course. >> Click here to Learn more.

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 6Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
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 17Complete Response Letter | Key understanding | Management and Action Plan
Lecture 18Handling of orange book
Lecture 19Purple Book: Significance | Searching | Assignments
Lecture 20Review on Drug Discovery and Development 
Lecture 21Understanding on Clinical Trials  and Clinical Research 
Lecture 22Clinical Trial Protocol Writing
Lecture 23Ethics in Clinical Research
Lecture 24Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 25FDA Forms and How to fill the resources
Lecture 26Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 2 Clinical Trial / Clinical Research
Lecture 27Orientation to European Countries and National Regulatory Bodies
Lecture 28EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 29Overview of EU Regulation 
Lecture 30EMA and EMA Authorisation Process
Lecture 31EU MA Application Types and Strategic Planning
Lecture 32EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 33EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 34Validity 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 35Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 36EU Orphan Medicinal Products Regulation
Lecture 37EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 38Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 39Summary of Product Characteristics 
Lecture 40Compassionate Use
Lecture 41MHRA - UK Regulation 
Lecture 42The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 43Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 44EU Prime Designation 
Lecture 45Accelerated assessment by EMEA
Lecture 46EU Adaptive Pathway
Lecture 47European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 48SPOR  - Concept of Master Data Management  
Section 3 Regulatory Strategic Management and planning
Lecture 49Regulatory Strategies in different phases of Clinical Trial
Lecture 50Advance study on Para IV Filing
Lecture 51Para IV Notice
Lecture 52Evergreening - Patent Life Extension Strategies
Lecture 53Pay For Delay Strategy
Lecture 54REMS Strategic Planning
Lecture 55Compulsory Licensing
Lecture 56Licensing & Technology Transfer
Lecture 57In-Licensing Vs. Outlicensing
Lecture 58LOE Strategies for Innovator Brands with case study
Lecture 59Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 60Drug Re-purposing
Lecture 61Practical Queries on different USFDA application and Filing
Lecture 62Publication Management from Regulatory perspective
Lecture 63Juxtapid Case Study
Lecture 64New Indication Approval Process and Promotion
Lecture 65OTC Switch
Section 4Good Manufacturing Practices
Lecture 66Certification Pharmaceutical Companies / Plants
Lecture 67Premises & Plant Layout Designing
Lecture 68Sanitation and Hygiene
Lecture 69Equipment
Lecture 70Production Modules
Lecture 71GMP Documentation
Lecture 72Quality Control
Lecture 73Handling of Product Complaint
Lecture 74GMP Storage
Lecture 75ISO and ISO Audits
Lecture 76Pharmaceutical SOPs
Lecture 77SOP Automation
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 78Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 79CMC Dossier & Compliance Management
Lecture 80Electronic Common Technical Document (ECTD)
Lecture 81Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 82Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 83Key Consideration for Drug Master File Preparation and Submission 
Lecture 84Practical Understanding on Drug Master File Preparation and Submission
Lecture 85Site Master File - Detailed Understanding 
Lecture 86DMF Completeness Assessment
Lecture 87Drug Master File - Fees
Lecture 88Drug Master File - Global Perspective [Across Different Regions]
Lecture 89Importance of effective dossier management
Lecture 90Common deficiencies in CTD submission dossier
Lecture 91Certificate of Analysis
Lecture 92Detailed Understanding on ANDA Fees
Lecture 93Prior Approval Submission 
Lecture 94Detailed Understanding on ANDA Fees
Lecture 95Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 96NCE Vs. 505b2 application - Case Based Learning 
Lecture 97FTF - 180 Days Exclusivity - Case Based Learning
Lecture 98Classic case study of the 505b2 filing : Case Based Learning
Lecture 99Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 100Discussion on 85 common deficiency in CTD submission dossier
Lecture 101Asean Common Technical Document (ACTD) 
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 102Data Integrity issues in Pharmaceutical Industry
Lecture 103Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 104Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity