InstructorRoyed Training
TypeOnline Course
Price$550 USD / 25500 INR.
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pg certification in drug regulatory affairs

Introduction

Course Type

Course Duration

Eligibility

Certification

Features

Related Courses

About RA

This online drug regulatory affairs course provides understanding of drug regulation, drug registration process and strategic planning. Drug Regulatory Affairs Course

This PG Certification is designed to create effective Regulatory Affairs Manager for Pharmaceutical Industry. This Drug Regulatory Affairs training course gives practical knowledge and real life job simulation. Course focus on how regulatory professionals work in company and understanding of key responsibilities and job functions.

In this online self-paced modules, participant will be understanding about the drug development to commercialization process in detail. 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. Course covers fundamental to advance learning on drug development, regulation, registration and strategic management process.

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. Major objective of the regulatory department to maintain safety and efficacy of the drugs and biopharmaceutical molecules. And 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. 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 !
Section 3 Regulatory Strategic Management and planning
Lecture 22Regulatory Strategies in different phases of Clinical Trial
Lecture 23Advance study on Para IV Filing
Lecture 24Para IV Notice
Lecture 25Evergreening - Patent Life Extension Strategies
Lecture 26Pay For Delay Strategy
Lecture 27REMS Strategic Planning
Lecture 28Compulsory Licensing
Lecture 29Licensing & Technology Transfer
Lecture 30In-Licensing Vs. Outlicensing
Lecture 31LOE Strategies for Innovator Brands with case study
Lecture 32Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 33Drug Re-purposing
Lecture 34Practical Queries on different USFDA application and Filing
Lecture 35Publication Management from Regulatory perspective
Lecture 36Juxtapid Case Study
Lecture 37New Indication Approval Process and Promotion
Lecture 38OTC Switch
Section 4Good Manufacturing Practices
Lecture 39Introduction to Good Manufacturing Practices
Lecture 40Premises & Plant Layout Designing
Lecture 41Sanitation and Hygiene
Lecture 42Equipment
Lecture 43Production Modules
Lecture 44GMP Documentation
Lecture 45Quality Control
Lecture 46Handling of Product Complaint
Lecture 47GMP Storage
Lecture 48ISO and ISO Audits
Lecture 49Pharmaceutical SOPs
Lecture 50SOP Automation
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 51Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 52CMC Dossier & Compliance Management
Lecture 53Electronic Common Technical Document (ECTD)
Lecture 54Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 55Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 56Key Consideration for Drug Master File Preparation and Submission 
Lecture 57Practical Understanding on Drug Master File Preparation and Submission
Lecture 58Site Master File - Detailed Understanding 
Lecture 59DMF Completeness Assessment
Lecture 60Drug Master File - Fees
Lecture 61Drug Master File - Global Perspective [Across Different Regions]
Lecture 62Importance of effective dossier management
Lecture 63Common deficiencies in CTD submission dossier
Lecture 64Certificate of Analysis
Lecture 65Detailed Understanding on ANDA Fees
Lecture 66Prior Approval Submission 
Lecture 67Detailed Understanding on ANDA Fees
Lecture 68Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 69NCE Vs. 505b2 application - Case Based Learning 
Lecture 70FTF - 180 Days Exclusivity - Case Based Learning
Lecture 71Classic case study of the 505b2 filing : Case Based Learning
Lecture 72Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 73Discussion on 85 common deficiency in CTD submission dossier
Lecture 74Asean Common Technical Document (ACTD) 
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 75Data Integrity issues in Pharmaceutical Industry
Lecture 76Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 77Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity