Regulatory Affairs: Cmc

Chemistry, Manufacturing and Controls. From RA History to Submission.

What you'll learn
Identify the CMC information required for submissions to support clinical studies and marketing applications
Discuss the role of ICH and individual national/regional guidances that should be referenced when preparing or updating a CMC section
Identify CMC changes that require agency notification
Be an expert in the main CMC-guidances
Requirements
Previous regulatory affairs, quality, clinical, R&D experience is a plus, but not strictly required
Description
This course provides an overview of the Chemistry, Manufacturing and Controls (CMC) section of dossiers and discusses CMC information necessary to support product applications, identifies CMC changes that are required for amendments, and provides an understanding of the CMC information needed to support marketing applications and postapproval submissions, including the use of Drug Master Files (DMFs) and CMC for IMPD. The best choice for future certification and career promotion. In general, despite regional differences, most health authorities expect an increasing amount of information and a depth of technical knowledge to be provided in clinical trial applications, CTD/eCTD dossiers. Regulatory requirements for CMC information, history of CMC, guidance, and tips are provided within the scope of this course. Creator of this course - D. Ladanovska (RA Consultant, Head of RA)Speaker of this course - Liyonish (US singer, actress, speaker) Upon completion of this course, you will be able to:Identify the CMC information required for submissions to support clinical studies and marketing applications;Discuss the role of ICH and individual national/regional guidances that should be referenced when preparing or updating a CMC section;Identify CMC changes that require agency notification;Explain different types of postapproval submissions;Describe the use of Drug Master Files (DMFs);Use tips for the IMPD Quality part;Be an expert in the main CMC-guidances. With a calm invited narrator's voice in this course, be ready to expand your knowledge and be prepared for future career challenges and winnings. Let's go!

Overview

Section 1: Introduction

Lecture 1 Greetings

Lecture 2 Introduction

Section 2: What is CMC?

Lecture 3 What is CMC?

Lecture 4 Application

Section 3: Regulatory History of CMC

Lecture 5 Regulatory History of CMC (1862)

Lecture 6 1883 - 1906

Lecture 7 1938

Section 4: EU Legislation

Lecture 8 EU Legislation

Section 5: ICH

Lecture 9 ICH

Section 6: Pharmacopeial Standards

Lecture 10 EU

Lecture 11 USA and Japan

Section 7: CMC Within A Drug Application

Lecture 12 CMC Within A Drug Application

Section 8: CMC Module 3

Lecture 13 CMC Module 3

Lecture 14 Dossier and Quality

Lecture 15 GMP guidelines

Lecture 16 QMS

Section 9: Up-to-date CMC

Lecture 17 Up-to-date CMC

Section 10: Procedure of Changes

Lecture 18 Procedure of Changes

Section 11: CMC-Guidances

Lecture 19 CMC-Guidances

Lecture 20 25 Tips for IMPD

Lecture 21 CMC planning for biologics application

Section 12: Summary of the course

Lecture 22 Importance

Lecture 23 Planning Strategies

Regulatory Affairs Officer,Regulatory Affairs Associate,Regulatory Affairs Specialist,Regulatory Affairs Manager,Quality Control Manager,Head of Regulatory Affairs,Regulatory Writer