Regulatory Affairs: CMC

Regulatory Affairs: CMC, available at $44.99, has an average rating of 3.45, with 23 lectures, 3 quizzes, based on 79 reviews, and has 243 subscribers.

You will learn about 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 This course is ideal for individuals who are Regulatory Affairs Officer or Regulatory Affairs Associate or Regulatory Affairs Specialist or Regulatory Affairs Manager or Quality Control Manager or Head of Regulatory Affairs or Regulatory Writer It is particularly useful for Regulatory Affairs Officer or Regulatory Affairs Associate or Regulatory Affairs Specialist or Regulatory Affairs Manager or Quality Control Manager or Head of Regulatory Affairs or Regulatory Writer.

Enroll now: Regulatory Affairs: CMC

Summary

Title: Regulatory Affairs: CMC

Price: $44.99

Average Rating: 3.45

Number of Lectures: 23

Number of Quizzes: 3

Number of Published Lectures: 23

Number of Published Quizzes: 3

Number of Curriculum Items: 26

Number of Published Curriculum Objects: 26

Original Price: $22.99

Quality Status: approved

Status: Live

What You Will 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

Who Should Attend

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

Target Audiences

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

This course providesan 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!

Course Curriculum

Chapter 1: Introduction

Lecture 1: Greetings

Lecture 2: Introduction

Chapter 2: What is CMC?

Lecture 1: What is CMC?

Lecture 2: Application

Chapter 3: Regulatory History of CMC

Lecture 1: Regulatory History of CMC (1862)

Lecture 2: 1883 – 1906

Lecture 3: 1938

Chapter 4: EU Legislation

Lecture 1: EU Legislation

Chapter 5: ICH

Lecture 1: ICH

Chapter 6: Pharmacopeial Standards

Lecture 1: EU

Lecture 2: USA and Japan

Chapter 7: CMC Within A Drug Application

Lecture 1: CMC Within A Drug Application

Chapter 8: CMC Module 3

Lecture 1: CMC Module 3

Lecture 2: Dossier and Quality

Lecture 3: GMP guidelines

Lecture 4: QMS

Chapter 9: Up-to-date CMC

Lecture 1: Up-to-date CMC

Chapter 10: Procedure of Changes

Lecture 1: Procedure of Changes

Chapter 11: CMC-Guidances

Lecture 1: CMC-Guidances

Lecture 2: 25 Tips for IMPD

Lecture 3: CMC planning for biologics application

Chapter 12: Summary of the course

Lecture 1: Importance

Lecture 2: Planning Strategies

Instructors

Dasha Ladanovska
Clinical Trial Regulatory Management at IQVIA

Rating Distribution

1 stars: 9 votes
2 stars: 12 votes
3 stars: 21 votes
4 stars: 19 votes
5 stars: 18 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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