ICH-GCP:Good Clinical Practice(QUIZ+Extra Lecture 2023-24

ICH-GCP:Good Clinical Practice(QUIZ+Extra Lecture 2023-24, available at $19.99, has an average rating of 3.5, with 19 lectures, 3 quizzes, based on 2 reviews, and has 4 subscribers.

You will learn about In the ICH GCP (International Council for Harmonisation – Good Clinical Practice) course, students will learn the essential principles and guidelines for conducting clinical trials ethically and ensuring the safety and well-being of human participants. They will gain a comprehensive understanding of the regulatory requirements, documentation, and standard operating procedures involved in the entire clinical tr The course will cover topics like trial design, informed consent, data collection, monitoring, adverse event reporting, and quality assurance. By completing the course, students will be equipped with the knowledge and skills necessary to adhere to GCP standards contribute to successful and compliant clinical research. This course is ideal for individuals who are Clinical Research Organizations staff, students or Beginners It is particularly useful for Clinical Research Organizations staff, students or Beginners.

Enroll now: ICH-GCP:Good Clinical Practice(QUIZ+Extra Lecture 2023-24

Summary

Title: ICH-GCP:Good Clinical Practice(QUIZ+Extra Lecture 2023-24

Price: $19.99

Average Rating: 3.5

Number of Lectures: 19

Number of Quizzes: 3

Number of Published Lectures: 19

Number of Published Quizzes: 3

Number of Curriculum Items: 22

Number of Published Curriculum Objects: 22

Original Price: $29.99

Quality Status: approved

Status: Live

What You Will Learn

In the ICH GCP (International Council for Harmonisation – Good Clinical Practice) course, students will learn the essential principles and guidelines
for conducting clinical trials ethically and ensuring the safety and well-being of human participants.
They will gain a comprehensive understanding of the regulatory requirements, documentation, and standard operating procedures involved in the entire clinical tr
The course will cover topics like trial design, informed consent, data collection, monitoring, adverse event reporting, and quality assurance.
By completing the course, students will be equipped with the knowledge and skills necessary to adhere to GCP standards
contribute to successful and compliant clinical research.

Who Should Attend

Clinical Research Organizations staff, students
Beginners

Target Audiences

Clinical Research Organizations staff, students
Beginners

Embark on a transformative journey through our comprehensive online course, “Mastering ICH-GCP E6 R2: Good Clinical Practice for Clinical Research.” This meticulously crafted program is your gateway to becoming a proficient and certified expert in the intricacies of conducting ethical and high-quality clinical trials.

Designed for both novices and seasoned professionals, this course delves deep into the International Conference on Harmonization (ICH) guidelines, specifically E6 R2, elucidating every facet of Good Clinical Practice (GCP) in the realm of clinical research. With a dynamic blend of engaging multimedia content, interactive modules, and real-world case studies, you’ll gain an in-depth understanding of the core principles of ICH-GCP E6 R2, ensuring the highest standards of participant safety, data integrity, and ethical conduct.

Our industry-renowned instructors, each a luminary in their respective fields, will guide you through essential topics such as obtaining informed consent, protocol adherence, adverse event reporting, and investigator responsibilities. Additionally, you’ll explore the critical role of Institutional Review Boards (IRBs) and gain practical insights into effective monitoring techniques.

Upon successful completion, you’ll not only be armed with a comprehensive knowledge of ICH-GCP E6 R2 but also earn a prestigious certification that solidifies your expertise and enhances your career prospects in the dynamic landscape of clinical research. Join us today and unlock the doors to excellence in Good Clinical Practice. Your journey toward mastering ICH-GCP E6 R2 starts here.

Course Curriculum

Chapter 1: Introduction

Lecture 1: Introduction

Lecture 2: Pharma Regulatory Jargons

Lecture 3: DMF

Lecture 4: Audit

Lecture 5: Regulatory Compliance and Requirements

Lecture 6: Regulatory Regime India, US and EU

Lecture 7: IPR, Copyrights and Patents

Lecture 8: IPR in India

Lecture 9: IRB or IEC

Chapter 2: ICH-GCP Principles, Importance, Link

Lecture 1: ICH GCP Preview

Lecture 2: ICH-GCP, Principles, Importance, Link

Chapter 3: ICH GCP E6 R2

Lecture 1: ICH GCP E6 R2 Guidelines

Lecture 2: Clause 2.1-2.13

Lecture 3: Investigator Clause 4.1-4.3

Lecture 4: Clause 4.4-4.7

Lecture 5: Clause 4.8-4.13

Lecture 6: Sponsor Clause 5.0-5.10

Lecture 7: Sponsor Clause 5.11-5.23

Chapter 4: Extra Lecture

Lecture 1: Quality Module 3.2 P.2

Instructors

Monica Sharma
Educator: Biotechnology/Biology

Rating Distribution

1 stars: 0 votes
2 stars: 0 votes
3 stars: 1 votes
4 stars: 1 votes
5 stars: 0 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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