• views: 208
• date: 7 September 2023
• posted by: voska89

What you'll 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.
Requirements
Clinical Research Organizations staff, students
Beginners
Description
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.
Overview
Section 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
Section 2: ICH-GCP Principles, Importance, Link
Lecture 10 ICH GCP Preview
Lecture 11 ICH-GCP, Principles, Importance, Link
Section 3: ICH GCP E6 R2
Lecture 12 ICH GCP E6 R2 Guidelines
Lecture 13 Clause 2.1-2.13
Lecture 14 Investigator Clause 4.1-4.3
Lecture 15 Clause 4.4-4.7
Lecture 16 Clause 4.8-4.13
Lecture 17 Sponsor Clause 5.0-5.10
Lecture 18 Sponsor Clause 5.11-5.23
Section 4: Extra Lecture
Lecture 19 Quality Module 3.2 P.2
Clinical Research Organizations staff, students,Beginners
Homepage

https://www.udemy.com/course/ich-gcpgood-clinical-practicequizguidelinebonus-lecture/

   
   
   

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