- LASTUPDATED AUGUST 2022 -

Welcome to the only up-to-date complete edition of the ICH-GCP course!

This course offers the first professional, fundamental on-line ICH-GCP (R2) course for Investigators, Study Coordinators, Sponsors, Clinical Project Managers, Monitors and any other Clinical Study staff requiring knowledge in GCP for a successful execution your clinical trials. This ICH-GCP course also presents elements of ICH-GCP (R3) as they become available currently under revision by ICH.

This ICH-GCP course meets the Minimum Criteria for ICH E6 (R2) GCP Investigator and Site Personnel Training that TransCelerate has identified as necessary to enable mutual recognition of GCP training. It provides full lifetime access to GCP Revison 2, and all subsequent Revisions of the GCP by the ICH. The course is updated every month to present the most up-to-date relevant information.

My name is Dr. Vincent Baeyens PhD, Ihave more than 20 years of experience in running Clinical Trials (phase 1 to 4) in Global and mid-size Pharma, and Biotech settings. I have worked with most of the Global as well as several niche CROs andI am also an expert inCRO Management and Oversight.

In this course, you will be able to understand based on my experience the key ICH-GCPrequirements to design, conduct, record and report clinical trials in humans from A to Z. We will review the role and responsibilities of the key stakeholders and the structure of the essentials documents.

This course will provide you with a strong foundation to prepare for successful regulatory ICH-GCP inspections and audits.

To do so, I will lead you step-by-step through the ICH-GCPE6, and you will be able to understand:

• What is GCP and why GCP is important in clinical research

• The link between the Declaration of Helsinki and current GCP

• The definition of the key definitions of terms and concepts used in clinical research, including stakeholders involved and essential documents

• The ICH-GCP Principles and practical advices to apply them in your clinical trials

• The responsibilities of ethics committees, its composition, function, operational aspects and obligations

• The detailed responsibilities of the Investigator throughout the trial, including his/her qualifications, compliance to protocol, communication with Ethics Committees, safety reporting, and final reporting

• How to write an adequate Protocol / protocol amendment and rationale for its structure

• The What, the Why and the How for an effective writing of the Investigator's Brochure

• The purpose of Essential Documents in clinical research: How and Where to file them in the Trial Master File (TMF)

• The common ICH-GCP audit and inspection findings in clinical trials and how to avoid them

  
  

Iwill illustrate the GCP concepts with several practical tips & tricks , so that you will be able to apply ICH-GCP to your daily practice from Day 1!

Several Quiz are proposed to test your knowledge along your journey. A final Quiz at the end of the course will consolidate your knowledge.

Feel free to look at the content of the course to know more and contact me any time if you have any questions!

After the course, spend 1 hour with the EXPERT to answer ALLthe questions that you would have!! All you have to do is to send me an e-mail with your questions and contact details, and I will set up a call with you.

I am of course available personally during the course as well to answer your questions or comments!

I am looking forward to seeing you inside the course!

Sincerely,

Vincent