3-hr Virtual Seminar: Annual ICH GCP Refresher Course

Why Should You Attend:

It is required that all healthcare professionals involved in clinical research must have documentation of current ICH GCP training. It is also required that that staff involved in clinical research update their ICH GCP training on a yearly basis. This training will help you fulfill this requirement.

This 3-hr virtual seminar is designed to provide a comprehensive training on ICH GCP guidelines. It is designed to offer documentation of comprehensive ICH GCP training required by regulatory agencies and sponsors. Participants will learn why ICH GCP has been adopted worldwide as the standard for ethical research practices and how to implement ICH GCP in their daily processes.

Areas Covered in the Webinar:

The webinar will include the following critical information you will need:

1. Background information on the need for standardized GCP guidelines for the clinical research industry.
2. Coverage of ICH requirements for the Investigator.
3. Coverage of ICH requirements for the Sponsor.
4. Coverage of ICH requirements for IRBs.
5. Subject rights.
6. Adverse Event and Serious Adverse Event reporting.
7. Essential document requirements.
8. Document retention requirements.
9. Best practices and fraud.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel/ companies in the clinical research industry. The employees who will benefit most include:

• Principal Investigators
• Research Nurses
• Study Coordinators
• Site Regulatory Personnel
• Clinical Research Site Administrators
• Sponsor site selection personnel
• CRAs
• Quality Assurance
• Documentation professionals both at the site and sponsor companies
• Healthcare professionals needing to acquire documentation of current ICH GCP training.

Instructor Profile:

Christine Hegi, RN, CCRP is the Founder and President of Hegi Research Corp. headquartered in Calgary, AB, Canada, which is a group of Independent CRAs offering clinical research consulting, auditing, site management and monitoring services to the pharmaceutical industry. Ms. Hegi has clinical research experience as the Global Project Manager for several large, multinational studies and has over 20 years of extensive experience in all phases of drug and device development.

Christine is the author of SOPs for Clinical Research Sites© which is a comprehensive set of Standard Operating Procedures available for purchase. These SOPs are unique in that they are designed to be customized by the site and to be utilized as a training tool for site staff.

Ms Hegi has authored and instructed CRA training courses for some of the major pharmaceutical companies as well as small organizations. She has taught multiple courses in SOP development and utilization. Multiple academic organizations have contracted her services for the presentation of ICH GCP and other research related courses. She has presented multiple times at professional conferences. Her previous experience as an Emergency Nurse, Study Coordinator, CRA and Director of Clinical Affairs bring both site and industry perspectives to her teaching.

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