Presenting the real GCP handbook: Build solid knowledge of GCP by learning the rules exactly as they appear in the official text

Why Should You Attend:
When conducting a Clinical Trial, GCP is the only recognized code of practice and needs to be followed meticulously. Following patient enrollment, knowledge of GCP is taken for granted by auditors and inspectors alike. Study Sponsors, include GCP training as part of investigator meetings, prestudy and initiation visits and their own employee training programs. A number of third party organizations offer relevant seminars. Training certificates are being issued to prove GCP competency. Inspectors review vigorously sponsor and site documentation to ensure adequate training.

Yet, most presentations on GCP rely more on the presenters' experiences and interpretations of the GCP guidelines than on the actual, official text.

It is highly probable that you have been trained on GCP through hands on experience, seminars on what to watch out for, webinars on audit findings, relevant organization SOPs than from the official GCP handbook!

This fact in most cases creates a knowledge gap.

This webinar will attempt to fill this gap by analyzing clinical trial conduct via the GCP handbook itself.

It is addressed to those who wish to build a solid knowledge of the rules governing clinical trials, those that wish to be able to start developing their own judgment on what is critically important and what's not. This can only be done when one gets accustomed to the structure and content of the actual guidelines, when one becomes familiar with the actual wording therein.

The version of the ICH GCP guideline that will be analyzed is ICH/135/95, July 2002, from the European Medicines Agency NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE, CPMP/ICH/135/95, July 2002.

Areas Covered in the Seminar:

• Sponsor responsibilities & tasks when running clinical trials (incl. CRA responsibilities).
• Investigator responsibilities & tasks when running clinical trials.
• Exploring the structure of the GCP handbook.
• Importance of Good Clinical Practice.
• Essential documents in Clinical trials.
• Definition of Adverse and Serious adverse events.
• ICH guidelines on the Informed consent process.
• How inspectors use the handbook .
• Definition of ranking of audit findings: minor-major-critical.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in: Research Facilities, Pharmaceutical & Biotechnology industry and CROs conducting Clinical Trials including:

• Investigators, site coordinators and subinvestigators
• Clinical Research Associates
• Clinical Operations Staff
• Managers in Clinical Development and Project Leaders
• Regulatory Compliance Associates and Managers
• Quality Assurance Managers and auditors

Instructor Profile:
Leonidas Lambrinidis, BSc Biochemistry, MSc Biochemical Engineering, MBA. 10 years in clinical research. Held various positions in the industry from CRA to Associate director of project management. Worked both in the Pharmaceutical industry and CROs. Experience in sponsor, FDA and EMA inspections. Conducted both internal and external trainings.