Trainer Profile:
The lecturer is a professional trainer, auditor, and consultant with extensive international experience related to clinical trials. Here is some of his background:
- Active participation in FDA and EMA inspections and pre-inspection activities in GCP, GLP and GMP areas;
- Extensive working experience in highly regulated environment of GCP, GLP and GMP;
- Experience in I-IV phases of clinical trials, ISO 9001 and Computer Systems Validation
- Since July 2009 conducted about 25 vendors and contractors audits including QClaboratories, Blood Sample Laboratories, licensing candidates, PK laboratories, safety and clinical laboratories, raw material manufacturers, IMP storage Facilities, IT suppliers;
- Since March 2008 conducted 40 audits in GLP area (Vaccines, formulated proteins, monoclonal antibodies).
- Since July 2009 conducted about 40 external audits in GCP area including: Neurology,Pulmunology, Oncology, Cardiology, Primary Care, Medical Devices and Biologics (Vaccines, monoclonal antibodies)
Agenda:
- Brief history of regulations within clinical trials
- ICH GCP and the responsibilities of the investigator
- ICH GCP versus EU Clinical Trial Directive
- FDA Specifics
- The clinical trial as opposed to regular medical practice
- FDA Specifics
- The clinical trial as opposed to regular medical practice
- Informed consent and patient recruitment issues
- Safety reporting
- Efficient study management, documentation & data recording
- How to attract study sponsors
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Course Duration:
Approximately 2 hours and 30 minutes
Fee Structure:
Regular fee: 125 USD
First 5 signed delegates: 99 USD
Date of Session:
To be confirmed
For this price you will get:
- Upon completion of the course each participant will be provided with a certificate of attendance
- A workshop at the end of the webinar which will give you time to ask questions and solve real-life practical case studies under the trainer`s guidance
- Discounts for future online events
