BUILD A CAREER AS A CLINICAL RESEARCH INVESTIGATOR – FDA AND EMA REGULATIONS
Course Objective
This webinar was developed especially for those who are interested to learn more about one of the biggest, recession proof industries worldwide. Professionals seeking for change of career, or exploring the options to learn the basics of the pharmaceutical industry. 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 thetrainer’s guidance. Access to the recorded version of the webinar for a period of 6 months.
“BECOMING A CLINICAL RESEARCH INVESTIGATOR” WEBINAR
Trainer Professional Summary:
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)
