Basic GCP and Clinical Research Training for Newcomers 2015

Basic GCP and Clinical Research Training for Newcomers to the Industry (Including Sales Teams) Instructor: Meryl Wiernik Product ID: 500973 Description This course will review the phases of clinical research, and will review the basics of Good Clinical Practice (GCP), and will be geared towards non-clinical staff who joined the industry, as well as sales personnel either within or supporting the biopharma industry. There are many newcomers to the biopharmaceutical industry who certainly have transferable skills, however, they do not have a clear understanding of clinical research and how their new position fits into the drug development cycle. Further, a basic knowledge of Good Clinical Practice is essential for most position within biopharma, irrespective of the job function. Areas Covered Introduction to the clinical trials industry Drug development process Regulations and FDA guidance Good Clinical Practices Principles of ICH-GCP Ethics and quality in clinical trials Good documentation practices Quality System Why Should you Attend A basic knowledge of GCP and the drug development process is crucial for anyone working within the pharmaceutical industry, as well as for sales staff who are newly selling to this industry. Objectives of the Presentation Clinical Trials industry introduction Understanding the drug development process Understanding Good Clinical Practices Elements of a quality system Importance of the regulations Understanding ethics in clinical trials Who can Benefit Business Development Sales Study Coordinator Investigator Researchers Vendor staff supporting the clinical trials industry