Basic GCP and Clinical Research Training for Newcomers to the Industry (Including Sales Teams)
Duration: 60 Minutes
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.
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Download AgendaThere 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
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
- Business Development
- Sales
- Study Coordinator
- Investigator
- Researchers
- Vendor staff supporting the clinical trials industry
How it works
Live Session - How it works
- Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
- The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
- Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
- Login to the audio conference on the scheduled date and time
- Get answers to your queries through interactive Q&A sessions via chat at the end of the session
- Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
- Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
- Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
- Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
- Please click on the link to access the Recorded Session
- Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
- Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
- Please share your valuable Feedback at the end of the session
Instructor Profile:
Meryl is a consultant to the biopharma industry in the areas of quality assurance, quality and vendor management, outsourcing, and business process optimization. Previously, she was the VP of QA and Business Excellence for SynteractHCR, a mid-sized global CRO, where she participated in company integration activities, global harmonization, and enhancement of quality processes. Meryl has also served as the Director of Strategic Outsourcing for Teva Pharmaceuticals, Bristol Myers Squibb and Amgen; for Teva and BMS, she originated these departments. Meryl has worked for several central laboratories, including LabCorp, MDS Pharma, Quest Diagnostics and ACM, in functions including Project Management, Operations, Quality, client relationship management, global harmonization, and Biorepository management. During her 19 year tenure at Bristol Myers Squibb, she was instrumental in the conceptualization, implementation, growth, and marketing of the BMS Clinical Laboratory, in support of the phase I unit as well as Phase II-IV trials.
Meryl holds a BS in Medical Technology from Rutgers University and an MBA from Fairleigh Dickinson University.
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Meryl is a consultant to the biopharma industry in the areas of quality assurance, quality and vendor management, outsourcing, and business process optimization. Previously, she was the VP of QA and Business Excellence for SynteractHCR, a mid-sized global CRO, where she participated in company integration activities, global harmonization, and enhancement of quality processes. Meryl has also served as the Director of Strategic Outsourcing for Teva Pharmaceuticals, Bristol Myers Squibb and Amgen; for Teva and BMS, she originated these departments. Meryl has worked for several central laboratories, including LabCorp, MDS Pharma, Quest Diagnostics and ACM, in functions including Project Management, Operations, Quality, client relationship management, global harmonization, and Biorepository management. During her 19 year tenure at Bristol Myers Squibb, she was instrumental in the conceptualization, implementation, growth, and marketing of the BMS Clinical Laboratory, in support of the phase I unit as well as Phase II-IV trials.
Meryl holds a BS in Medical Technology from Rutgers University and an MBA from Fairleigh Dickinson University.
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