This Clinical Trials and GCP session will describe the principles of Good Clinical Practice including drug development process and Specifics of GCP and quality as related to central laboratory work.
Why Should You Attend:
All personnel involved in clinical trials, whether working directly in a clinical environment within the pharmaceutical or biotech community, or serving this community as a service provider, are required to understand the standards regulating this industry, including GCP. GCP regulations were created to ensure both ethical and scientific quality when conducting clinical trials, which are investigations involving human subjects that are required to bring new drugs to market. This webinar will provide an overview and definition of Clinical Research and Clinical Trials, regulatory requirements, and Good Clinical Practices. This course will serve as training material for new entrants into this industry, or as a refresher course to those who have not attended a recent review session.
Areas Covered in the Seminar:
This Session will describe the principles of Good Clinical Practice, including:
- An overview of the drug development process.
- Description of the principles of ICH-GCP.
- Regulatory standards and requirements.
- A description of all parties involved in the drug development process.
- Overview of good clinical practices.
- Construction of a clinical protocol.
- Correct documentation practices.
- Specifics of GCP and quality as related to central laboratory work.
Who Will Benefit:
This webinar will provide valuable educational information to all management teams in food service industry.
- This webinar will provide required training for personnel involved in clinical trials, both within the pharma and biotech industries, as well as service providers supporting those industries.
- New entrants into the clinical industry require an understanding of the regulations and of GCP, and retraining should occur periodically, often yearly for service providers.
Instructor Profile:
Meryl Wiernik, has 25+ years of experience in the clinical trials industry. She has led global Project Management, Operations, and Quality Assurance teams. At Quest Diagnostics Clinical Trials Meryl was the Global Director, Business Systems Integration, where she was responsible for the design and deployment of globally integrated systems, applications and processes essential for delivery of services to the company’s clients located throughout the pharmaceutical, biotechnology and medical devices industries. Prior to joining Quest, Meryl led Clinical Strategic Sourcing groups for Amgen, and Bristol Myers Squibb, responsible for outsourcing and supplier relationship management.
During her 19 yr tenure at Bristol-Myers Squibb, she was instrumental in the conceptualization, implementation, growth, and marketing of the BMS Clinical Laboratory. Additionally, Meryl has served as a consultant for the laboratory, specimen storage, and clinical logistics industries.
Meryl holds a BS in Biology/Medical Technology from Rutgers University and an MBA from Fairleigh Dickinson University.
