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Ensuring Compliance in Global Clinical Trials: A Regulatory Perspective
April 24th, 2008
Bruce Wagman
Vice President Regulatory & QA Services
Covance
Download this Audio Conference (MP3)
An increasingly intense competitive environment and the shrinking pools of treatment populations in traditional markets has forced drug companies to 'go global' and approach emerging markets to place research and secure enrollment. But how do you 'go global' without sacrificing consistency and quality in clinical trials? This audio conference will discuss the unique challenges posed by international clinical trials, and provide a regulatory expert view of how to overcome these challenges and ensure compliance across various countries and geographic regions.
This audio conference addressed:
- Factors that influence compliance at investigative sites including local standards of care, training, site communication and motivation
- Evaluating protocols to predict elements likely to become a source of non-compliance
- Practical tools and approaches to proactively assure investigator compliance
- Additional measures needed to accommodate new regulatory requirements, processes and technologies
About the speaker:
Bruce Wagman is Vice President, Regulatory and Quality Assurance Services for Covance. In his role as the Regulatory Affairs officer for Covance Late Stage Development Services, he helps clients develop regulatory strategy and submissions. He also provides leadership and strategic direction for Covance's worldwide Regulatory Affairs and Regulatory Compliance operations. He is a faculty member of the Drug Information Association, and in 2003 was presented with the DIA's Outstanding Service Award. He has provided drug development training for pharmaceutical professionals and government officials throughout the world.
Prior to joining Covance, he held positions of increasing responsibility at various companies including Omnicare Clinical Research, MDS Pharma, Bristol-Myers Squibb, and Corning-PACT. He also served in Operation Desert Storm as a Captain in the United States Air Force Nurse Corps. Bruce received a Bachelor of Science degree in Nursing from Syracuse University and an MBA from Drexel University in Philadelphia. He has been involved in the healthcare industry for twenty-six years, with eight years of experience in clinical patient care and eighteen years in the pharmaceutical industry.
Who should attend?
- Regulatory Affairs
- Quality Assurance
- Operational Managers
- Clinical Managers
- Research & Development
Download this Audio Conference (MP3) |
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