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Ensuring Compliance in Global Clinical Trials
Bruce Wagman
Vice President
Regulatory
& QA Services
Covance Inc.
Recordings
- US$249
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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 will address:
- 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
Speaker
biography:
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
This
audio conference is rated General Interest.
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