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An Overview of Recent Risk-based Monitoring Guidance from the FDA
$249.00
Joy Frestedt
Conducting Medical Device Studies in the UK
$249.00
Janette Benaddi
Early Development Considerations for Inhalation Drug Products
$249.00
Nahed Mohsen
Establishing Effective and FDA-Compliant Good Clinical Practices (GCP)
$249.00
David Lim
FDA Update – Responding to Unsolicited Requests for Off-Label Information
$249.00
Marian Lee & Beverly Lorell
Food Industry Update – Responding to an FDA Form 483
$249.00
Lisa Capote
Improving Study Feasibility- Why Sites Fail and How to Avoid It
$249.00
Nikki Christison
Industry Update – China's Evolving Medical Device Regulations
$249.00
Seth Goldenberg
Measuring and Improving the Readability of Medical Device User Information
$249.00
Cynthia M Shaler
Medical Device Software – Regulatory Requirements and Issues
$249.00
Neil Armstrong
Meeting the Linguistic Requirements for EMA Submissions
$249.00
Anabel Pérez
Monitoring Device Trials: Findings, Recommendations, Corrective Action Plans
$249.00
JoAnn Tyson
New Paradigm – Drug Development Partnerships and Their Impact on Quality
$249.00
Pete Harpum
Patient Recruitment: How It's Broken and Five Ways to Fix It
$249.00
Sherry Reuter
Post-market Design Changes – What FDA is Saying Now
$249.00
David Rothkopf
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