Managing Mid-Study Changes in Clinical Studies: Best Practices

This clinical trial compliance webinar will discuss common challenges and practical suggestions for mid-study changes. It will use a case-study approach to explain the best practices for mid-study changes.

Who will Benefit:

This webinar will provide valuable information to

• Sponsors for clinical trials
• Investigators and sites participating in clinical trials
• Clinical trial personnel such as project managers, CRAs, clinical coordinators
• IRB personnel
• Regulatory Vice Presidents, Directors and Managers at sponsors
• Attorneys – In-house or Outside Counsel

Instructor Profile:

Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.