Marriott Bethesda North Hotel and Conference Center
5701 Marinelli Road, Bethesda, Maryland 20852
Growing out of the DIA Annual Workshop on Statistical Methodologies in the Biopharmaceutical Sciences, the DIA/FDA Statistics Forum 2017 has been designed by a program committee, including members from the Office of Biostatistics (FDA/CDER), the DIA’s Statistics Community (Special Area Interest Community), and industry, to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. This meeting is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs and biologics. A primary focus of this meeting is to establish an on-going dialogue between industry and regulatory agencies -- emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and measuring the progress being made in designing and implementing innovative solutions.
Goals and Objectives:
- Explore and implement innovative statistical solutions to issues associated with the evidence and regulatory review of therapeutic drugs and biologics.
- Describe the application of statistical methodologies and thinking to the development of new therapeutic biologics and drugs.
- Assess the impact of regulations and guidance on statistical practice.
- Discuss ideas for improving the communication between Industry Statisticians and Reviewers.
Who should attend?
The workshop will be important for industry/government/academic statisticians, clinicians, epidemiologists, drug safety professionals, regulatory professionals and other stakeholders who are interested in the development and regulatory review of new and approved medical products.
To register to attend this event, visit the event registration page: DIA Global Forum website
Contact: Scott Goldie firstname.lastname@example.org