Disclosure and Transparency for Clinical Data Summit


Transparency of clinical trial information is evolving on a global and national scale. Pharmaceutical companies and academia are overwhelmed by new regulatory requirements, operational challenges and renewed infrastructure needs to disseminate clinical trial data compliantly. These organizations are challenged to meet the ever-changing regulatory standards made by The Final Rule and EMA Policy 0070 of current, past and future clinical trials, but are struggling to establish compliant data transparency without universal regulations, standardized processes or regulatory support.

The Disclosure and Transparency for Clinical Data Summit convenes industry professionals to examine the global and national legislative landscape of data disclosure and transparency. The expert speaking faculty will determine the required internal infrastructure, resources and best practices to disclose transparent data that balances commercial and ethical responsibilities. Case studies will outline how to harmonize and standardize the execution of clinical trial data disclosure that meets federal and global criteria. This summit will provide attendees with the tools to be proactive in the changing regulatory environment to ultimately disclose transparent data that promotes brand integrity and ensures public understanding of the trial processes and results.

Exhibitors

René Allard, Public Disclosure Lead, GRÜNENTHAL GMBH; Bhanu Bahl, Ph.D., Director, Clinical and Translational Science Center, HARVARD MEDICAL SCHOOL; Kristen Bolt, Program Manager, Data Sharing and Transparency, MULTI-REGIONAL CLINICAL TRIALS CENTER OF BRIGHAM AND WOMEN’S HOSPITAL AND HARVARD; Karla Childers, Senior Director, Strategic Projects, JOHNSON & JOHNSON; Frantz Derilus, Associate Director, Clinical Trial Transparency, SHIRE; Julia Farides-Mitchell, M.A., Senior Project Manager, CENTER FOR INFORMATION & STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP); Sulochanda Gawande, Ph.D., Director, Oncology Medical Writing and Publications, EISAI; Greg Koski, M.D., Ph.D., President and CEO, ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES); Associate Professor, MASSACHUSETTS GENERAL HOSPITAL, HARVARD MEDICAL SCHOOL; Senior Scientist, MONGAN INSTITUTE FOR HEALTH POLICY; Debra Mayo, PharmD, MHA, Vice President, Global Scientific Communications, TEVA; Pranab Mitra, Ph.D., Principal Biostatistician, BRISTOL-MYERS SQUIBB; Oladayo Oyelola, Ph.D., Director, Clinical Trial Information Disclosure, DAIICHI SANKYO; Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB; Frank Rockhold, Ph.D., Professor of Biostatistics and Bioinformatics, Duke Clinical Research Institute, DUKE UNIVERSITY MEDICAL CENTER; Nathaniel Root, Global Clinical Trial Registration and Results Disclosure Lead, TAKEDA; Laura Troast, M.S., Associate Director, Clinical Data Disclosure and Transparency, MERCK;

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