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DIA to Host 7th Annual Clinical Forum: Rebooting Clinical Development
Date:9/16/2013

and study data compliance measures? Lessons learned from experts in risk-based monitoring will be discussed with the audience. The session will be chaired by Estrella Garcia, head of global clinical operations and strategic resourcing for Almirall S.A., Spain.

  •     Post-Approval Studies and Virtual Studies, Oct. 8, 9 a.m.: As clinical trials need reliable access to patients or physicians to collect data, innovative virtual approaches have been developed to reach and involve patients directly. Experts will discuss how to organize registries and navigate the legal framework, and share their experiences in managing virtual trials and post-approval study design. Heike Schoen, managing director of LUMIS International, Germany, will chair the session.
  •     Patient-Centered Studies—Innovative Approaches to Include Patients, Oct. 8, 2 p.m.: As patients are now guiding research, the design of studies and the capturing and analysis of data, the session will address the impact of increased direct patient participation in and contributions to the clinical research process. The session will be chaired by Klaas Heinemann Jr., managing director of ZEG Berlin, Germany.
  •     Submission Challenges, Oct. 9, 2 p.m.: Marketing applications have become increasingly complex as the industry embarks on more extensive clinical development programs. The session will provide guidance on the key information to present in marketing applications and how to satisfy regional requirements. The session will be chaired by Nancy Tam, director of global medical writing, Biogen Idec, U.S.
  • ABOUT DIA: DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and life cycle management of pharmaceuticals, biotechnology, medical devices and related health care products. Through our international educati
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