DIA to Host 7th Annual Clinical Forum: Rebooting Clinical Development

Addressing the Changing Clinical Environment, Virtual Communities and the Role of the Patient

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DIA log

Dublin (PRWEB) September 16, 2013

DIA will host the 7th Annual Clinical Forum: Rebooting Clinical Development from Oct. 8 to 9 at The Convention Centre Dublin in Ireland with preconference workshops on Oct. 7 at the Clarion Hotel Dublin City. The conference will bring together international leaders in clinical development to explore how to effectively navigate the changing clinical development landscape. Several key topics for discussion include the impact of a risk-based monitoring approach, the implementation of virtual communities in trial structures and the emerging role of patients in the success of clinical studies.

“With this year’s theme, ‘Rebooting Clinical Development,’ the 7th Annual Clinical Forum will offer keen insight on how to develop, inform, maintain and monitor clinical trials,” said Jytte Lyngvig, director of DIA Europe. “Taking place in the heart of Dublin—a city with a long tradition as a European center of education and science and home to innovative biotechnology companies—this conference is an ideal venue for an exceptional exchange of expert knowledge.”

Lyngvig and Detlef Nehrdich, a senior associate with Waife & Associates, will deliver the welcome address, followed by the plenary debate, “This House Believes That in Ten Years There Will Be No Clinical Trial Operations Staff in Europe.” The discussion will focus on the ability to perform valuable clinical research in Europe amid an unstable economic climate and explore the notion of shifting research to emerging economies.

Key 7th Annual Clinical Forum sessions include:

  •     Risk-Based Monitoring – Part I, Oct. 8, 9 a.m.: Risk-based monitoring offers opportunities for quality improvements, but are we prepared to implement the new paradigm 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 educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well-being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; Beijing, China; Washington, D.C.; and Latin America. Visit our website at http://www.diahome.org and follow DIA at: LinkedIn, Twitter, YouTube, Facebook, Flickr and Pinterest.