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Plenary Session 2: Round-Table: The Clinical Research System: Beyond Harmonization—A Role of Regulatory Agencies?

Day & Time:
October 21, 11:10AM - 12:50PM


Plenary Session 2: Round-Table: The Clinical Research System: Beyond Harmonization—A Role of Regulatory Agencies?

Greg Koski, MD
Alliance For Clinical Research Excellence and Safety (ACRES), United States

Honorio Silva, MD
Inter-American Foundation for Clinical Research (IAFCR), United States

There is growing evidence that the current health care system in the Americas and the clinical research that guides medical decisions are not aligned. The process of generating medical evidence through clinical trials is expensive and lengthy and is supported by a limited infrastructure. Numerous obstacles to producing such evidence have been identified, including the length of time and financial costs involved in conducting clinical trials, delays associated with the many regulatory and ethical requirements, difficulties in recruiting and retaining the appropriate patient population participating in clinical trials and the fragmentation among institutions supporting and/or sponsoring clinical trials. Further, there is often a lack of clarity among investigators regarding the roles and responsibilities of different oversight bodies. Multiple IRB approvals are required for large multicenter multi-country clinical trial and the inconsistencies n IRB determinations and standards across the world further complicate and delay the process of conducting clinical trials. Is there a role for regulatory agencies and experts to guide a study through its phases to ensure success. Initiatives to achieve further international regulatory harmonization aiming to ensure quality and minimize the risk of study participants are underway. In spite of significant leverage in clinical research regulation brought up by ICH, additional opportunities for improving the regulatory framework for clinical trials are needed. This session intends to explore such opportunities with leading experts from around the world. At the end this session, the attendees would be able to: 1. Describe initiatives developed by regulatory agencies in the USA, Europe and Latin America to advance clinical research across countries 2. Describe new regulatory guidance that may impact clinical research 3. Identify challenges and opportunities for a harmonized regulatory system and its alignment to country/regional health care systems

Presentation(s) & Speaker(s):
The Role of ANVISA in Fostering Clinical Research in Brazil
Alessandro Ferreira do Nascimento, MD
Clinical Research Coordination Expert
Brazilian Health Surveillance Agency (ANVISA), Brazil

Is Harmonization an Adequate or Achievable Goal?
Ingrid Klingmann
European Forum for Good Clinical Practice (EFGCP), Belgium

How can Regulatory Agencies Leverage Effectiveness of the Clinical Trials Enterprise?
Xavier Luria, MD
Senior Consultant
Drug Development and Regulation (DDR), Spain