Workshop 2. Benefits and Strategies for Global Regulatory Data Streamlining, Harmonization, and Collaboration
Organizer: Laurie Goodwin, CropLife International, Belgium

Regulatory data streamlining and harmonization provides significant benefits for regulators, consumers, farmers, the environment, and developers.  Promoting consistent risk assessment data requirements accelerates innovation, assures consumer confidence, and provides clarity and predictability for developers which allows farmers timely access to beneficial technologies.  In this session, we will outline the benefits of regulatory harmonization and highlight the practical approaches being explored and implemented across jurisdictions for the safety assessment of GM crops be they for import and/or cultivation.  There are several key concepts that can facilitate regulatory data streamlining.  An important preliminary step to risk assessment is problem formulation. Problem formulation focuses the risk assessment on key questions, through considerations of the purpose of the assessment, as well as the scope and depth of the analysis and the analytical approaches required. The concept by which data generated in one geography can be transported to another with proper scientific justification is another concept that can facilitate data requirement streamlining. Utilization of transportable data across geographies/products has been successfully implemented in multiple countries to eliminate redundancy, create regulatory efficiencies and enable timely realization of the benefits of GM crops.  Finally, after almost 25 successful years of GM cultivation the concept of familiarity is becoming more and more relevant to discussions around safety-based risk assessments.  Our panel discussion will allow participants an opportunity to further discuss the key concepts introduced in this session.  Additionally, this session will provide an introduction to a workshop we anticipate being hosted Thursday afternoon after the Symposium where these concepts will be further explored in greater depth, and case studies currently employing these concepts will be introduced.
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