Nov 10 2011

Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies

Update: the slides are available here (pdf)

In today’s competitive climate, it is essential to optimize clinical trials during early development to best predict success in pivotal trials and position clinical outcomes for licensing and marketing.  Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval.  The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET.

Featured topics include:

  • Novel Phase 1 and 2 clinical study designs
  • Selection and optimal use of biomarkers, pharmacodynamic parameters, and PK analysis
  • Parallel FDA and EMA development pathways
  • Regulatory requirements and timelines in Europe
  • Conduct of foreign clinical studies under U.S. INDs

Our experts for the webinar are:

  • Professor Adam Cohen, CEO of CHDR
  • Dr. Kimberley Cummings, Senior Director, Regulatory Affairs at Cato Research.

Please visit the registration page to sign up for this webinar.

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