Free on-demand Webinar: "Reduced cost and time-to-market with Ethno-Bridging Studies"

Insights from a clinical pharmacologist. Watch now.

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Join this webinar to learn about the design, conduct and analysis of ethnic bridging studies.
Find out about the relevance of such studies and understand the power of conducting them. Using Japanese/Caucasian bridging studies as an example we demonstrate all relevant points to consider.

Learn:

  • How to reduce cost and time to market using bridging studies
  • Best practice for the design of bridging studies
  • Pitfalls to consider in the planning of a bridging study
  • How and where to best run a Japanese bridging study

Webinar Synopsis

Since 2005, Profil has been able to successfully complete clinical bridging studies. Importantly, all of our studies have been completed within the agreed timeline. Our database contains 300 volunteers holding a Japanese passport with Japanese parents and grandparents and can easily be extended should the need arise.
Profil employs two research physicians with over 15 years of experience in ethno-bridging studies. In addition, we have a Japanese-speaking research physician and a native Japanese nursing staff that is involved in the performance of these trials.
Data from these types of clinical bridging study performed at Profil have already been used for NDAs in Japan. The acceptance of our data by Japanese authorities considerably accelerated the approval process. In fact, according to a publication from the Japanese regulatory agency, approval times could be decreased from 56 months to 32 months using an ethno-bridging strategy. This is a truly significant improvement. Thus it is accepted that when you run a bridging study Japan market entry can become faster and easier. 
 
In this Webinar, our expert for such bridging studies will share her experience and introduce the viewer to specific advantages and points to consider when planning to employ an ethno-bridging strategy.

 

 

Meet the presenter

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Dr. Grit Andersen has worked as a physician in several medical fields such as surgery, general medicine and neurology in Germany and Costa Rica. She started working in clinical research in 1999 in an international Phase III study, worked for 12 years in early phase studies and started working at Profil in 2013. She is a board certified medical specialist in clinical pharmacology and as Director Clinical Pharmacology she runs the specialisation program in clinical pharmacology for medical doctors at Profil Germany. At Profil she is also the senior expert  for our bridging studies. 

  

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