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BRC Diabetes & Endocrinology

BioPharma Research Council

Tuesday, February 5, 2013 from 5:30 PM to 8:00 PM (EST)

Princeton Township, NJ

BRC Diabetes & Endocrinology

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Ticket Type Sales End Price Fee Quantity
Attendee Ended $40.00 $0.00
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BRC Individual Members or members of an Company/Organization that is a BRC Member.
Ended $20.00 $0.00

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Event Details

New EMA Guidance for the Development of Diabetes drugs have been published: Implication for inclusion of Continuous Glucose Monitoring (CGM) in clinical trials phase I-IV

 

“The use of devices allowing continuous blood glucose monitoring is encouraged and regarded as useful in adults and children to describe overnight glucose profiles and postprandial hyperglycaemia.”

 

The EMA published new guidance on June 29 covering the development of all diabetes drugs.  These guidelines went into effect in November making it very relevant and top of mind for all people involved in diabetes drug development.  These guidelines will have vast implications on all clinical trials for diabetes related drugs.  “The use of devices allowing continuous blood glucose monitoring is encouraged and regarded as useful in adults and children to describe overnight glucose profiles and postprandial hyperglycaemia.”  There are 5 separate mentions of Continuous Glucose Monitoring (CGM) within the guidelines covering orals, insulins and other injectable. 

 

Join us to hear clinical researchers and regulatory experts discuss the specific implications of the guidance, its possible interpretation, and data analytic techniques to get the most value from the data captured with this technology. Different product options and tradeoffs will also be addressed as well as practical tips and tricks for successfully integrating CGM into clinical trial protocols.

 

Moderator: Barbara Ameer, PharmD, MBA, BCPS, FCP, Robert Wood Johnson Medical School

 

Speakers:

Poul Strange, MD, PhD., Medical Director and President, Integrated Medical Development

 

Steve Stagliano, Program Manager, Institutional CGM, Medtronic Diabetes

 

Up-to-date, detailed information can be found at the BioPharma Research Council website at:

 

                     http://www.biopharmaresearchcouncil.org/forum.html

 

Have questions about BRC Diabetes & Endocrinology? Contact BioPharma Research Council

When & Where


Princeton Marriott at Forrestal
100 College Road East
Princeton Township, NJ 08540

Tuesday, February 5, 2013 from 5:30 PM to 8:00 PM (EST)


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Organizer

BioPharma Research Council

The BioPharma Research Council (BRC) is an independent, nonprofit corporation focused on the needs of the biopharmaceutical research community and its product and service suppliers.

We believe that scientific discourse and debate is central to the research and development process, and consistently provide a local forum for scientists to meet and share ideas on a broad variety of topics affecting the BioPharma Industry. 

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  News and Updates
2013-01-08 06:26:40


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