Office of Research - The “ORB”

Better Translation of your IP into Rapid Development and Clinical Trials
When: 1 Feb 2012, 9am - 5pm
Where: BioSA Incubator Conference Centre, 40 - 46 West Thebarton Road, Thebarton SA
Cost: Free - including light lunch and refreshments

Ground Zero Pharmaceuticals, Inc. (GZP) focuses on bringing medical product programs through the FDA regulatory process, from late discovery through final approval and postmarketing.

This seminar will provide some suggestions for organisations, including:

  • The use of very early data to begin the regulatory dialogue;
  • An elegant and logical way to establish an integrated product development framework in the regulatory, preclinical/nonclinical, clinical, and manufacturing disciplines;
  • The use of a Target Product Profile to both guide and respond to emerging data; and
  • The importance of meeting early and often with the regulatory authorities to save precious time, resources and funding.

Further information (incl registration): http://bioinnovationsa.com.au/events/better-translation-of-your-ip-into-rapid-development-and-clinical-trials

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