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Wednesday, April 11 • 3:30pm - 5:00pm
Session CC - GLP FDA CDRH and J-GCP Track

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CC-1  CDRH Update (GLP-oriented)

CC-2 Revision of J-GCP based on ICH-GCP E6 (R2)

Abstract: TBA

Category: TBA

Level of Content: TBA

avatar for Fredda Shere-Valenti

Fredda Shere-Valenti

Have Passport Will Travel, Retiree and Volunteer
I'm presently happily retired and loving my volunteer work and traveling. Prior to retiring, I worked for FDA for almost 40 years, including 13 years at the Center for Veterinary Medicine in the Division of Compliance. My joy there was training the field consumer safety officers... Read More →

avatar for Annabelle Crusan

Annabelle Crusan

Annabelle Crusan, DVM, MS is a Veterinary Medical Officer at the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) at FDA. She reviews proposed and completed animal studies for evaluation of cardiovascular and orthopedic devices. She serves as liaison... Read More →

Antionette Johnson

Consumer Safety Officer, FDA
Antionette Johnson is a Consumer Safety Officer in the Office of Compliance, Division of Bioresearch Monitoring (BIMO), at FDA’s Center for Devices and Radiological Health (CDRH). She has been managing the Good Laboratory Practice (GLP) compliance program for nonclinical studies... Read More →
avatar for Toshiaki Tamura

Toshiaki Tamura

Astellas Pharma Inc
Toshiaki Tamura, PhDClinical QA Director, AstellasCQA for 17 yearsAstellas from 2005, Fujisawa from 1983PhD on Biochemistry

Wednesday April 11, 2018 3:30pm - 5:00pm PDT
Platinum 7&8