Charles H. Pierce speaker of compliance global

19
Tuesday
July, 2016

Speaker: Charles H. Pierce
Duration: 90 Minutes
Product ID: 700463

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Protocol Deviations and Violations:The importance of knowing how to prevent them

With the increasing frequency of real-time FDA audits, the importance of the nature and frequency of evidence of “Not following the Protocol” has gained increasing importance. Protocol Deviations and Protocol Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study.

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Charles H. Pierce speaker of compliance global

03
Tuesday
March, 2015

Speaker: Charles H. Pierce
Duration: 90 Minutes
Product ID: 700002

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Criticality of Laboratory Data - including EKG - in the Drug Development Process

With the increasing frequency of real-time FDA audits and complexity of Investigational Medicinal Products (IMP’s), the wise are paying more attention to including a full range of lab tests to insure IMP safety.

Which lab values outside of the Reference range are to be reported as AE’s is always a question that must be answered and will be reviewed. The question of the relationship of lab data to “FDA Adverse Event reporting system” determination is the decision of the Investigator guided by what is in the protocol.

The section on “Safety monitoring systems” includes the array of lab tests taken at prescribed intervals adjudged to answer the safety questions. Whereas evaluation of this safety data is the Investigators responsibility, it is essential for the whole team and the sponsor to be on board with the timing and extent of this testing.

The source of lab data is also important, as for the data to be interpretable it must be accurate, reliable and repeatable. For this reason the choice of a lab following the principles of “GLP” (21 CFR 58) or, better, certified in “GCLP” is a goal to be obtained.

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Moving from an Operational Manager to a Strategic Leader

Speaker: Chris DeVany

Time: 01:00 PM EDT | 10:00 AM PDT
Location: New York

Logistics Channel Incoterms Standards

Speaker: Dr. Rossano V. Gerald

Time: 01:00 PM EDT | 10:00 AM PDT
Location: New York

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