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Live Webinar
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Protocol Deviation - Violation - Exception
Date & Time: Tuesday, January 22, 2013
10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: Rossana Berardi
Location: Online
Price : $195.00
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Instructor Profile: Rossana Berardi Consultant Medical Oncologist and Lecturer , University Hospital
Overview: The introduction of new drugs and the ongoing researches on therapies directed at critical molecular targets require a good knowledge about the conduction of clinical trials. This webinar will help you understand the
Rossana Berardi is a Consultant Medical Oncologist and Lecturer at University Hospital. She is also the Responsible of the Trial Unit at Dept of Oncology – Università Politecnicadelle Marche – Italy. Dr Berardi usually deals with about 35 GCP trials/year with new drugs, with a special focus on early phase trials.
significant differences between the terms deviation, violation and exception and the possible implication in the final results of a clinical trial.
Why should you attend: The introduction of new drugs and the ongoing researches on therapies directed at critical molecular targets have caused several difficulties among Medical Oncologists and as well as among Companies and CRO.
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We will begin by reviewing the traditional statistical design of clinical trials in Oncology We will look over the introduction of targeted therapies in the Oncology field and the related different needs We will also review the requirements of the regulatory authorities (FDA, EMEA) and we will focus on the meaning of the terms deviation, violation and exception and their impact on the clinical trials conduction and results.
Dr Berardi is Assistant Professor in Medical Oncology and in Semiotics at Università Politecnica Marche in Ancona and at the Doctorate in Osteoncology, Università "Campus Bio-Medico" in Rome. She is Member and national representative of the Lecturers in Medical Oncology of the Academic Medical Oncology Committee, Member of the “PostLauream Education” Working Group of the Italian Association of Medical Oncology and Member of the “Core Curriculum” task force of the European Society of Medical Oncology. ....more
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