Protocol Deviation - Violation - Exception - Webinar By Mentorhealth

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.

More than 80% of drugs for all indications entering clinical development do not get marketing approval, with many failing late in development often in Phase III trials, because of unexpected safety issues or difficulty determining efficacy, including confounded outcomes. A critical point is related to the clinical trial conduction within the sites. For the above mentioned reasons, it is important to know what deviations, violations and exceptions represent and when they could have an impact on the clinical trial results. On the other hand, it is important to underline in which situations a waiver could be given and a less strict Companys behavior could facilitate the study without compromising the study results.

Areas Covered in the Session:

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.

Who Will Benefit:

Production Managers

Monitors

CROs

Medical Oncologists

Professionals involved in the design of clinical trials in Oncology

Companies involved in the development of new anti-cancer drugs

Rossana Berardi, MD is a Consultant Medical Oncologist and Lecturer at University Hospital. She is also the Responsible of the Trial Unit at Dept of Oncology Universit Politecnicadelle Marche Italy. Dr Berardi usually deals with about 35 GCP trials/year with new drugs, with a special focus on early phase trials.

Dr Berardi is Assistant Professor in Medical Oncology and in Semiotics at Universit Politecnica Marche in Ancona and at the Doctorate in Osteoncology, Universit "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 Post-Lauream 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.

Dr. Berardi has been awarded many grants and prizes. She has authored many scientific publications and several presentations at national and international meetings. Dr.Berardi was a Research Fellow in the Department of Oncology at Middlesex Hospital, University College London Hospitals. Dr Berardi has a special interest in consulting with pharmaceutical companies regarding acquisitions and design of clinical trials. Dr Berardi has been selected as an expert evaluator in several boards of examiners (i.e. European Community).

by: Event Coordinator

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