This workshop is designed for people who are involved in clinical research, whether they are involved in drug development activities in the pharmaceutical industry or they work in the academic setting.
The workshop provides an overview of the main basic principles that a clinical researcher must know from a regulatory, medical, and statistical perspectives. Firsts, the different types of clinical studies are discussed in a way that shows the kind of scientific questions that each type is meant to answer. Then, the workshop focuses on the key elements of a clinical study design, such as the scientific question, the endpoints, the comparator, and others. The workshop leader shares his extensive experience in this field and proposes simple tools to navigate in a complex environment. Finally, some real examples of endpoints will be proposed to the participants to practice their learning. Participants are also encouraged to bring their own cases for discussion.
AGENDA
14:00 – 14:15 Introduction
14:15 – 14:30 General Principles
14:30 – 15:00 Types of Clinical Studies
15:00 – 15:15 Break
15:15 – 16:00 Key Elements of a Clinical Study
16:00 – 16:15 Break
16:15 – 17:00 Formulating objectives and endpoints/practical examples (Participants are encouraged to bring their own cases for discussion)
ALI EL-ALI
Before starting his freelance activities, Ali held multiple positions as medical practitioner, as well as multiple executive positions in the pharmaceutical industry. The most recent position he held was the Senior Franchise Head, Hematology, in the oncology unit, at Novartis Pharma. During his time in the pharmaceutical industry, Ali worked on a large number of clinical studies, which allowed him to combine a rich practical experience in clinical research with an academic education in this field.
Ali earned his MD degree from the Russian State Medical University (RSMU), Moscow; and completed his training in gynecologic oncology at the RSMU and the University Claude Bernard, Lyon I. He completed a post-graduate program in Clinical Research Methodology at McGill University, Montreal, as well as an MBA program at the School of Hautes Etudes Commerciales (HEC), Montreal, Canada.
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Registration: https://www.eventbrite.com/e/initiation-to-clinical-research-methodology-by-ali-el-ali-registration-84573831607