This webinar is part of a series of 2 webinars. Second webinar: November 22, 2022 from 13h00 to 14h00: The sources of life scineces regulations - part II: medicinal products.
This is the second of two webinars. You can already register for both and get a reduction as a non-member (both webinars are free for Healixia members). Registration for this single webinar on September 9, will soon be possible.
This online workshop will discuss the IB structure, content and quality as important topics for all parties involved in planning, set-up, conduct and interpretation of a clinical study. Some practical highlights will be shared on challenges on writing a “good” IB for a FIH/Early Phase trial on the one hand, and on how to use it for an optimal benefit-risk assessment on the other hand. The latter being essential to safeguard the participants in clinical trials.
During this session, we will tackle the required departmental (inter)actions for ensuring full GxP compliance. The Marketing Authorization Holder’s responsibilities will be highlighted within the legal framework of the different good practice guidelines (GMP, GDP, GVP…).
The global pandemic is affecting clinical trials to an extent never previously encountered. Due to preventive measures against the COVID-19, patients cannot travel to sites and sites cannot perform all assessments. Professionals of clinical trials have made huge efforts to operate remotely, with methods like delivering investigational drugs directly to patients, telemedicine or remote monitoring and more as site access has remained restricted. The goal of this research project was to understand how the pandemic is impacting clinical research personnel's work and to analyze how they adapted to this unprecedent situation. In this webinar, the results of conducted research on the impact of Covid-19 on clinical trial execution by Prof. Yves Geysels (Dept of Biomedical Sciences, University of Namur) will be discussed.