The backbone of most regulatory submissions are clinical pharmacology summaries based on noncompartmental analysis (NCA) results (with support from population PK/PD analyses) - yet these steps are often overlooked as many analysts tend to jump into more complex analysis immediately.
Using real-life data from African studies, this webinar will introduce you to the importance of exploratory data analysis and NCA. The theoretical and practical aspects will be presented as well as what analyses, tables and figures can be used to communicate the results. All scripts and codes will be provided.
When: 4 November 2019, 3:00PM GMT
Where: Live webinar (internet access required)
Faculty: Dr. Samer Mouksassi, Sr. Director Integrated Drug Development, Certara Strategic Consulting
To Register: Click here
Faculty:
Dr. Samer Mouksassi is a Senior Director Integrated Drug Development at Certara Strategic Consulting. Since 2007, he has been responsible for implementing model-based drug development, PK/PD modeling and simulation, advanced statistics, realistic clinical trial simulations to help sponsors with regulatory submissions and decisions where his team got numerous approvals from FDA, MEA and Japan. Since 2014, he has been dedicated to the Knowledge Integration Quantitative Sciences team at the Bill and Melinda Gates Foundation to support various programs for the Maternal, Neonatal, and Child Health Initiative. Samer has a passion for teaching and is currently Associate Professor of Pharmacometrics and Clinical Trial Design at Université de Montréal and Lebanese American University. Samer received his Pharm.D from Lebanese University, and Ph.D. in PK/PD modeling from Université de Montréal. He has co-authored over 100 scientific communications (manuscripts, posters, invited presentations) and supervised several MSc and PhD students. His open source R packages focus on insightful exploratory data analysis.
For any questions, please contact Adeniyi Olagunju.