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Webinar Resources

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In partnership with the Safety Pharmacology Society (SPS), ASCPT encourages members to attend an upcoming SPS Webinar: 
Title: Drug-Induced QTc Prolongation and Torsades de Pointes (TdP): Evolving ICH S7B and E14 in Light of Emerging Data
Date & Time: 11:00 AM ET, Thursday, May 16, 2019 
Speakers: Jean-Pierre Valentin, PhD, UCB Biopharma SPRL, and Derek Leishman, PhD, Eli-Lilly
Moderator: Simon Authier, MSc, PhD 
Description: The ICH S7B and E14 described the non-clinical and clinical risk assessment strategies respectively, to inform the potential risk for proarrhythmia of a drug and contribute to the design of clinical investigations. Since the implementation of these guidelines in 2015 there has been no drug withdrawn for an unacceptable risk of TdP and most drugs evaluated clinically nowadays are negatives owning largely to a “hERG centric” discovery screening strategies. Over the past several years, emergent data (e.g., CiPA, JiCSA) has increased our mechanistic understanding of drug-induced QTc prolongation and TdP. Consequently, guidance is needed regarding best practices for the design, conduct, analysis, interpretation, presentation and reporting of in silico, in vitro and in vivo non-clinical assays in order for these assays to influence non-clinical and clinical evaluation. Register for this presentation to learn more about when and how novel approaches could play a role in determining the proarrhythmic risk to inform clinical development.
Registration: http://bit.ly/2PyfNW4

ASCPT Members-Only Webinar presented by the Early Development & Drug Safety Community
Title: First-in-Human Starting Dose Selection: Learnings from Survey by IQ MABEL Working Group and Experiences of the Regulatory Agency
Date and Time: Wednesday, May 22, 2019, 12:00 pm ET
Speaker: Haw-Jyh (Brian) Chiu, PhD
Moderator: Chao Han, MSc, PhD
Description: The importance of selecting a proper first-in-human (FIH) starting dose has been increasingly comprehended by the pharmaceutical industry and regulatory agency since the TeGenero incidence in 2006. The minimum anticipated biological effect level (MABEL) approach was proposed by the EMEA in 2007. Ten years later, an IQ Working Group conducted a cross-industry survey about the practice and performance of using MABEL. The results will be shared during this special presentation along with the observations and recommendations made by the working group. The Office of Hematology and Oncology Product at the US FDA has retrospectively analyzed preclinical data and approaches used for FIH starting dose selection. The experiences will be presented with some insightful discussions for assessing and establishing more efficient approaches for FIH dose selection.
Registration Link: https://attendee.gotowebinar.com/register/3154649891752265987

ASCPT Members-Only Webinar presented by the Early Development & Drug Safety Community
Title: Patient Reported Outcomes (PRO) Symptom Data to Complement Traditional Exposure-Response (ER) Analysis for Dose optimization During Breast Cancer Drug Development
Date and Time: Thursday, May 30, 2019, 1:00 pm ET
Speaker: Jeanne Fourie Zirkelbach, PhD
Moderator: Huiming Xia, PhD
Description: There is increasing interest in enhancing assessment of symptomatic adverse events (AEs) using patient self-reporting. In this presentation, exploratory efforts and results and future directions in term of how patient-reported outcome (PRO) - based Exposure Response analyses can complement conventional exposure-response (E-R) analysis will be discussed.
Learning Objective: Learn How Patient Report Outcome Endpoint Can Inform the Dose Selection and Dose Optimization.
Registration Link: https://attendee.gotowebinar.com/register/3232717416347253507

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