DIA China Annual Meeting 2024
For the past 15 years, DIA China Annual Meeting has been the must-attend conference for all life science professionals working in lifecycle drug development, from discovery to marketed use in Asia. DIA China will continue to bring the key focuses on Regulatory Innovation, Science & Technology Innovation, and Talent Innovation to forward looking the trends of globalization and localization of drug development & innovation.
Visit Clario’s booth DS18 to talk with our experts and find out how we can help you succeed in your clinical trials.
Session information:
Title: Clario Innovation Theater: The ICH E14 Guidance and Oncology Trials
Dr. Vic Patel, Chief Medical Officer of Global Cardiology at Clario and Dr. Onglee Weng, VP & General Manager of Shanghai Clario will be discussing the development and requirements for discharging the risk of QTc prolongation with a new oncologic drug entity under the IHC E14 guidance at DIA China in the Innovation Theater on May 18, 2024 in Suzhuo. China’s National Medical Products Administration now requires all new drug entities to meet the ICH E14 requirement prior to market approval. In addition to meeting the standard ICH E14 requirements for discharging QTc prolongation, oncologic drugs pose unique challenges where FIH trials must be conducted in patients without positive or placebo controls. We will discuss how the E14 guidance allows for these special situations, as well as our experience in conducting hundreds of Through QT Studies globally and in China. Please join us for this special event if you are attending China DIA.
Time: 3:30 p.m. – 4:30 p.m.
Location: Exhibit Hall Innovation Theater 2
Date: May 18, 2024
Speakers
Onglee Weng
VP, General Manager at Clario Shanghai
Onglee Weng is the Vice President, General Manager, Clario-Shanghai. She has 20+ years of work experience in the drug R&D industry with 10+ years of overseas work experience. She was a licensed physician in Shanghai China before joining Clario (and its former companies) over 18 years ago. Dr. Weng led her team to successfully complete the first TQT trials in China and Japan. She also directed her team in completing ICH E14 and site trainings for several national leading phase I clinical centers in China, and jointly completed several research papers that have been published in international journals. Dr. Wend has participated in the formulation of ICH E14 & S7B Chinese translation and technical guidelines invited by China CDE. In her current role, she is responsible for managing both Clario’s medical imaging business and cardiovascular safety business in the Chinese market.
Vic Patel, M.D.
VP and Chief Medical Officer, Cardiology at Clario
Vic Patel, M.D., Ph.D., is board certified in cardiology with a PhD in Biophysics and done extensive research on mechanisms of cardiac arrhythmias. He was on faculty at U. Penn. School Medicine for 11 years where he directed Molecular Arrhythmia Research and practiced clinical electrophysiology. Dr. Patel then moved into drug development and cardiac safety as a clinical development leader and therapy area head across all phases.
At Clario, Dr. Patel oversees cardiology consulting and ECG/Holter core lab services, while leading the biostatistics and medical writing groups. He works with our global customers to ensure their needs are met with robust, cost-effective solutions.
Meet with us at DIA China Annual Meeting 2024.
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