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Seminar luncheon

Early Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential: A Pharmaceutical Industry Perspective


Speakers: Borje Darpo, MD, PhD, iCardiac Technologies
Organizers:
Date: 2017-02-03
Time: 11:00-13:30 Pacific Time
Registration fee (CDN): Food: $0.
Location: The Floral Hall at VanDusen Gardens, Oak St. at 37th Ave, Vancouver
Major Sponsor: (1)iCardiac Technologies
Vendor show vendors registered to date: (7)Altasciences; BRI Biopharmaceutical Research Inc.; Cardinal Health; Cellular Dynamics Intl; Eurofins Cerep-Panlabs; WORLDWIDE CLINICAL TRIALS; XenoTech
Registration: http://www.PBSS.org
Registration deadline:2017-02-01  (it will close sooner if the seating cap is reached)

About the Topic

Based on extensive experience with exposure response analysis of ECG data and the IQ-CSRC validation study, ICH 14 has been revised and now allows the thorough QT (TQT) study to be replaced by robust ECG monitoring and exposure-response (ER) analysis of data generated from First-in-Man studies. This seminar will discuss the IQ-CSRC study, requirements for Early QT assessment, share examples of successful TQT study waivers and give an update on recent regulatory discussions on studies using exposure analysis.

 

Who should attend:

Those working in academia and industry, pharmaceutical research and development, clinical development, regulatory affairs, and drug safety in general.


About the Speakers

Borje Darpo, MD, PhD, Chief Scientific Officer, iCardiac Technologies. Borje Darpo is board-certified in cardiology and internal medicine and Associate Professor of Cardiology at the Karolinska Institute since 2000. He has 11 years of pharma experience, including senior management positions in small, mid-sized and large pharma, as well as from a global CRO. He has led or has been responsible for projects in all phases of clinical development, including filing and approval of an NDA. Dr. Darpo’s experience from cardiovascular safety assessment of drugs is broad and includes participation in the generation of regulatory guidances on QT assessment and CV safety assessment.


2019-11-07, Preclinical Development & IND/CTA Filings: Nuts, Bolts and Best Practices: Day 2
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