Medifacts International:
Who: | Â | Medifacts International, Jeff Heilbraun and Boaz Mendzelevski, MD |
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Title: | Recognizing the Cardiac Safety Continuum; Meeting the Evolving Cardiac Safety Requirements for New Medicinal Entities from Diabetes to Oncology | |
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Date: | Monday, September 21st, 4pm-7pm | |
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Where: | North Carolina Biotechnology Center, 15 T.W. Alexander Drive, Research Triangle Park, NC | |
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Cost: | FREE | |
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Website: | http://www.medifacts.com/index.php/ | |
Topics:
- Cardiovascular Safety Concepts for Oncology Agents—From QT Prolongation to Tissue Toxicity
- New Regulatory Requirements for Cardiovascular Safety Assessment of Type 2 Diabetes Mellitus Drugs in Development
- The Thorough QT Study—Design & Compliance with E14 & FDA Requirements
- Blood Pressure as a Cardiac Safety Endpoint: Practical Considerations for Blood Pressure Endpoints In Clinical Trials
About the Speakers:
Jeff Heilbraun, Executive Director, Corporate Strategic Development
Jeff joined the Medifacts team in 1993 and has supported activities in Data Management, Operations, and Business Development. Throughout his career at Medifacts, Jeff has maintained his focus on the science and physiology behind cardiac safety within pharmaceutical development, with a special interest in hemodynamics. Jeff has presented posters at the Drug Information Association (DIA) meeting, American Society of Hypertension (ASH), Canadian Clinical Pharmacology Association and recently at the Cardiac Safety Research Consortium (CSRC) where he is presently leading the development of a white paper on the blood pressure safety considerations for non-hypertension compounds. Mr. Heilbraun attended Tufts University in Boston, Massachusetts were he completed his Bachelor of Science degree in Biology with a focus on physiology. Jeff continued his studies at The American University in Washington D.C. where he received a fellowship and completed his Masters of Science in Health Promotion and Disease Management.
Boaz Mendzelevski, MD
Vice President of Cardiology & Chief Medical Officer
Dr. Mendzelevski received his degree in Medicine and Board Certification in Internal Medicine from the Ben-Gurion University Medical School and Hospital in Beer-Sheva, Israel. He then trained in cardiology and received a board certification in Cardiology from the Shaare-Zedek Medical Centre and Hebrew University in Jerusalem, Israel. Dr. Mendzelevski completed further postgraduate training in Interventional Cardiology and Clinical Electrophysiology at the Royal Brompton National Heart and Lung Hospital in London.
Dr. Mendzelevski has authored approximately 220 cardiology expert reports, most of which supported NDA regulatory submissions. He has represented pharma clients before the US FDA and the European regulatory authorities on several occasions and has participated in multiple pharmaceutical advisory boards and Data Safety Monitoring Boards (DSMBs). Dr. Mendzelevski was the only CRO expert to be invited by the FDA and ICH to serve on the ICH-E14 expert advisory panel.
About MEDIFACTS
Driven by best-in-class Science, Technology, and Service Quality, Medifacts International has become a global leader providing ECG, Holter, Ambulatory Blood Pressure Monitoring, Spirometry, Glucometry, Pulse Wave Analysis and related services to pharmaceutical, biotech and medical device companies.
Medifacts International’s scientific expertise, proprietary WebHeart® technology, global presence and recognized quality leadership has established Medifacts International as one of the top 3 providers in comprehensive cardiac safety and efficacy services.
WebHeart® is a proprietary, global, web-based platform that offers a complete solution to acquiring, displaying, measuring, and managing cardiac safety and efficacy data in clinical trials. This system allows for live, genuine real-time access to ongoing study activity and data, delivering value added services to Medifacts International’s clients alongside operational and cost efficiencies. Because no actual programming is needed, the time and cost of both study setup and data submission are dramatically reduced.
Contacts:
for Medifacts
Agency Moritz
Preston T. Moritz,
215-605-0993
preston@agencymoritz.com
www.agencymoritz.com
