Webinar: Safety and Assessmen of ECG and ABPM in Clinical Trials featuring Dr. Michael Klepper
Tuesday, April 23 2013
Biomedical Systems Webinar
If you cannot view this email click here to learn about an upcoming webinar from Biomedical Systems.
Dr. Michael Klepper, global expert and consultant in the field of pharmacovigilance and drug
safety for over 25 years, will review how raw ECG and Ambulatory Blood Pressure data is collected
at the study site and converted into a meaningful "story" of the risk profile of an investigational
drug. This complimentary webinar will also discuss the different types of analysis and the
determinants of a clinically significant drug effect.
- Identify the benefits of collecting ECG and ABPM data in clinical trials
- Define and explain standard ECG and ABPM parameters
- Interpret clinical significance by identifying and categorizing safety findings
- Determine risk minimization strategies
Michael J. Klepper, MD
President and Founder
Drug Safety Navigator
As a global expert and consultant in the field of pharmacovigilance and drug safety for more than
25 years, Dr. Michael Klepper works with biotech and pharmaceutical companies to develop and
implement "Best Pharmacovigilance Practices" and to assist clients in the "benefit to risk" analysis
of their products, in both clinical and post-marketed settings. Because of today's complex drug
safety problems, Dr. Klepper capitalizes on his vast experience to uncover hidden landmines and
potentially costly delays, and to determine pragmatic solutions for his clients. He comfortably works
with small to large companies as lead safety consultant and advisor.
Dr. Klepper is former President and CEO of Integrated Safety Systems®, Inc. (ISS) and former Vice
President of Research Triangle Institute – Health Solutions (RTI-HS). He recently coauthored Drug
Safety Data – How to Analyze, Summarize, and Interpret to Determine Risk and in his book, Dr.
Klepper reveals his passion for drug safety and for training the next generation of drug safety
experts. He often notes that there is little time in today's world for on-the-job training, so it is
critically important to transmit and convey the data, knowledge, and experience of current
pharmacovigilance practitioners through all available means.
Dr. Klepper is a frequent speaker and trainer at many industry seminars and forums, including
China where he conducted a seminar on "Adverse Event Reporting and Pharmacovigilance".
Dr. Klepper received board certification in Internal Medicine and Emergency Medicine and is Past
President of the Research Triangle Park Chapter of the American Academy of Pharmaceutical
Physicians. Dr. Klepper's interests are in all aspects of biopharmaceutical and device product safety.
This interest extends to the application and evaluation of new technological tools as they relate to
risk assessment and early safety signal detection.
Dr. Klepper Specializes in:
- High level strategic consulting in drug safety/pharmacovigilance
- Establishing "Best Pharmacovigilance Practices"
- Benefit-risk assessments of medical products during development and post-marketing
- Drug safety training
- Summary of Clinical Safety (SCS)/Integrated Summary of Safety (ISS)
- Risk management and risk minimization strategies
- Medical review
- Periodic Safety Update Reports (PSURs) & new Periodic Benefit-Risk Evaluation
- Developmental Safety Update Reports (DSURs)