Pediatric Restless Legs Syndrome and Periodic Limb Movement Disorder in Children
Dr. Maha Ahmad, Attending Physician at the Sleep Disorders Institute presents "Pediatric Restless Legs Syndrome and Periodic Limb Movement Disorder in Children".
Participants will learn about the signs, symptoms, and treatment of Restless Legs Syndrome and Periodic Limb Movement Disorder in children.
Click HERE to view the recording of this webinar.
Essential Clinical Trial Designs Used when Developing Therapeutics
for Insomnia
Dr. Gary K. Zammit, President and CEO of Clinilabs, Inc. and Clinical Associate Professor at the Columbia University College of Physicians and Surgeons presents "Essential Clinical Trial Designs Used when Developing Therapeutics for Insomnia".
Participants will learn the fundamentals of clinical trial designs commonly used in the development of treatments for insomnia. Emphasis will be placed on early-phase pharmacokinetic, dose-ranging, and proof-of-concept study designs, as well as pivotal polysomnographic (PSG) and long-term outpatient studies. Participants will gain an understanding of the designs that are most appropriate for their needs, and which might have special applications for drugs with novel mechanisms of action.
Click HERE to view the recording of this webinar.
Assessing Cardiac Safety in Oncologic Drug Development
With the publication of ICH E14, cardiac safety studies have become standard components of drug development. Despite the widespread implementation of standards, drug development in oncology remains an ill-defined territory from the perspective of the regulatory expectation of defining cardiac safety.
Dr. Jonathan Sackner-Bernstein, formerly a consultant to the FDA’s Division of Cardiovascular and Renal Drugs and an expert on drug safety, presents “Assessing Cardiac Safety in Oncologic Drug Development.”
The objectives of this webinar were to clarify why the standards don’t apply to oncology and define rational strategies that will provide sponsors with adequate assessments of safety that should prove acceptable to regulatory authorities.
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