Human Abuse Liability Role in NDAs

Clinical Trials, Life Sciences, Pharmaceutical Regulation ,
  • April 15, 2014

Abuse and addiction are serious global health problems. All drugs with rewarding properties have the potential to be abused. Therefore the FDA requires most CNS acting drugs to be assessed for their abuse potential. The most common clinical method for drugs to be evaluated for their abuse potential is with a Human Abuse Liability (HAL) study.

The presentation will discuss when a HAL study will likely be required and how a HAL study is conducted.

Keywords:

Speakers

Dr. Lynn Webster, Vice President of Scientific Affairs, PRA, and President, American Academy of Pain Medicine

Dr. Lynn Webster is co-founder and Chief Medical Director of Lifetree Clinical Research® (now CRI Lifetree Salt Lake City Center). His research interests are diverse. He is keenly interested in working with industry to develop safer and more effective therapies for chronic pain and addiction. He is a leading researcher in exploring the relationship of medications and sleep, with particular interest in analgesic-induced sleep-disordered breathing.

Dr. Webster is board certified in anesthesiology and pain medicine and is also certified in addiction medicine. He earned his doctorate of medicine from the University of Nebraska Medical Center and completed his residency in the University of Utah Medical Center’s department of anesthesiology.

Who Should Attend?

  • VP/Director/ Head of Research & Development
  • VP/Director/ Head of Regulatory Affairs
  • VP/Director/ Head/Director/Manager of Operations
  • VP/Head/Director/Manager of Clinical Development
  • Chief Scientific Officer
  • Chief Medical Officer
  • Clinical Development Project Management

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PRA

As the world’s fourth largest CRO, PRA is transforming clinical trials through our people, innovation and transparency. We combine therapeutic and operational expertise with local knowledge to serve clients across all phases of drug development. Our successful history of helping to bring new drugs to market demonstrates our successful approach to clinical research.

We operate in 80+ countries with more than 10,000 employees, seamlessly delivering comprehensive Embedded and clinical trial services with our advanced technological tools and finely tuned systems. Our dynamic services, operational transparency and forward-thinking approach are making a difference to healthcare patients worldwide.

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