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  Events - April 2014

Clinical Evaluations and Investigations for Medical Devices

08 Apr 2014 - 09 Apr 2014 - Dublin, Ireland

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Preparing clinical evaluations and executing clinical investigations in the midst of the revision to MDD have given rise to an increasing challenge to satisfy the demands of Competent Authorities.

This year’s Informa Life Sciences’ Clinical Evaluations and Investigations for Medical Devices conference brings together Competent Authority, Notified Body and top industry experts to examine and interpret the regulatory expectations and to share best practice for preparing Clinical Evaluation Reports, clinical studies and strategies for successful market access and reimbursement.

  • Discover industry best practice for conducting clinical investigations in light of the revision to the Medical Device Directives
  • Hear MHRA feedback on the latest regulatory requirements for evaluations and investigations including: class III medical devices, implantables and combination products
  • Gain first hand feedback, advice and updates on clinical evaluation and investigation requirements from 5 Notified Bodies
  • Benefit from practical insights into carrying out a clinical evaluation
  • Enhanced networking and experience sharing opportunities with 3 new interactive sessions

Further information
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First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
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