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CLINUVEL Newsletter – April 2016

4 April 2016

Clinuvel is arriving at a point many of our patients and investors have longed for: first commercial treatment for EPP patients. Last month our European teams conducted a number of training and accreditation visits at European Hospitals. The purpose of these site visits was to instruct staff, management and clinical personnel on the regulatory requirements for following up with EPP patients in the longer term, as well as to train all involved on data collection, entry and management. Medical data protection is an essential topic where patients’ data are required for regulatory analyses. While data is entered by hospital staff, the onus of protecting patients’ data lies with Clinuvel, as the Marketing Authorisation Holder. Many professionals, independent bodies, and regulators are involved in the process while Clinuvel is expected to guarantee that patients’ privacy is protected and the data is secure.

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