How Are Clinical Trials Impacted By The GDPR? | Webinar
Often described as the most important development in data privacy regulation, the General Data Protection Regulation (GDPR) is intended to strengthen data security for individuals. With violations set to generate fines for organisations of up to €20 million or 4% of annual turnover, the GDPR is not something that medical device companies can afford to ignore.
Join Aly Talen and Nico Busch for a 30-min. webinar to better understand how the GDPR will impact clinical trials.
Discussion points will include:
- Main aspects
- Clinical trial data
- Sponsor compliance
- Data transfer
- Data Protection Officer
- Data Representative
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Aly Talen is a thoroughbred clinical researcher with a distinct focus on medical devices. She started her research career as a Clinical Advisor at the Spectranetics Corporation (now Royal Philips, NYSE: PHG) in 1997. She founded the CRO ‘Talen Clinical Trial Management’ in 2001 which led to genae in 2005. The latter transformed to a recognized global services provider for the medical industries, with offices in the US, Europe, Middle East and Asia Pacific.
Nico Busch, lawyer by education, functions as Regulatory Affairs Manager at genae and is responsible for positive votes of ECs and approvals of CAs - internationally. Besides that, he takes care of legal issues of the company. The combination of his law background and his experience of medical device clinical trials makes him the most suitable person to discuss GDPR in device trials.