Getting more clinical data has been talked about in Europe for a decade now, since the talks started on the ‘recast’, ultimately culminating in the MDR that is rapidly getting into full force. One of the core reasons behind the legislative update was to reinforce the rules on clinical evidence and strengthening of post market surveillance requirements for manufacturers. After having ignored the issue for a few years, many manufacturers moved to schedule large clinical trials, only to get to a realization that this could turn out to be unaffordable, and products would have to be removed from the EU market. In recent years the search has focused on the middle ground: finding cost effective ways and tools to create clinical data, and alternatively to just collect clinical data and turn them into clinical evidence. This workshop will guide you trough the benefit and pitfalls encountered in this middle road to clinical safety.
RAPS Euro Convergence is an annual programme created by European regulatory professionals for regulatory professionals operating in Europe and other countries who want to comply with European regulatory policies. The programme provides a specific forum for leading experts and professionals in the medical device, IVD, and pharmaceutical industries to examine and provide insight on the most urgent and crucial issues facing regulators, manufacturers, and regulatory professionals working with healthcare products for the European market.
RAPS is excited to announce that this year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes. And with this new online format, any sessions you can’t attend live, can be viewed on demand at your convenience.