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RAPS EUROCONVERGENCE 2021

Location

Virtual

Date & Time

7 May 2021 - 12 May 2021

 

 

 

RAPS Euro Convergence is an annual conference 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.

As last year, the 2021 conference will be held ‘virtually’ from Friday 7 May to Wednesday 12 May, with a wide selection of speakers from the drug, device and IVD sectors. At 10:00 on Tuesday 11 May, Donawa Lifescience’s President, Dr Maria E Donawa, M.D. will be the co-speaker with Danielle Giroud, President of MD-Clinicals, on the subject: ‘Risk Management: Compliance with Risk Management Requirements in ISO 14155:2020 During Different Clinical Development Stages of Clinical Investigations for Medical Devices, Including SaMD’.

Dr Donawa explains that ISO 14155 has been updated to include increased risk management requirements throughout all phases of clinical investigation planning and conduct. The first presentation in this session will provide an overview of the increased risk management requirements and what this means in practice. The second presentation will provide specific examples and methods for complying with the revised standard, including the new risk management requirements.

      RAPS Euro Convergence is an annual conference 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…

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