Programme

2017, May

When developing E-healthcare technologies with the objective to market them in Europe, it is key to well understand the regulatory issues to launch a product on time on the market.
The objective of this webinar is to present how to implement a strategic development plan for e-healthcare solutions while taking regulatory requirements into account in order to minimise risk.

During this webinar, the following issues will be discussed:

  • Applicable regulatory environment
  • E-healthcare products' Development and assessment
  • Main regulatory obstacles in Europe

Experts

Christophe AMIEL Senior Director, Medical Devices & Combination Products @ Voisin Consulting Life Science

Having 20 years' medtech experience and conducting global regulatory strategic analyses from early development phases to market access, Christophe focuses on the anticipation of regulatory and practical challenges associated with innovative systems such as e-health technologies. He leads the preparation of regulatory strategy, the submission of regulatory applications in Europe and the US, the interaction with regulatory bodies (Notified Bodies and national health Competent Authorities), the preparation of risk management plan and the support of Pre- and Post-market medical device vigilance activities and reporting.

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