CPHI Webinar Series
Be prepared! Combination products under MDR (article 117)
What will this webinar address?
In this webinar you will be introduced to the drug combination "world" within the MDR Article 117, the role of the Notified Body, and fulfillment of the GSPRs and responsibilities and obligations of the manufacturer(s)
By attending, you will understand:
- What is a combination product
- The meaning of Article 117
- The role and task of the Notified Body
- Manufacturer responsibilities
- Evidence and fulfilment of the GSPRs
- Notified Body opinion
Heinrich Martens, VP Regulatory Affairs, with more than 15 years of experience working in Regulatory Affairs / Medical Devices. In his carrier, Heinrich Martens, was leading and being responsible for the various Regulatory Affairs projects – e.g. implementation of the Medical Device Regulation, leading and building up RA teams.
Leading an international team, across the globe, and being in contact with Authorities, Notified Bodies and Regulators – is one of his key topics, within his current role.
2014 - 2017: Apprenticeship as Industrial Business Management Assistant at Fresenius Kabi
2017 - 2020: Studies of international Business Management and Economics
since 2020: Junior Key Account Manager at Fresenius Kabi Contract Manufacturing Medical Devices
Responsible as main strategic contact person for business related topics in cooperation with our Fresenius Kabi Contract Manufacturing customers and partners
November 24th, 2021
4pm CET / 11am EST
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