Drug-Device combination products - Article 117 of EU MDR with Theresa Jeary

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Article 117 from the EU MDR 2017/745 is amending the Medicinal Product Directive 2001/83/EC. So if you are developing a Drug that is using a Medical Device then you need to listen to this episode of the Medical Device made Easy Podcast.

Theresa Jeary will be my guest and she will help us understand what the Pharmaceutical Industry should do to place a product that contains a Medical Device on the EU market.

Don't forget to download the presentation prepared by Theresa.

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► Who is Theresa Jeary

Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has been involved in the development of many commercially available medicinal and medical device products.
Theresa has over 12 years of Notified Body experience, initially at BSI as a technical expert for devices with ancillary medicinal substance and she held the position of Head of Notified Body at the UK NB LRQA until January 2019.
Her core area of technical expertise is in the combination product area and Theresa now works as a consultant to the Pharmaceutical and Medical device sectors supporting Companies in meeting regulatory requirements. Theresa is a frequently invited speaker on the medical device legislation and combination products.

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► Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses...

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► Links from the Video

■ Theresa Jeary LinkedIn Profile:
■ Download Presentation:
■ FAQ EMA Article 117:

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► Social Media to follow

■ Monir El Azzouzi Linkedin:
■ Twitter:
■ Pinterest:
■ Instagram:

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