How to register ATMP-Device combination products?
ATMP stands for Advanced Therapy Medicinal Products, which is a category of Medicinal Product. But if I combine this with a Medical Device, how should this be regulated and how can I register this product in Europe?
Effectively, this is exactly the question that Margareth Jorvid from Methra Uppsala AB will help us to answer. So if your product is combined with a Medical Device, you should listen to that.
Remember, we had a previous episode specifically on combined products Drug-Device but here you’ll see that the process is a bit different.
To help you understand, we will review the requirements of the 1394/2007 regulation. It contained already requirements on how to manage ATMP-device combined products.
Who is Margareth Jorvid?
Margareth Jorvid has over 30 years of experience in Regulatory Affairs and has worked at the Swedish Medical Products Agency (MPA) as well as large and small pharmaceutical and biotech companies, such as Roussel Nordiska, Hoechst Marion Roussel (in Stockholm and Paris, France) and Neopharma.
Since 2006, consultant in regulatory affairs and QA for pharmaceuticals, ATMP (cell- and gene therapies), medical devices, and combination products through her company Methra Uppsala AB, LSM group.
Additionally, she is a member and honorary member of TOPRA (Organisation for Professionals in Regulatory Affairs), previous board member, and TOPRA president from 2005-2006.
She holds a MSc Pharm from Uppsala University, a MBA from Stockholm School of Economics, Sweden, and a MSc MTRA from Cranfield University, UK.
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.
Recently, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links
- Margareth Jorvid Linkedin Profile: https://www.linkedin.com/in/margareth-jorvid-60059440/
- EMA, Advanced Therapy Medicinal Products: https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview
- EMA, Legal framework for ATMPs: https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview
- Regulation (EC) No 1394/2007 (ATMP regulation including combined ATMP): https://bit.ly/3kSzMgQ
- ATMP Classification: https://bit.ly/3kSwnyE
- Summaries of scientific recommendations on the classification of advanced therapy medicinal products, including examples of combined ATMPs: https://bit.ly/309NHHa
- Marketing-authorization procedures for advanced-therapy medicinal products: https://bit.ly/3j8fT4S
- Procedural advice on the evaluation of combined advanced therapy medicinal products and the consultation of Notified Bodies in accordance with Article 9 of Regulation (EC) No. 1394/2007: https://bit.ly/3cynerO
- Interview Ilya Pharma: https://www.ilyapharma.se/news-list/meet-margareth-jorvid-leading-innovations-to-products/
- Company Immunicum: https://immunicum.se/
- TOPRA Symposium 2020: https://www.topra.org/sym2019
- Podcast episode on Drug-Device combination products: https://podcast.easymedicaldevice.com/71/
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