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Contenuto fornito da Subhi Saadeh. Tutti i contenuti dei podcast, inclusi episodi, grafica e descrizioni dei podcast, vengono caricati e forniti direttamente da Subhi Saadeh o dal partner della piattaforma podcast. Se ritieni che qualcuno stia utilizzando la tua opera protetta da copyright senza la tua autorizzazione, puoi seguire la procedura descritta qui https://it.player.fm/legal.
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139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh

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Manage episode 422056743 series 3325357
Contenuto fornito da Subhi Saadeh. Tutti i contenuti dei podcast, inclusi episodi, grafica e descrizioni dei podcast, vengono caricati e forniti direttamente da Subhi Saadeh o dal partner della piattaforma podcast. Se ritieni che qualcuno stia utilizzando la tua opera protetta da copyright senza la tua autorizzazione, puoi seguire la procedura descritta qui https://it.player.fm/legal.

This is a solo episode. On this episode, Subhi goes through:

01:51 Draft FDA Guidance - Platform Technology Designation Program for Drug Development Guidance for Industry

13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)

18:25 USP - <1157> USP-Listed Device Monographs and Recommendations for Product Quality and Performance Testing of the Drug Component of Combination Products

20:10 Race Recap: Sugar Badger 50K

26:51 Conclusion

Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. Subhi is an Ironman Triathlete and a Marathoner/Ultramarathoner.

  continue reading

148 episodi

Artwork
iconCondividi
 
Manage episode 422056743 series 3325357
Contenuto fornito da Subhi Saadeh. Tutti i contenuti dei podcast, inclusi episodi, grafica e descrizioni dei podcast, vengono caricati e forniti direttamente da Subhi Saadeh o dal partner della piattaforma podcast. Se ritieni che qualcuno stia utilizzando la tua opera protetta da copyright senza la tua autorizzazione, puoi seguire la procedura descritta qui https://it.player.fm/legal.

This is a solo episode. On this episode, Subhi goes through:

01:51 Draft FDA Guidance - Platform Technology Designation Program for Drug Development Guidance for Industry

13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)

18:25 USP - <1157> USP-Listed Device Monographs and Recommendations for Product Quality and Performance Testing of the Drug Component of Combination Products

20:10 Race Recap: Sugar Badger 50K

26:51 Conclusion

Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. Subhi is an Ironman Triathlete and a Marathoner/Ultramarathoner.

  continue reading

148 episodi

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