PDA Japan Prefilled Syringe Seminar 2024 - Stevanato Group
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2024-09-10 00:00:00
2024-09-11 00:00:00
Sola City Conference Center
Tokyo - Japan
35.6986943, 139.7663189
n.a.
PDA Japan Prefilled Syringe Seminar
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Events
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PDA Japan Prefilled Syringe Seminar 2024
PDA Japan Prefilled Syringe Seminar
スピーチ
PDA Japan Prefilled Syringe Seminar
10 - 11 September 2024
Sola City Conference Center
Tokyo - Japan
Join us at the next PDA Japan Prefilled Syringe Seminar - “Combination Products for tomorrow".
Visit the expo area and meet us at Stevanato Group tabletop 8.
BOOK A MEETING WITH US
Daniel Martinez Photo
Wednesday, September 11th - 9:00 am to 9:40 pm (JST)
Session E - «Regulatory Trends for Combination Products»
Daniel Martinez - Product Manager
«TR 73-2 Application of EU Medical Device Regulation to Prefilled Syringes.»
Abstract
- An addendum to PDA Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology Applications
- Facilitate obtaining a Notified Body Opinion (NBOp)
- Process based on a new EU regulatory medical device requirements (MDR)
- Applies to prefilled syringes of glass and polymer
- Evidence of Conformity of the Device Part of the Prefilled Syringe
- Supportive Documents Suggested to Address Relevant GSPRs
Event Location
PDA Japan Prefilled Syringe Seminar
10 - 11 September 2024
Sola City Conference Center
Tokyo - Japan