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

PDA Japan Prefilled Syringe Seminar

SPEECH

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.

10 - 11 September 2024

Sola City Conference Center

Tokyo - Japan

BOOK A MEETING WITH US

Speech

Daniel Martinez Photo
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
Event Location
PDA Japan Prefilled Syringe Seminar
10 - 11 September 2024

Sola City Conference Center Tokyo - Japan