Revision of the NCAR Exchange Program Dr. I sabelle Dem ade NW I - - PowerPoint PPT Presentation

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Revision of the NCAR Exchange Program Dr. I sabelle Dem ade NW I - - PowerPoint PPT Presentation

Jan 05, 2024 131 likes •249 views

Revision of the NCAR Exchange Program Dr. I sabelle Dem ade NW I Chair IMDRF Sydney 23-26/ 09/ 2012 Background - Current scope : - exchange of (confidential) info on serious Adverse Event (AE) concerning MD with global distribution

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SLIDE 1

Revision of the NCAR Exchange Program

  • Dr. I sabelle Dem ade

NW I Chair IMDRF Sydney 23-26/ 09/ 2012

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SLIDE 2

Background

Current scope:

  • exchange of (confidential) info on serious

Adverse Event (AE) concerning MD with global distribution

Participants

  • GHTF Reg. Authorities
  • Reg. Authorities fulfilling the criteria of N38 &

successfully trained on N54 & N79

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SLIDE 3

Background

State of Play □ Total: 29 participants (out of which 9 are non GHTF members)

  • interest of AHWP members & more recently

South America □ number of NCARs exchanged:

  • approx. 250 per year.
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Underlying requirem ents

  • ne focal point for supervision & distribution:

NCAR Exchange Program Secretariat (currently TGA)

Expanding membership

  • training (and re-training)

requires training materials, trainers,.. = N 120: training on PMS

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Critical Review -Step 1

  • 2 regulators-only sessions prior to SG2 meetings

Ł NCAR Exchange provides useful inform ation.

  • Ł

Downside: uneven participation

  • limited contribution from key GHTF

jurisdictions

  • poor participation from new members ram.
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SLIDE 6

Critical Review -Step 1

  • Ł

The benefits:

  • early access to relevant safety-related

information; knowledge about action taken (FSCA, recall,..)

  • Ł

The frustration:

  • why are so few ( GHTF) jurisdictions using the

NCAR Exchange Program?

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SLIDE 7

Critical Review -Step 1

  • Ł

Trend : besides AE & FSCA/ recalls reporting □ sharing information on action taken by Manufacturer (Field Safety Notice), □ on newly identified issues (and request for feedback)

  • □ requesting information on post-market issue.
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SLIDE 8

Critical Review -Step 2

  • conducting a survey on participants'views:
  • on contribution level,
  • recommendations for improvement
  • training needs,
  • scope
  • Oct. 2 0 1 2
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SLIDE 9

Critical Review

  • Step 2 (cont.)

Reviewing survey data & setting priorities

Through 2 0 1 2 -early 2 0 1 3

  • Step 3

Developing proposals

Through 2 0 1 3

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Critical Review

  • W G com position
  • Experience:

SG2 regulators & fresh view

  • Geographic representation:

GHTF jurisdictions, IMDRF new member(s), + inviting AHWP representative;

  • Must have: operational responsibilities in post

market safety.

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SLIDE 11

Thank you for your attention!

K