ASSOCIATION OF MEDICAL DIAGNOSTICS MANUFACTURERS
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2019 AMDM Annual IVD Regulatory Meeting Evaluation
Please use the scale below to rate the following speakers in terms of content and delivery:
1=Unsatisfactory 2=Fair 3=Satisfactory 4=Good 5=Excellent
April 10 / Session 1
IVD Industry Overview / Kahan
*
5
4
3
2
1
Real World Evidence... / Bush
*
5
4
3
2
1
4-10-1 Comments
*
April 10 / Session 2
Roundtable with OIR Management Team
*
5
4
3
2
1
Breakthrough Designation / Vietz
*
5
4
3
2
1
Diabetes Update / Silk
*
5
4
3
2
1
CLIA Waiver / Kondratovich
*
5
4
3
2
1
Successful Submissions for POC / Perez-Torres
*
5
4
3
2
1
CLIA Waiver / POC Diagnostics / Boiani
*
5
4
3
2
1
IVD Vigilance / Cowan
*
5
4
3
2
1
4-10-2 Comments
*
April 11 Session 1
Facing IVDR Challenges Panel
*
5
4
3
2
1
4-11-1 Comments
*
April 11 / Session 2
Update on FDA's Pre-Certification / Pavlovic
*
5
4
3
2
1
Pre-certification: Considerations / Calleja
*
5
4
3
2
1
Recent FDA Guidance / Mullen
*
5
4
3
2
1
4-11-2 Comments
*
April 11 / Session 3
Legislative Reform, VALID Act / Maloney
*
5
4
3
2
1
23andMe Story / Charter
*
5
4
3
2
1
Update on OIR Review Policy / Cleary
*
5
4
3
2
1
4-11-3 Comments
*
Please rate the overall event on the following using the same scale of 1 being poor to 5 being excellent:
Format & Organization
*
5
4
3
2
1
Time Frames
*
5
4
3
2
1
Facilities / Food
*
5
4
3
2
1
Overall relevance / Value
*
5
4
3
2
1
Please tell us your years of regulatory experience
*
Less than 1 year
1-5 years
6-10 years
11-15 years
16-20 years
20+ years
What suggestions for improvements or additions to the program would you offer?
*
What speakers/topics would you like to suggest for future programs?
*
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About
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