AM Evaluation

2019 AMDM Annual IVD Regulatory Meeting Evaluation

April 10 / Session 1

IVD Industry Overview / Kahan *

Real World Evidence... / Bush *

4-10-1 Comments *

April 10 / Session 2

Roundtable with OIR Management Team *

Breakthrough Designation / Vietz *

Diabetes Update / Silk *

CLIA Waiver / Kondratovich *

Successful Submissions for POC / Perez-Torres *

CLIA Waiver / POC Diagnostics / Boiani *

IVD Vigilance / Cowan *

4-10-2 Comments *

April 11 Session 1

Facing IVDR Challenges Panel *

4-11-1 Comments *

April 11 / Session 2

Update on FDA's Pre-Certification / Pavlovic *

Pre-certification: Considerations / Calleja *

Recent FDA Guidance / Mullen *

4-11-2 Comments *

April 11 / Session 3

Legislative Reform, VALID Act / Maloney *

23andMe Story / Charter *

Update on OIR Review Policy / Cleary *

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 *

Time Frames *

Facilities / Food *

Overall relevance / Value *

Please tell us your years of regulatory experience *

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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