VENUE: CityWest Hotel Dublin
DATE: Thursday 4th 2017
08:30-09:00
Registration/tea/coffee
09:00-09:30
Chairs welcome/ Keynote Address (ARC)
09:30-10:00
Presentation 1: Overview of regulation (To be confirmed)
10:00-10:30
Presentation 2: Changes from a Notified Body Perspective (Susan Murphy, NSAI)
10:30-10:45
Panel Discussion (ARC/ NSAI)
10:45-11:00
Tea/Coffee/ & Networking
11:00-11:45
Presentation 3 & Workshop - Assessing the Impact of the changes (ARC presents & facilitates)
11:45-12:00
Discussion on assessing the impact
12:00-12:30
Presentation 4 – Standard Development: Key to market knowledge & access (Linda Hendy, NSAI & ARC)
12:30-13:30
LUNCH & Networking
13:30-13:50
Presentation 5 - Additional Regulations: Biocidals, REACH (BIVDA
13:50-14:10
Presentation 6 – General Data Protection Regulation (To be confirmed)
14:15-14:45
Presentation 7 – Large Manufacturer Case Study (To be con rmed)
Workshops - 14:45-16:15
Stream 1
(General IVD's) - Led by Sue Spencer, UL (Notified Body)
Stream 2
(Companion Diagnostics) - Led by Seamus Kearney, ARC Regulatory
Stream 3
(LDT's) - To be confirmed
(Registration required for these workshops)
16:15
Wrap up