SOLD OUT – EU In Vitro Diagnostics Regulations (IVDR)

When:  Jun 9, 2020 from 9:00 AM to 5:00 PM (ET)

In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as a virtual program. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.


With the May 2020 deadline approaching, have you started early enough to understand the new IVD requirements and meet these new expectations? Are you generating the right data to comply with the increased notified body review and scrutiny? 

Featuring hands-on practical exercises, this virtual workshop will connect you with leading IVD regulatory experts. Through interactive exercises you will learn how regulatory professionals are currently planning and working towards achieving full compliance by 2022. This two-day virtual workshop is an invaluable opportunity to share experiences, learn from experts and peers, as we all prepare to fully comply with new regulations. Regulatory professionals responsible for achieving IVDR compliance for legacy CE IVDD products and new IVDs intended for the European Market will find this RAPS workshop especially rewarding.    

Registration Closes:  2 June 2020 
Refund Deadline:  16 May 2020*

*Please see the cancellation policy below.

RAC Credits:  12 (Upon attending and completing the program)

Will the meeting be recorded?  No

Registration to 10 May 2020 
RAPS Members: $800
Nonmembers: $900

Registration from 11 May to 8 June 2020 
RAPS Members: $900
Nonmembers:  $1,000

NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early.  

Program Schedule 
Tuesday, June 9 (9:00am–5:00pm) 

Topics will include (but not limited to): 

Key issues and developments related to EU IVDR and timelines
Classification changes and case studies
Conformity assessments and Notified Bodies readiness
Technical documentation expectations: labeling and unique device identifications (UDI)
Creating a transition strategy for legacy devices: from IVDD to IVDR

Wednesday, 10 June (9:00am-5:00pm) 
Clinical evidence/performance reports (PER) and perspective on in-house tests
Post-market surveillance (PMS) and post-market performance follow-up (PMFP)
Economic operators: EUDAMED 
Preparing for the unknown


NOTE: The agenda may vary based on changing requirements.

Faculty 
Sue Spencer, head of in vitro diagnostics and principal consultant, Qserve Group UK, Ltd. 


Cancellation or Substitutions 

RAPS reserves the right to cancel this program at its sole discretion. 

All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived.  Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months.

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.  Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event. 

Proof of Attendance
RAPS will send an electronic letter or a certificate of attendance upon request.

Questions
Call RAPS Solutions Center at +1 301.770.2920, Ext 200

Other Information

Registration Form 
If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer.

Program Contact
Nichelle Sankey
nsankey@raps.org
+1 301 770 2920, Ext 291