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IVDR Implementation: Key Considerations Amidst The Looming Deadline

August 18 @ 5:30 pm - 7:30 pm UTC-7

$10 – $15

Speakers:

  • Gail Gasior, CCRA, RAC, RQAP-GCP, Director, Clinical Compliance, Diagnostic Solutions Division, Hologic, Inc.
  • Terrance (TJ) Thiel, RAC, Director and Principal Consultant / Consulting Operations Brandwood CKC

Program Manager: Luis Jimenez, MBA, OCRA Past President, 2020

 

Synopsis:

As the IVDR implementation looms closer this program will provide valuable feedback and lessons learned from two thought leaders that are working closely on multi-product IVDR certifications. The program will address most recent developments of IVDR, including a status update about notified bodies and implementation deadlines. We will address possible points of confusion between MDR and IVDR as well as share best practices and pitfalls to avoid.

Topics will include:

  • Count-down to implementation
  • Guidance and Feedback for Notified Bodies
  • Pitfalls and best practices
  • IVDR to MDR Comparison
  • Performance Evaluation Reports
  • High-Risk Product and Product Batch Release requirements
  • Hot Topics Panel & Q&A at the End

Cost:

  • OCRA & SDRAN Members: $15
  • Non-Members: Register through SDRAN for $20,
  • Government and Student Members: $10, with student/government ID

 

Speaker Bios

 Gail Gasior, CCRA, RAC, RQAP-GCP, Director, Clinical Compliance, Diagnostic Solutions Division, Hologic, Inc.


Gail Gasior has 25 years of experience in in-vitro diagnostics clinical trial conduct, design and oversight. The last eleven years I have led the Clinical Compliance function at Hologic (formerly Gen-Probe)

She leads the ongoing development and oversight of a robust Clinical Quality Management System to ensure that Clinical Affairs activities are in accordance with company policies and procedures, applicable current laws, regulations and guidelines. I collect and disseminate clinical regulatory intelligence by participating in industry and regulatory working groups and by working with divisional and corporate policy committees. I participate on the AdvaMed Clinical Trial Working Group on topics relevant to IVDs, and the MedTech Europe Clinical Evaluation Working Group. I sat on the ISO Working Group that developed and recently published the new standard ISO 20916, In vitro diagnostic medical devices – Clinical Performance Studies using specimens from human subjects – Good study practice

     

Terrance (TJ) Thiel, RAC, Director and Principal Consultant / Consulting Operations Brandwood CKC

TJ Thiel has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches. TJ has prepared, submitted and achieved significant approvals for medical devices – including active implantables (AIMDs), implantables and Software as Medical Device (SaMD) – and in vitro diagnostics including point-of-care, self-testing and laboratory devices.  TJ holds Regulatory Affairs Certification (RAC) and has delivered regulatory approvals including FDA 510(k), PMA and De Novo; CE-marking; Health Canada; TGA; PMDA and NMPA.

 

Program Manager: Luis Jimenez, MBA, OCRA Past President, 2020

 

OCRA Registration Instructions

It is important that you register with the name and email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.

Certificates of attendance will be emailed within two weeks of the event.

If you would like a certificate of attendance from SDRAN, please e-mail [email protected] with your full name and include Certificate of Attendance in the subject line.

 

Registration deadline is August 17th at noon.

OCRA’s non-profit Federal Tax ID# 33-0630455

 

If you have any questions or require additional information, email OCRA Program Chair ([email protected]).

Photo by National Cancer Institute on Unsplash

Details

Date:
August 18
Time:
5:30 pm - 7:30 pm UTC-7
Cost:
$10 – $15
View Event Website

Venue

Webinar