IVDR Implementation: Key Considerations Amidst the Looming Deadline



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Monthly Program event 'co-organized' by SDRAN and OCRA


IVDR Implementation: Key Considerations Amidst the Looming Deadline


Program Speaker:


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


FLYER

Event Agenda:

Date: Wednesday, 18 Aug 2021

Time*:


5:30 - 5:40 PM Introductions

SDRAN- Sasi Mudumba

OCRA-Tommi Papson

5:40 – 6:25 PM TJ Presentation: MDR/IVDR comparison, PERs, and post marketsurveillance

6:25 – 7:10 PM Count-down to implementation, pitfalls and best practices

7:05 – 7:30 PM Q&A, hot topics panel

Program Topic:


As the IVDR implementation looms closer this program will provide valuable feedback and lessons learned from two thought leaders that are working closing for 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

Speaker Biography:

Gail Gasior, CCRA, RAC, RQAP-GCP

Director, Clinical Compliance, Diagnostic Solutions Division, Hologic, Inc.

I have 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).

I lead 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.


Location:

Not applicable - This is an online event

Online registration (ends 17Aug2021): $15 SDRAN Member

$15 OCRA Member

$20 Non-Member

For Questions Email: programs.committee@sdran.org