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How to Prepare for the IVDR
Wednesday 14 August 2019, 04:00pm - 07:30pm
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Contact OCRA Program Chair

 

You are invited to an Evening Meeting

 

Networking and Educational Opportunity

 

How to Prepare for the IVDR

A review of the new IVDR regulatory requirements, how notified bodies will verify compliance to the IVDR, and how local IVD companies are preparing for the IVDR transition.

 

August 14, 2019

4:00 – 7:30 pm

 

Join In Person or On Webinar

 

Online Registration: https://www.eventbrite.com/e/are-you-ready-for-the-ivdr-tickets-65489305275

 

3 Hours Towards Your RAC Recertification

 

Location:  

HORIBA Medical, 9755 Research Drive, Irvine, CA 92618

 

Host:

Azita Hedayati, MS, CMQ/QE, CQA, Director, Regulatory & Compliance, HORIBA Medical

 

Program Managers and Moderators:

Rowena Soriano, Regulatory Affairs Specialist, Bio Rad

Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant

 

Presenters and Panelists:

Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant

Julien Senac, Ph.D. Global Director, IVD Focus Group, TÜV SÜD

Annette Hellie, RAC, Sr. Manager Regulatory Affairs, Beckman Coulter

Tara Viviani, RAC, Director of Regulatory & Clinical Affairs, Hycor Biomedical

 

Schedule of Presentations:

 

4:00 – 4:30 pm           Registration, Networking, and Refreshments

 

4:30 – 5:00 pm           Overview of IVDR and New IVD Classifications Speaker – Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant, Kim Walker Consulting

 

5:00 – 5:45 pm           How Notified Bodies Will Verify IVDR Compliance Speaker – Julien Senac, Ph.D. Global Director, IVD Focus Group, TÜV SÜD

 

5:45 – 6:00 pm           Break, Networking, and Refreshments

 

6:00 – 6:45 pm           Case Study:  Beckman Coulter’s IVDR Transition Project Speaker – Annette Hellie, RAC, Sr. Manager Regulatory Affairs, Beckman Coulter

 

6:45 – 7:30 pm           Q&A, Panel Discussion (Small vs. Large Company Implementation Discussion), and Closing Remarks

 

Synopsis:

We will review the new In Vitro Diagnostic Regulation (IVDR), including classifications, performance evaluations, technical files, and discuss what has changed. Additionally, we will discuss how notified bodies plan to support companies implementing IVDR and how companies can manage a smoother transition to the new regulations.

 

Please join us for these learning opportunities and open discussions with seasoned industry and notified body professionals.

 

Cost:

OCRA Members: $60 in-person attendance or $40 webinar* attendance

Non-Members: $135 in-person attendance or $115 webinar* attendance (includes OCRA Membership fee)

Government and Students in-person attendance: $35 for members or $70 for non-members (includes OCRA Membership fee)

Government and Students webinar attendance:  $20 for members or $55 for non-members (includes OCRA Membership fee)

FREE for HORIBA Medical Employees (please email program host to be added to the list)

 

If you have any questions or require additional information, email OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.).

 

Registration deadline is August 13th.  No same day (in-person or webinar) or on-site registrations will be allowed.  You must register for this event using EventBrite:  https://www.eventbrite.com/e/are-you-ready-for-the-ivdr-tickets-65489305275

 

*Webinar attendees: Email This email address is being protected from spambots. You need JavaScript enabled to view it. by August 13th for a link to the webinar.

 

Speaker Bios

 

Dr. Julien Senac is currently Global Director of the IVD Focus Team at TÜV SÜD. Prior to this, he has many years of experience with a certification body, where he participated to the preparation of IVDR designation, and performed Design Dossier assessment of in vitro diagnostic devices.  Dr. Senac has a Ph.D. in Molecular and Human Genetics from Baylor College of Medicine (Houston, TX) and more than 10 years of experience in biomedical research. He worked in top research/medical institutions in the United States such as Mayo Clinic and the National Institutes of Health. Dr Senac has also participated to the development of multiple biotech start-up companies in oncology, gene therapy, and AIDs technologies.                                          

 

Annette Hellie is Sr. Manager of Regulatory Affairs at Beckman Coulter. Ms. Hellie leads Beckman Coulter’s Regulatory Affairs team for its Chemistry product line, which include reagents, instruments, and supporting devices. In addition to Regulatory Affairs leadership, she is also a member of Beckman Coulter’s cross-functional Operational Leadership Team, which sets and guides the Chemistry business overall strategic direction. She is also part of a multi-functional business unit IVDR core team with a charter to ensure consistency across the business groups. Ms. Hellie began her career at Beckman in 1990 as a Scientist in Reagent Development before moving in to Regulatory Affairs.

 

Tara M. Viviani, RAC (US) (This email address is being protected from spambots. You need JavaScript enabled to view it.) is a Director of Regulatory Affairs and Clinical Affairs at HYCOR Biomedical.  Ms. Viviani has more than 29 years of experience in the medical device industry with 19 years of experience in Regulatory and Clinical Affairs.  Her background includes positions in Quality, R&D, and various positions in Regulatory Affairs.  Her Regulatory Affairs roles have included responsibilities for global pre-market and post-market and global regulatory affairs.  She has successfully authored many types of US pre-market submissions including 510(k), Emergency Use Authorizations (EUA), IDE applications, and de novo petitions.  Tara actively participates in industry groups.  She has been a member of AdvaMed Working Groups; and she has been a speaker and a panelist at OCRA educational events.  Tara has also served as a mentor for regulatory associates through the OCRA mentoring program.  She holds a RAC (US) certification and earned her Bachelor’s of Science in Biological Science from University of California at Irvine.

 

Kim Walker, MS, RAC (US & EU), FRAPS is an independent Global Regulatory Affairs and Quality Assurance Consultant and owner of Kim Walker Consulting since 2006.  In her consulting practice, she assists clients with pre- and post-market regulatory, clinical, and quality system needs.  Kim has served on the OCRA Program Committee since 2003 and, currently, serves as the Program Chair.  Additionally, she served on the OCRA Board of Directors 2004-2010, 2019 and was the 2008-2009 President.  Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups and was listed as one of the authors for CLSI GP22-A3. Quality Management System: Continual Improvement.  She also has participated in the SDRAN Mentoring Program since 2009.  Kim participated on the CSUPERB Advisory Committee and Development Team for the Project Management in Clinical Trials certificate program through CSUF and, also, served as an instructor.  Kim was also an instructor for the “Regulatory Requirements for Pharmaceutical Products” course and a co-instructor for the “Technical Writing for the Medical Product Industry” course at UCI Ext.  She re-developed and currently teaches the “Medical Device Regulations” course for the SDSU Master of Science in Regulatory Affairs program. Kim developed and has taught an undergraduate “Medical Product Regulations: Bench to Bedside” course at CSUF with a focus on stem cell therapies since 2016.  She achieved both the US and EU RAPS Regulatory Affairs Certifications and has been accepted as a RAPS Fellow in recognition of her contributions and leadership in advancing the regulatory profession.  Additionally, Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development.  She has a BS in Bio-Medical Sciences and MS in Regulatory Affairs. 

 

 

OCRA Registration Instructions

 

In-person registration fee includes light snacks, beverages, free parking and access to electronic presentations after the meeting (if approved by speaker for distribution).    

 

To register for this event go to: https://www.eventbrite.com/e/are-you-ready-for-the-ivdr-tickets-65489305275

 

Registration deadline is August 13th.  

 

No same day (in-person or webinar) or on-site registrations will be allowed. 

 

*Webinar attendees: Email This email address is being protected from spambots. You need JavaScript enabled to view it. by August 13th to obtain a link to the webinar.

 

 

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

 

 

Cancellation Deadline:

For a refund, please email your cancellation request to OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.) by August 7, 2019.

 

If you have any questions or require additional information, email OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.).

 

 

 

 

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