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ISO 14155:2019 - Clinical Trial Requirements Have Changed
Wednesday 19 June 2019, 05:00pm - 08:00pm
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You are invited to an Evening Meeting

 Networking and Educational Opportunity

ISO 14155:2019 - Clinical Trial Requirements Have Changed

A review of the changes to and practical applications of these changes in the new 2019 version of ISO 14155 - Clinical investigation of medical devices for human subjects - Good clinical practice.

June 19, 2019
5:00 – 8:00 pm

Join In Person or On Webinar

Online Registration: https://www.eventbrite.com/e/ocra-iso-141552019-clinical-trial-requirements-have-changed-tickets-62331307619


| 3 Hours Towards Your RAC Recertification |

 

Location:  

CSA Group
34 Bunsen, Irvine, CA 92618

 

Host:

Calvin Luong, Product Group Manager, CSA Group

Program Managers and Moderators:

Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant, Kim Walker Consulting
Fatima Naseer, MPharm, Regulatory Affairs Specialist, FUJIFILM Irvine Scientific

 

Invited Presenter:

Danielle Giroud, CEO, MD-Clinicals, Convener for the Expert Group on Clinical Investigations (TC 194 WG4 for the ISO 14155), & Liaison with the EU Commission - CIE (Clinical Investigation and Evaluation) Task Force

 

Schedule of Presentations:

 

5:00 – 6:00 pm           Registration, Networking, and Refreshments

 

6:00 – 7:30 pm           Review of ISO 14155:2019 Changes

Speaker – Danielle Giroud, CEO, MD-Clinicals, Convener for the Expert Group on Clinical Investigations (TC 194 WG4 for the ISO 14155), & Liaison with the EU Commission - CIE (Clinical Investigation and Evaluation) Task Force

 

7:30 – 8:00 pm           Q&A Discussion and Closing Remarks

 

Synopsis:

The Final Draft of the ISO 14155 has just been released. The standard has many areas that are updated significantly. The update came from various sources besides continuous improvement, increased risk based approach (both for the investigational device – ISO 14971 as well as regarding the conduct of the clinical investigation itself), EU MDR, a stronger need for study design including statistical aspects, defining types of clinical investigations, and how ISO applies to each of them.  Many subject matter experts have contributed to the many changes in this version of the standard.  This workshop will provide you with an overview of the main changes, bring important information on the conduct of international clinical investigations, and how the standard concurs with the new EU-MDR requirements for clinical investigations.

 

Please join us for this networking and learning opportunity and open discussions with seasoned industry professionals.

 

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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: $35 for members or $70 for non-members (includes OCRA Membership fee)

FREE for CSA Group 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 June 18th.  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/ocra-iso-141552019-clinical-trial-requirements-have-changed-tickets-62331307619

 

*Webinar attendees: email This email address is being protected from spambots. You need JavaScript enabled to view it. by June 18th to obtain a link to the webinar.

 

Danielle Giroud RN, MBA

Founder, WMDO & MD-CLINICALS

With over 30 years of experience, Ms. Giroud is founder of the World Medical Device Organization, an independent professional organization dedicated, to serving the professional development and educational needs of medical device professionals.

Since 2013, Mrs. Giroud also founded MD-CLINICALS, a 100% medical device full service dedicated CRO with main activities in the Asia Pacific region and Europe.

Mrs. Giroud is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO 14155 as well as liaison with the EU Commission - CIE (Clinical Investigation and Evaluation) task force.

 

www.wmdo.org // www.md-clinicals.com

 

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/ocra-iso-141552019-clinical-trial-requirements-have-changed-tickets-62331307619

 

Registration deadline is June 18th

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 June 18th 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 June 12th, 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.).

 

 

Location CSA Group
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