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ISO 14155:2020 – Clinical Trial Requirements Have Changed

November 24 @ 11:00 am - 12:30 pm UTC-7

Location:  Webinar 

 

Program Manager:

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

 

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

 

The Final Draft of the ISO 14155 has 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.

 

Cost:

OCRA Members: $25

Non-Members: $100, includes 1-year OCRA membership

Government and Student Members: $10, with student/government ID

Non-Member Government and Student Rate: $45, includes 1-year OCRA membership

 

Speaker Bios

 

Danielle Giroud
Founder, CEO MD-Clinicals & WMDO

 

With over 30 years of experience within the medical device industry, Ms. Danielle Giroud is founder of MD-Clinicals (https://www.md-clinicals.com), a purely medical device-focused CRO with offices in Switzerland, Frankfurt, and Beijing.

 

Ms. Giroud is regarded as an internationally recognized clinical research and regulatory expert, having shared her extensive knowledge and experience with hundreds of multi-national companies, organizations, and start-ups from around the globe to help bring their products to market quickly and efficiently.

 

She is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (https://www.wmdo.org), as well as convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155, and liaison with the EU Commission – Clinical Investigation and Evaluation (CIE) task force and other regulatory authorities throughout the world.

www.md-clinicals.com

www.wmdo.org

 

 

 

 

OCRA Registration Instructions:

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

 

Registration deadline is November 23rd

No same day registrations will be allowed.

Certificates of attendance will be emailed within a day of the event. OCRA’s non-profit Federal Tax ID# 33-0630455

 

Cancellation Deadline:

For a refund, please email your cancellation request to OCRA Program Chair ([email protected]) by NOV 17, 2020.

 

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

Details

Date:
November 24
Time:
11:00 am - 12:30 pm UTC-7
Website:
https://ocra-dg.org/event/iso-141552020-clinical-trial-requirements-have-changed/

Venue

Webinar