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ISO 14155:2020 – Clinical Trial Requirements Have Changed
November 24 @ 11:00 am - 12:30 pm UTC-7
Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant
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.
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
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.
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
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]).