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North Carolina Regulatory Affairs Forum

NCRAF is an association of regulatory affairs professionals centered in the Raleigh-Durham-Chapel Hill "Triangle" of North Carolina USA. NCRAF is dedicated to providing education and support for the continuing professional development of individuals who have an interest in regulatory affairs activities as they apply to research, development, or manufacture of drugs, biologics, or medical devices.

 The first meeting of the 2023 Year!

February 16, 2023

The EU Clinical Trials Regulation implementation

Kirsten Messmer, PhD, RAC


The Clinical Trial Regulation came into application in Europe on January 31, 2022. More importantly since January 31, 2023, ALL NEW clinical trials need to be submitted through the new Clinical Trials Information System.

This regulation harmonizes clinical trial applications throughout Europe and aims to create a favorable research environment for medicinal product development. The Clinical Trial Directive which is still applicable for already ongoing trials until January 2025, created a patchwork of national clinical trial requirements. Although national requirements still apply, the Clinical Trial Regulation simplifies the application process by providing a one-stop E.U. portal, the Clinical Trial Information System (CTIS), for clinical trial submissions and management. This allows for a single clinical trial application submission to all targeted E.U. and E.A.A. countries.

The presentation will discuss the clinical trial landscape in Europe. We’ll also address some questions around the implementation and update such as: How has the Clinical Trial Regulation application and CTIS use worked out over the last year? Did the system work as advertised and tested? Were there glitches in the use of the system? What impact did the new implementation deadline have?

 

Networking: 5:30 - 6:30 pm EDT.
Seminar: 6:30 - 7:30 pm EDT


NEW LOCATION
IQVIA at Innovation Park,
2400 Ellis Road, Durham, NC, 27703

REGISTER

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Registration for the 2022 RAC Workshops is still OPEN!!

You must be a member to register. Workshop registration is $75

Live sessions were held from June-September and are now complete.

Recordings of all sessions are still available.  

REGISTER for Device Workshop
REGISTER for Pharm-Bio Workshop

 

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Membership dues for 2022 will continue to be $20 for the year.

When your membership renewal comes up during the 2022 calendar year, you will receive, via email,
an invoice for $20.
Please pay via the invoice (there's a link in the email),
the old "log in to the website and renew" is no longer available.


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