EU Clinical Trial Regulation (CTR) and Clinical Trials Information System (CTIS)

Program Speaker: 

Theresa Falls

Manager of Regulatory Affairs

Avidity Biosciences, Inc.

Event Agenda:

DATE: Wednesday, 20 March 2024

TIME: 6:00 – 6:05 PM Welcome and Announcements  

           6:05 – 7:05 PM Program Presentation

            7:05 – 7:30 PM Q & A

LOCATION: This event is being offered virtually. The zoom link will be shared with you via email 1-2 days before the event. 

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Program Topic:

The Clinical Trials Regulation (CTR) has been in effect in Europe since January 2022, but it has only been a year since clinical trial applications have been required to be submitted through the Clinical Trials Information System (CTIS). In this talk, I will present overview of the implementation, best practices and strategic considerations to work in the harmonized system for clinical trials in Europe.

Speaker Biography:

Theresa Falls has over 18 years of experience in hospital/academia, biotechnology startup, and industry research settings in Canada and the United States, and has worked with global CROs, consultants, and vendors supporting GxP studies. Her early stage career focused on preclinical roles in the translational research setting, encompassing discovery to clinical delivery, for the development of biologics targeting human diseases. In such roles, she has gained experience in both the veterinary and human clinical settings including ethics committees, biorepositories, GxPs, and GLP study execution in disease areas such as oncology and rare diseases. Currently, Theresa works as a Manager of Regulatory Affairs at a local San Diego biotechnology with expertise supporting global program strategy and regulatory submissions for Phase I-III clinical trials with a focus on rare diseases. She holds a diploma in Veterinary Technology, a B.Sc. Honours in Biopharmaceutical Science, with specialization in genomics (both Canada), and a Master of Science in Regulatory Science as well as project management certificate (US).

Registration Information:

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Contact

[email protected]

Pricing – Online – Registration (ends March 19, 2024)

Cancellation Policy

There will be no refunds for cancellations.