From May 2022 onwards, clinical trial assays being developed as companion diagnostics (CDx) need to meet the requirements of the European Union In Vitro Diagnostics Regulation (EU IVDR; Regulation (EU) 2017/746 (EU IVDR)), which includes more stringent oversight during the clinical performance study (CPS) phase of development.
This raises challenges for global CDx trials that contain EU subject recruitment sites, especially with the delay in the full implementation of the European Database on Medical Devices (EUDAMED) and its clinical investigations and performance studies module.
The clinical investigations and performance studies module is still not functional (as of early 2024); consequently, CPS applications and corresponding ethics committee reviews must be submitted to each competent authority and ethics board, which then necessitates co-ordination across multiple jurisdictions in the EU for trials recruiting across multiple EU countries. This can add significantly to the trial set-up time for interventional and registrational in vitro diagnostics (IVD) trials incorporating EU sites.
In this webinar, the expert speakers will focus on their experience with IVDR and describe strategies for solving the specific challenges faced during the IVDR submission process for clinical trial assays being utilised as CDx, allowing global trials to commence and complete in a timely manner.
Register for this webinar today where experts will share their experience with the EU IVDR and provide insights into solving challenges faced during the EU IVDR submission process.
Speakers
Dr. Stewart McWilliams, Global VP Quality and Regulatory Affairs, Almac Diagnostic Services
Stewart McWilliams leads the Quality Management and In vitro Diagnostic Regulatory affairs activities at Almac Diagnostics. The team works with the pharmaceutical industry on the Quality and Regulatory aspects of CDx Development and Commercialisation. This team is also responsible for Almac Diagnostics’ Laboratory Quality Management systems ensuring compliance with ISO13485, CLIA (Federal and New York State CLEP), ISO17025, ISO15189 and the College of American Pathologists accreditation requirements.
Stewart studied at Queen’s University Belfast where he attained his degree and PhD in Molecular Oncology, and then did his postdoctoral work at The Wellcome Trust Centre in Dundee. Stewart has managed the implementation of various quality management systems, including ISO13485, ISO17025, GCP, CAP accreditation, New York State CLEP and CLIA. He is also the Almac Diagnostics Designated Individual for the UKs Human Tissue Act and the Person Responsible for Regulatory Compliance (PRRC) under IVDR.
Message Presenter
Dr. Charlene Robb, IVD Regulatory Affairs Team Leader, Almac Diagnostic Services
Charlene studied at Queens University Belfast where she attained a Masters degree in Pharmacy and a PhD in Molecular Therapeutics. She then continued at the university working as a post-doctoral research fellow developing novel in vitro diagnostic devices (IVDs) for the detection of active proteases. These IVDs became the basis of a spin-out company, ProAxsis, where she worked as a Regulatory Affairs Scientist developing the company’s Quality Management System and ensuring regulatory compliance. Charlene has also worked as a lecturer in Regulatory Affairs for China Medical University. Charlene joined Almac Diagnostic Services’ regulatory team in 2019 and has since been responsible for developing and implementing regulatory strategies for IVDs and companion diagnostics within global clinical trials.
Message PresenterWho Should Attend?
This webinar will appeal to senior pharma/biopharma professionals in the following fields:
- Biomarker discovery
- Translational medicine
- Clinical development
- CDx development
- Regulatory affairs
What You Will Learn
Attendees will learn about the following:
- Challenges associated with the EU IVDR regulation
- Solutions to help overcome some IVDR hurdles for global clinical trials
- Key considerations when planning for CDx trials with EU sites
- Where to look for key information required for CPS submissions
- EU country-specific regulatory intelligence
Xtalks Partner
Almac Diagnostics Services
Your global partner for biomarker discovery, development & commercialisation.
Almac Diagnostic Services supports global pharma and biotech companies with their biomarker strategies from discovery through to companion diagnostic partnerships.
We have clinical and research laboratories in Europe and the USA, alongside strategic partnerships in China, enabling us to support global studies.
The core services we offer fall into three main categories:
- Genomic Services
- Clinical Trial Assays
- Companion Diagnostics
Click here to find out more.
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