At the beginning of the month, Criterion Edge’s Director of IVD & Scientific Writing Services, Dr. Sarah Chavez, alongside the VP of Sales & Marketing, Cheryl VanAllen, represented the company at the 16th Annual Q1 Productions Conference for IVD Clinical and Regulatory Affairs.
As the regulatory landscape evolves globally, this was an important conference for in vitro diagnostic (IVD) manufacturers and service providers to meet and discuss how to stay ahead of the curve to ensure compliance with new regulations. Criterion Edge discussed the EU IVDR and how it presents a significant challenge for regulatory and clinical affairs professionals in the diagnostic industry, as they must navigate a complex web of regulations across multiple regions, including the EU, UK, Switzerland, Canada, China, and the US.
At this event, Sarah and Cheryl attended case study presentations and panel discussions that covered the latest global regulatory changes and compliance strategies. They even focused on the growing concerns around cybersecurity breaches and how the diagnostic industry has also had to respond to new regulations aimed at maintaining cybersecurity standards. Overall, the conference offered a unique opportunity for diagnostic regulatory and clinical affairs executives to network and share knowledge, making it a fantastic networking and educational opportunity.
Join us on Wednesday, June 7th, 2023 at 11 AM PST, as our regulatory experts discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report.
Spots are limited – click to register for this free webinar.
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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