Laurie Mitchell, Criterion Edge President, and Kaylla Hall, Account Manager, joined leaders in life sciences medical communications at the 11th Annual Life Science Medical Communications Conference hosted by Q1 Productions in Boston last month. Together they shared their expertise and experiences on streamlining communication in healthcare. At this event, they participated in case studies and group discussions that covered a variety of topics, such as incorporating digital capabilities into publication operations, ensuring compliance in disease awareness communications, and developing effective engagement strategies for patients and external stakeholders.
Through discussions with industry professionals, they shared valuable insights on streamlining and enhancing medical communication operations with an emphasis on well-written plain language summaries for the lay audience and healthcare providers. Since the program hosted an intimate group, it fostered a sense of collaboration and allowed Laurie and Kaylla to connect with peers and expert presenters in a collaborative environment. Additionally, the networking opportunities brought Criterion Edge some great new connections that we are excited to partner with!
Laurie Mitchell, Criterion Edge President, and Kaylla Hall, Account Manager, joined leaders in life sciences medical communications at the 11th Annual Life Science Medical Communications Conference hosted by Q1 Productions in Boston last month. Together they shared their expertise and experiences on streamlining communication in healthcare. At this event, they participated in case studies and group discussions that covered a variety of topics, such as incorporating digital capabilities into publication operations, ensuring compliance in disease awareness communications, and developing effective engagement strategies for patients and external stakeholders.
Through discussions with industry professionals, they shared valuable insights on streamlining and enhancing medical communication operations with an emphasis on well-written plain language summaries for the lay audience and healthcare providers. Since the program hosted an intimate group, it fostered a sense of collaboration and allowed Laurie and Kaylla to connect with peers and expert presenters in a collaborative environment. Additionally, the networking opportunities brought Criterion Edge some great new connections that we are excited to partner with!
Click here to watch the recording of this webinar.
The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing that your IVD may be considered state of the art. Remember: the PER is a product, but it is documenting a process. Performance evaluation can be straightforward if your analyte has a well-established association with a clinical condition. But how should you approach the SVR when there is too much or not enough data?
This webinar will discuss the role of data sufficiency, the importance of developing a solid strategy to establish scientific validity, how gaps in the SVR can significantly impact the quality of the PER, and how proper scoping can help maximize success when it comes to a performance evaluation.
Key Takeaways
Who are the Panelists?
Sarah J. Chavez, Director, IVD & Scientific Writing Services, Criterion Edge
Sign up for future webinars here.
Criterion Edge has the expertise and resources to write your scientific validity report or performance evaluation report. Ready for a free consult?
Click here to watch the recording of this webinar.
Medical device manufacturers and pharma/biotech companies have a regulatory and legal obligation to convert key scientific content into plain language for lay audience consumption around the world. From producing clinical trial lay summaries for the general public to the action-focused informational content generation aimed at the Health Care Provider (HCP) audience, the need to produce a multitude of plain language written deliverables has strained many already-stretched internal teams. How can your organization meet these challenges?
Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients, caregivers, healthcare professionals (HCPs), and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all.
Content is the user experience. Make your words count.
Key Takeaways
Who are the Panelists?
Laurie W. Mitchell, President, Criterion Edge
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Click here to watch the recording of this webinar.
The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with up to 80% of IVDs requiring Notified Body certificates under IVDR.
In October 2022, the AAMI/FDA/BSI Annual Conference sought to discuss current knowledge and practical strategies to meet these new clinical evidence requirements. Dr. Sarah Chavez, Criterion Edge Director of IVD Writing Services, was honored to be an invited speaker and join with other regulatory, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”.
Attendees to this Criterion Edge webinar will benefit from key insider insights gleaned from this meeting, as Sarah will be share and discuss the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track. Most companies are in the early stages of planning for IVDR, so the goal of this webinar is to provide helpful suggestions for IVDR planning and preparation from the perspective of experienced regulatory writers.
Key Takeaways
Who Should Watch?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of performance evaluation reports for IVDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Director, IVD & Scientific Writing Services
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Click here to watch the recording of this webinar.
In September 2022, European Commissioners published updates to the Manual on Borderline and Classification for Medical Devices, which provides clarifications for classifying devices as medical or in vitro diagnostic devices under the MDR and IVDR. This guidance describes how to distinguish medical devices from medicinal products, biocides, and personal protective equipment, and how to distinguish between in vitro diagnostic medical devices and general laboratory equipment.
In this “Critical Concepts” webinar, we discuss rules for device classification under each regulation, as well as the risk-based classification rules as described in MDCH 2021-24 and MDCG 2020-16.
Key Takeaways
Who Should Watch?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.
Who are the Panelists?
President Laurie Mitchell
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
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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