February 22, 2023

[FREE WEBINAR] Plain Language Communication in Healthcare Part 1 Webinar

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

  • Key aspects that define plain language writing​
  • Plain language content writing for multiple audiences​
  • What is readability and suitability?​
  • The regulatory and legal requirements of plain language content​
  • Project planning for publication of Plain Language Summaries

Who are the Panelists?

Laurie W. Mitchell, President, Criterion Edge

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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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February 9, 2023

[FREE WEBINAR] New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference

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

  • What are the major changes from IVDD to IVDR?
  • How does IVDR define “Clinical Evidence,” and where can you find it?
  • What are the Notified Body’s expectations (and advice)?

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?

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September 3, 2022

Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process

Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process 

In the first part of our webinar series, we discussed Legacy Devices, WET devices, and devices exempt from Clinical Investigations under Article 61, along with the need for data sufficiency and how significant changes impact the route to conformity. In this webinar, our medical regulatory experts, Dr. Sarah Chavez and Stacie Beecham, discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We also discuss adjusting the Clinical Evaluation Plan to align with the regulatory strategy. 
 
How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? We answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device.

Click here to watch the recording of this webinar.

Who should register for this webinar?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions, or anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant.

How to Empower Data-Driven Decisions in Your Organization

Every day, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform, direct, and help drive their internal processes and decisions. Of course, to comply with global regulatory requirements, clinical literature is also required. Conducting SLRs to search, screen, and extract data from published sources can present challenges to your team in terms of expertise (e.g., medical librarian), methodology, and resources. It takes trained people with the availability to screen, review, and analyze the literature.

Download our free white paper, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic.

You can also watch our webinar on this topic.

Our President Laurie Mitchell joins Jennifer Tetzlaff, Research Product Specialist with Evidence Partners, to talk to you about the following points:

  • Examples of how the use of published data can support regulatory expectations
  • When to conduct a systematic literature review
  • Best practices for conducting a methodologically-sound SLR
  • Use of available tools and technology
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July 28, 2022

Bridging the Gaps: Clinical Data for GSPRs

Bridging the Gaps: Determining Clinical Data Sufficiency to Demonstrate Conformity with GSPRs

What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists and the device meets specific criteria. In this webinar, we will discuss the concept of clinical data sufficiency. Specifically, we will explain the differences between a well-established technology and a legacy device as defined by MDR, and discuss strategies from both a regulatory and writer’s perspective.

Click here to watch the recording of this webinar.

There will be time at the end of the webinar to get your questions answered. Please submit any questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may also send in your questions during the webinar.

Who should register for this webinar?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions, or anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant.

How to Empower Data-Driven Decisions in Your Organization

Every day, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform, direct, and help drive their internal processes and decisions. Of course, to comply with global regulatory requirements, clinical literature is also required. Conducting SLRs to search, screen, and extract data from published sources can present challenges to your team in terms of expertise (e.g., medical librarian), methodology, and resources. It takes trained people with the availability to screen, review, and analyze the literature.

Download our free white paper, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic.

You can also watch our webinar on this topic.

Our President Laurie Mitchell joins Jennifer Tetzlaff, Research Product Specialist with Evidence Partners, to talk to you about the following points:

  • Examples of how the use of published data can support regulatory expectations
  • When to conduct a systematic literature review
  • Best practices for conducting a methodologically-sound SLR
  • Use of available tools and technology
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December 20, 2017

EU MDR and Clinical Evidence: What You Need to Know

“One of the key objectives of the new EU MDR is to ensure a high level of health and safety protection for EU citizens. Making clinical investigation and evaluation requirements more stringent is aimed at improving health and safety through transparency and traceability.”

 

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[Free Webinar] IVDR Readiness: Creating a Blueprint to Build a Strong PER

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.

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