In this webinar, we will explore the strategic use of Real-World Evidence (RWE) throughout product development. Participants will learn about the integration of RWE from various sources and how it can be used to bolster regulatory submissions. Learning Objectives: Understand the sources of Real-World Data (RWD) which are used to generate RWE Explore the main […]
Join us for an insightful and interactive webinar where we explore the ever-evolving landscape of global regulatory trends and their impact on information across all industries. As regulations governing product development, agency interactions, and filing for product approvals become increasingly complex and geographically diverse, regulatory professionals and medical writers must adapt to ensure the compliance, […]
Welcome to our Ask The Expert series, where the Criterion Edge team of experts take your questions on trending industry topics relevant to the work you do every day. From global regulatory challenges, clinical evidence issues or regulatory writing best practices, the goal of this Q&A format is to share information, ideas and solutions. Today’s […]
Writing is not an innate talent, but a learned skill requiring extensive training and practice. Scientific writing is no exception. As scientists, we have all seen examples of how bad writing and ineffective communication can detract from good science. The goal of this presentation is to describe strategies to support effective partnerships between regulatory experts […]
Real world evidence is increasingly important for companies seeking to demonstrate device performance without the time and expense of extensive clinical trials. This webinar will explore how to effectively use real-world evidence in regulatory submissions to accelerate product approvals and meet post-market surveillance requirements. Learning Objectives: Summarize recent regulatory guidance pertaining to the use of […]
Overview In the fast-paced environment of pharmaceutical development, project demands often outstrip available resources, leading to critical bottlenecks in deliverables. Teams frequently find themselves finishing one clinical study and needing to pivot to the next project development, leaving tasks like CSR completion sidelined. Additionally, competing priorities, from regulatory requirements to study design revisions, can push […]
Overview Understand the intricacies of the FDA’s Pre-Determined Change Control Plan (PCCP) and its application across medical devices and in vitro diagnostics (IVDs). This webinar is designed for global regulatory and quality professionals aiming to streamline their strategies for managing post-market device modifications. Attendees will walk away with a deeper understanding of regulatory changes and […]
Here we are, nearly eight years after the publication of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and Medical Devices Regulation (EU) 2017/745 (MDR). As the May 2025 deadlines loom, many manufacturers are facing the reality of what implementing these regulations actually entails. While the manufacturers seem to have been given more […]
A well-executed systematic literature review (SLR) is more than just a regulatory compliance requirement—it’s a strategic asset for your entire organization. In this webinar, we’ll explore how a good SLR can support regulatory submissions, enhance competitive intelligence, and facilitate post-market surveillance while saving time, money, and resources. Using real-world examples, our experts will share best […]
A well-executed systematic literature review (SLR) is more than just a regulatory compliance requirement—it’s a strategic asset for your entire organization. In this webinar, we’ll explore how a well-designed systematic literature review can support regulatory submissions, enhance competitive intelligence, and facilitate post-market surveillance while saving time, money, and resources. Using real-world examples, our experts will […]
Artificial intelligence and large language models (LLMs) are transforming how medical device companies approach regulatory writing, but questions remain around how to implement these tools effectively and responsibly, and whether they actually save time and improve productivity. In this Ask the Expert session, the team at Criterion Edge will explore how AI and LLMs can […]
In the pharmaceutical industry, systematic literature reviews (SLRs) can be a valuable tool — not just for regulatory submissions, but as a strategic foundation for drug development, clinical trial design, and commercialization, feasibility, supporting IND/NDA filings, and identifying unmet needs. Understanding the full scope of their strategic value can help teams align evidence generation with […]
