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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
As scientific literature continues to grow, traditional systematic literature reviews (SLRs) can leave valuable insights siloed in individual reports. AI-powered evidence intelligence can help life sciences teams make scientific evidence more accessible, reusable, and actionable across the organization. In this webinar, our experts explore how pharmaceutical and medical device companies can combine AI, systematic literature […]
AI is becoming increasingly common in scientific and regulatory writing, but using it effectively requires more than simply automating existing workflows. In regulated environments, teams must balance AI-driven efficiency with scientific judgment, evidence traceability, quality control, and human accountability. In this webinar, Criterion Edge explores a human + AI approach to scientific and regulatory writing, […]
