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Maximizing the Value of Literature Reviews in Pharma, From Competitive Intelligence to Market Success

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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 […]

IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR

Webinar

While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to the IVDD. Annex XIII of the IVDR specifies the contents of two new documents: the performance evaluation plan (PEP) and the performance evaluation report (PER). […]

It’s All Interconnected: Hidden Traps That Can Derail Your PER

Webinar

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a […]