Watch as experts in Regulatory CMC from Veristat delve into critical topics, addressing key challenges, outlining effective strategies, and highlighting important considerations for analytical programs aimed at demonstrating comparability.
Gain insight from regulatory experts regarding unmet medical needs, accessibility and affordability, the competitive and innovative European pharma industry, enhancing resilience, and the EU’s global voice.
Explore the challenges of designing and running an extraordinary complex natural history study - with both retrospective and prospective data – which then had to pivot to virtual patient visits mid-way through the data collection process.
In this webinar experts explore how to develop your marketing application strategy, analyze the benefits and risks associated with your data migration strategy and coordinate with the medical writing team so that all the information needed to write and complete the modules of the submission is provided with adequate time for review and quality control.
Nothing is standard about the study design, study conduct or the regulatory process in cell and gene therapy trials. Every cell and gene therapy is different due to the specific characteristics of each product, with a complicated regulatory approval process and unique therapeutic challenges. In this webinar, participants will learn an end-to-end approach to bringing a cell and gene therapy to market.