VeriStat Webinars

1. Orphan Drug Designation: The Considerations, The Rewards, And How They Differ Between The US And Europe 11/11/2022

   The National Institutes of Health (NIH) estimates that 1 in 10 Americans are affected by a rare disease or condition. Find out the challenges and regulatory framework for rare disease in this webinar.

2. Pivoting To Remote Visits Mid-Study To Keep A Rare Disease Trial On-Track 8/22/2022

   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. 

3. Different Approaches For Preparing A Marketing Application 5/4/2021

   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.

4. Are You Ready To Begin Planning Your IND Submission? 5/4/2021

   Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a new drug or biologic product. But, are you ready? In this webinar, experts explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND.

5. Roadmap To Market For Cell And Gene Therapies Webinar 1/15/2021

   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.