VeriStat Webinars

1. Advancing Development Of New Oncology Therapies 4/4/2024

   Learn how the FDA's Project FrontRunner expedites cancer drug approval for early advanced metastatic cancer, emphasizing efficacy and safety in earlier clinical settings.

2. Planning For A Successful Initial IND And Moving Beyond 10/10/2023

   Delve into the key challenges, effective strategies, and important considerations for analytical programs aimed at demonstrating comparability.

3. Future Trends On European Regulations On Medicines 7/20/2023

   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.

4. EU Regulations Impacting Medical Device & Drug Combination Product Developments 7/20/2023

   Gain a better understanding of Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), by watching this presentation by regulatory experts.
5. Single-Arm Studies For Use As A Registrational Study In Oncology 6/26/2023

   Listen in as industry experts discuss single-arm oncology registrational studies, success stories, and lessons learned.

6. Decentralized Trial Solutions For Complex Clinical Trials: Webinar Replay 2/21/2023

   Most complex studies are considered challenging, but not impossible. Learn from a collective of experts on how to create successful decentralized clinical trials.

7. Orphan Drug Designation: Considerations, Rewards, And Differences 11/11/2022

   The National Institutes of Health (NIH) estimates that 1 in 10 Americans are affected by a rare disease or condition. Explore global challenges and regulatory frameworks for rare diseases in this presentation.

8. 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. 

9. 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.

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

    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.