VeriStat Webinars

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

    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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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. 

  8. 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.

  9. 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.

  10. 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.