Regulations & Compliance STREAM

  1. Exploring The Principles Integral To Rare Disease Drug Development 6/12/2024

    This on-demand webinar offers valuable insights into successful rare disease drug development, including study design, regulatory engagement, and market access strategy.

  2. PLS Perspectives: Sponsor, Author & Regulatory Viewpoints 2/24/2020

    In this informative webinar, Jazz Pharmaceuticals will provide tips on launching a PLS program. A medical writer from ClaritiDox will give an overview of PLS best practices. And TrialScope’s chief strategy officer will share – and analyze – results from TrialScope’s recent PLS survey.

  3. The Benefits Of Conducting A Clinical Trial In Canada 9/19/2023

    Watch this video in which Altasciences’ regulatory experts share key insights on Health Canada’s Clinical Trial Application (CTA) regulatory submission process.

  4. Beyond First Impressions: CTIS Lessons Learned In First 3 Months 5/19/2022

    Now that the EU’s Clinical Trials Information System (CTIS) is up and running, disclosure and transparency experts from Sarepta, Boehringer Ingelheim, Bayer and Merck KgaA discuss the ins and outs of registering clinical trials and submitting study information to the portal.

  5. TMF SUMMER SHORTS: House Of The Inspector 8/29/2024

    Discover key steps you can take to not just survive an inspection, but take the TMF Throne.

  6. Driving Product Launch Success In Europe 10/21/2024

    Explore key steps for preparing your medicinal product for the European market, including insights on challenges, timelines, and a success story.

  7. US And EU Regulatory Expectations For Combination Products 6/11/2024

    Explore the regulatory nuances in the US and EU for combination products in this on-demand webinar. Key topics include differing regulatory requirements, the influence of new guidelines, and more.

  8. The Many Facets Of Early Phase Evaluation Of Psychedelics In Psychiatry 2/3/2023

    Altasciences and Sygnature Discovery discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs.

  9. Overcoming Financial Toxicity In Oncology Clinical Trials 10/12/2023

    Review the historical struggles of oncology research due to financial toxicity, which industry initiatives are breaking barriers, and ongoing D.C. advocacy for lower patient stipend taxes.

  10. Evaluating Abuse Potential Of CNS-Active Drugs For EU And US Submissions 1/30/2023

    Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.