Regulations & Compliance STREAM

  1. Preparing For 2022 1/19/2022

    2022 will be an important year for drug development. There are many questions around changes that came into play during the pandemic. A panel of experts look back over the year and into the future to help you prepare for the coming year.

  2. Is EU CTR Driving Tighter Clinical & Regulatory Integration? 3/31/2022

    The new Clinical Trials Regulation (EU) 536/2014 has raised critical questions about business process and data interactions between Clinical and Regulatory in biopharmaceutical companies. Did you know that as of 6 March 2022, there were more than 200 draft applications in CTIS?

  3. 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.

  4. An Overview Of Health Canada's CTA Process 10/24/2023

    Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.

  5. psiXchange: Intelligent, Automated Safety Reporting 3/25/2024

    Say goodbye to manual burdens and embrace efficiency by fully automating your safety reporting. This will significantly cut down on effort and costs, all while enhancing compliance standards.

  6. Addressing Opportunities And Challenges In Digital Health Data 10/22/2024

    Experts from diverse industry sectors unpack key points from the FDA’s final guidance on Digital Health Technologies (DHT) for remote data collection in clinical investigations.

  7. Strategies For Research Institutions In An Evolving Era Of Oncology 11/11/2024

    As biomarker-directed therapies drive advancements in the oncology space, experts are reviewing cutting-edge trends and strategies that help institutions address ethical and regulatory challenges.

  8. Achieving Regulatory Compliance With A Unified Immunogenicity Strategy 5/10/2025

    This presentation equips viewers with the knowledge and tools needed to navigate the intricacies of designing immunogenicity assays that comply with both European IVDR and US FDA regulations.

  9. 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.

  10. Plain Language Summaries Becoming A Mandate Worldwide 6/13/2024

    A growing number of countries are requiring clinical trial protocol and results disclosures to be written in plain language, influencing how these documents are authored.