Regulatory Webinars

  1. Overcoming The Challenges Of Manufacturing And Clinical Trials 8/20/2024

    <p>Learn how CROs and CDMOs work in tandem to successfully address operational and regulatory challenges for pharmaceutical and biotech companies, and how this can determine study success or failure.</p>

  2. CMC Roadmap: Considerations For Small Molecules, Recombinant Proteins 8/16/2024

    This presentation guides viewers through essential questions and real-world scenarios, helping to craft a successful Regulatory CMC roadmap throughout the clinical development lifecycle.

  3. What To Expect After An FDA 483 7/25/2024

    Vincent Cafiso, a former FDA investigator, talks about what to do after an FDA inspection of your clinical trial site. “Don’t expect you’re not going to get a 483,” he says. But how you react to that 483 can deeply affect your company —possibly — for years to come.

  4. ICH E9(R1) Addendum On Estimands And Sensitivity Analysis 7/23/2024

    Discover how the new framework will improve the way of designing and planning clinical trials and performing primary analyses and sensitivity analyses.

  5. TrialScope Intelligence 7/16/2024

    This easy-to-use platform reduces the risk of clinical trial disclosure noncompliance by tracking global disclosure regulations for you. Browse comprehensive regulatory authority and trial registry requirements.

  6. Ensuring Effective PV Regulatory Intelligence With FSP Partnerships 6/25/2024

    Gain insights into what to look for in an FSP PV partner who can provide solid regulatory expertise and effective safety reporting across pharmaceutical, biotech, and medical device development.

  7. Moving In Unison: Proprietary Scheduling Platform 6/18/2024

    Join us for an exclusive discussion that uncovers the science behind our efficient management of key sponsor deliverables and critical milestones, driving our projects to success.

  8. 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.

  9. How To Take Advantage Of Early Access Programs For The EU 6/12/2024

    Learn how to leverage Early Access Programs (EAPs) in the EU to expedite market entry for innovative life science products. Gain insights into running successful EAPs, including crucial steps for France.

  10. 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.