Regulatory Webinars

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Balancing Data, Technology, And Strategy In Clinical Research 6/11/2024

    Here, viewers will learn about best practices for developing an effective data collection strategy and selecting technology solutions that align with research needs.