Regulatory Solutions

  1. FDA & ex-U.S. Product Approval 8/2/2023

    Trial protocol strategies for FDA approval must also meet the needs of global regulators, if a therapy is to be commercialized worldwide. Michael Krams, chief quantitative medicine officer at Exscientia explains how R&D leaders should think about FDA and ex-U.S. product approval.

  2. Phase 2 Clinical Trials: What to Include (And What To Leave Out) 8/2/2023

    How do drug developers make decisions about what to include, and what to leave out, of a Phase 2 clinical trial? Mitchell Katz, SVP, global clinical operations at Kyowa Kirin discusses collecting competitive intelligence and forging relationships with regulators.

  3. Frozen Packaging Solutions 6/21/2023

    Delve into how this partner's scalable packaging services for logistics support can achieve higher operational efficiency and lower quality and safety risks.

  4. Drug Accountability And Returns Management 6/8/2023

    See how sponsors are using electronic solutions for Drug Accountability (DA) and experiencing significant increases in efficiency and accuracy that these methods provide.

  5. End-To-End Safety Solutions Designed For Success 6/6/2023

    As one of the world’s largest and most experienced safety and PV organizations, unearth how this provider is bringing extensive expertise and regulatory intelligence to every industry engagement.

  6. Strategic Regulatory Documentation Practice 5/31/2023

    Learn how this highly experienced and fully dedicated team is improving timeline creation complexities and management, resourcing, document interdependencies, and transmission to health authorities.

  7. Scalable Manufacturing Of Sterile Drug Products 3/31/2023

    Discover comprehensive clinical to commercial scale manufacturing services that deliver true life-cycle management for sterile drug products that bring treatments to patients with efficiency and quality.

  8. TrialScope Intelligence Disclosure Regulatory Tracking 3/23/2023

    TrialScope Intelligence provides global coverage, monitoring countries with and without current disclosure requirements and sending alerts for changes in regulations. English translations and expert analysis create additional context and further understanding of regulatory expectations.

  9. See How You Can Start Your Early Phase Program 6-9 Weeks Earlier In Canada 3/23/2023

    Vice President of Business Development Lisa Sanford explains whether you need an IND before starting your first-in-human trial in Canada.

  10. Biorasi Puts You On The Path To Successful Regulatory Approval 2/3/2023

    Every journey needs a guide. Let’s talk about an effective regulatory strategy for your next clinical trial.