Regulatory Webinars

  1. Managing A Continually Evolving Disclosure Landscape 2/20/2024

    Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.

  2. Exploring The Interactions Between Validation, Technology Transfer 1/24/2024

    Listen as Gerardo Gomez delves into the intricate relationship between validation and technology transfer, taking into account the perspectives and standards set by regulators.

  3. Navigating The Unique Attributes Of Psychedelic Drug Development 1/22/2024

    Join our panel of experts for an in-depth review of the FDA's guidance on psychedelic drug development, exploring necessary methodological adaptations for safety, pharmacology, and efficacy.

  4. ICH E6(R3): Practical Steps For Implementation 12/14/2023

    Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.

  5. Early Access Programs: What They Are And How To Plan For Them 12/5/2023

    Explore how early access programs are tailored to individual sufferers of rare, ultra-rare, or life-threatening conditions, as well as cohort programs, which target groups of patients afflicted with the same disease.

  6. EU CTR: An Introduction To European Clinical Trial Transparency 12/4/2023

    Listen in as regulatory expert Pierre-Frederic Omnes takes viewers through an overview of the European Clinical Trial Regulation (EU CTR) and its impact on clinical trials.

  7. Navigating The Process Of Technology Transfer 11/14/2023

    Olena Chervonenko, Associate Director Quality Management and Compliance at PharmaLex, provides deeper insights into technology transfer and essential factors for achieving success.

  8. Meeting Diversity Goals Through Smart Trial Design Strategies 11/8/2023

    Delve into strategies for effectively monitoring and reporting progress toward achieving patient diversity objectives.

  9. 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.

  10. The Advantages Of Conducting Early Phase Trials In North America 10/24/2023

    In this webinar, Altasciences discuss the similarities and differences of conducting early phase research in North America versus other geographic regions.