Regulations & Compliance STREAM

  1. Accelerate Time To Target Endpoint In Cardiometabolic Studies Using Patient-Centered Technology Solutions 6/14/2022

    In this webinar, industry experts share their perspectives on how to address drug development challenges within cardiometabolic clinical studies and provide input on the impact of new regulatory guidance such as the DEPICT Act.

  2. 3 FDA Approvals In 2025 That Shift The Landscape For 2026 1/20/2026

    In this presentation, Precision’s Chief Medical Officer and former FDA Director, Division of Oncology 2, Harpreet Singh, MD breaks down 3 FDA approvals from last year that are impacting 2026.

  3. 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.

  4. The Many Facets Of Early Phase Evaluation Of Psychedelics In Psychiatry 2/3/2023

    Altasciences and Sygnature Discovery discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs.

  5. 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.

  6. Reporting To ClinicalTrials.gov: Reflections And Challenges 11/7/2019

    Who can reflect better on this topic than Dr. Deborah Zarin, former director of ClinicalTrials.gov? Dr. Zarin, now with the MRCT Center, shared her experiences and advice at the recent EXTRA: TrialScope Transparency Experience.

  7. 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.

  8. Taking A Risk-Based Approach To An Inspection-Ready Audit Trail 2/10/2021

    Regulatory agencies agree that a risk-based approach is the best way to ensure quality in clinical trials. But knowing how to implement such a process can be daunting. In this session, we will explore how to implement RBM to ensure your TMF Audit Trail is ready for inspection.

  9. 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.

  10. Navigating Special Regulatory Pathways For Advanced Therapy Development Success 6/12/2025

    Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.