Regulatory Webinars

  1. Tackling Performance Requirements In The World Of IVDR 4/5/2023

    In this podcast episode focused on navigating the heightened performance requirements of the IVDR, Keely So provides valuable insights and strategies to effectively tackle these regulatory challenges.

  2. 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.

  3. The Influence Of MDR's Article 117 In The Marketing Of Combination Products 2/21/2023

    While improving patient safety measures, learn how MDR’s Article 117 is causing implications for manufacturers, as they must fulfill a significant set of additional requirements.

  4. Navigating Early Phase CNS-Active Drug Development 2/14/2023

    Early development of CNS-active drugs requires in-depth clinical expertise. Altasciences’ Dr. Beatrice Setnik, Chief Scientific Officer, examines the strategies to ensure early comprehensive data collection to fulfill regulatory requirements and aid in evaluating the risk/benefit profile.

  5. 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.

  6. 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.

  7. Issue 14 — CNS Active Drugs: Complex Considerations 2/2/2023

    In this issue, review complex considerations for the development of central nervous system-active drugs, including the Controlled Substances Act, preclinical and clinical data requirements, and additional assessments your program may need.

  8. Issue 9: Cardiac Safety Assessment In Clinical Trials 2/2/2023

    Listen to this discussion on global regulations, design, and timing of QT assessment, including a case study from a first-in-human clinical trial.

  9. Issue 6: Hybrid Medicines And 505(b)(2) NDA Approval Pathways 2/2/2023

    Learn why hybrid medicines require re-approval for market authorization, partly based on data from the original reference medicine, and partly on data from new clinical trials on the modified version.

  10. Issue 5: The Global Challenge Of Metabolic Disorders 2/2/2023

    Metabolic disorders can take many forms, with obesity and diabetes being the most common. Once considered a high-income country problem, learn why obesity is now on the rise even in low- and middle-income countries.