Regulations & Compliance STREAM

31. Overcoming The Challenges Of Manufacturing And Clinical Trials 8/20/2024

    <p>Learn how CROs and CDMOs work in tandem to successfully address operational and regulatory challenges for pharmaceutical and biotech companies, and how this can determine study success or failure.</p>

32. The Journey From File To Trial: Automating Regulatory To TMF 2/9/2021

    In this webinar, we explore the value of automation between the Trial Master File (TMF) and Regulatory solutions.  This connection can bridge the gap from the clinical trial to the regulatory filing, ensuring consistency of information while reducing duplicated data entry.

33. 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.

34. 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.

35. Quality Checks Vs. Quality Review 8/22/2023

    Watch this presentation where speakers share how teams can improve inspection readiness and reduce potential regulatory risks that could negatively impact operational activities.

36. 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.

37. 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.

38. TMF SUMMER SHORTS: House Of The Inspector 8/29/2024

    Discover key steps you can take to not just survive an inspection, but take the TMF Throne.

39. The Benefits Of Conducting A Clinical Trial In Canada 9/19/2023

    Watch this video in which Altasciences’ regulatory experts share key insights on Health Canada’s Clinical Trial Application (CTA) regulatory submission process.

40. How Standardized Terminology Can Accelerate Global Regulatory Performance 6/24/2022

    Watch this panel of regulatory experts taking part in an interactive roundtable examining the benefits of establishing standard terminology and its potential to help significantly improve regulatory quality, data accuracy, and efficiency.