Regulations & Compliance STREAM

  1. Unlock The Secrets Of Managing CTR In A Complex Development Landscape 8/29/2024

    Lost in the CTR maze? Watch this webinar to get your burning questions answered by industry experts. Ask about vendor coordination, CTIS integration, and EU strategies.

  2. Exploring The FDA's Draft Guidance On Psychedelic Drug Research 7/26/2023

    Discover the crucial insights and methodological adaptations needed to effectively assess the safety, pharmacology, and efficacy of innovative psychedelic compounds designed for specific medical applications.

  3. 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.

  4. 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.

  5. How To Take Advantage Of Early Access Programs For The EU 6/12/2024

    Learn how to leverage Early Access Programs (EAPs) in the EU to expedite market entry for innovative life science products. Gain insights into running successful EAPs, including crucial steps for France.

  6. 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.

  7. 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>

  8. Risk-Based Quality Review: Inside Out 8/29/2024

    Walk through how to manage and resolve the often conflicting internal and external directives to find the right path for you.

  9. 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.

  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.