Regulations & Compliance STREAM
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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.
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Strategies For Research Institutions In An Evolving Era Of Oncology
11/11/2024
As biomarker-directed therapies drive advancements in the oncology space, experts are reviewing cutting-edge trends and strategies that help institutions address ethical and regulatory challenges.
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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.
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PLS Perspectives: Sponsor, Author & Regulatory Viewpoints
2/24/2020
In this informative webinar, Jazz Pharmaceuticals will provide tips on launching a PLS program. A medical writer from ClaritiDox will give an overview of PLS best practices. And TrialScope’s chief strategy officer will share – and analyze – results from TrialScope’s recent PLS survey.
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Think Canada: The Team Behind Your Clinical Trials
9/29/2023
Altasciences has a bioanalytical and clinical facility in Canada. In this video, we unveil the advantages of conducting trials in Canada while introducing some of the faces that work behind the scenes on your studies.
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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.
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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.
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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.
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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.
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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.