Regulations & Compliance STREAM
-
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.
-
Moving In Unison: Proprietary Scheduling Platform
6/18/2024
Join us for an exclusive discussion that uncovers the science behind our efficient management of key sponsor deliverables and critical milestones, driving our projects to success.
-
US And EU Regulatory Expectations For Combination Products
6/11/2024
Explore the regulatory nuances in the US and EU for combination products in this on-demand webinar. Key topics include differing regulatory requirements, the influence of new guidelines, and more.
-
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.
-
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.
-
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>
-
Exploring The FDA's Draft Guidance On Psychedelic Drug Research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.
-
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.
-
Improving Safety Reporting Speed And Accuracy With Automation And Embedded Intelligence
3/15/2024
Watch this exploration of real-world case studies of companies utilizing intelligent process automation and embedded, regularly updated safety reporting regulatory intelligence of psiXchange software.
-
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.