Regulations & Compliance STREAM
-
Managing A Continually Evolving Disclosure Landscape
2/20/2024
Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.
-
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.
-
Tackling The EU CTR Compliance Challenge
10/4/2018
Maintaining disclosure compliance is tricky enough with ClinicalTrials.gov, but when it comes to EU CTR compliance, the complexity rises to a whole new level. As a sponsor, do you find your organization “guilty” of these common errors?
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.