REGULATIONS & COMPLIANCE
Accelerate Time To Target Endpoint In Cardiometabolic Studies Using Patient-Centered Technology Solutions
In this webinar, industry experts share their perspectives on how to address drug development challenges within cardiometabolic clinical studies and provide input on the impact of new regulatory guidance such as the DEPICT Act.
See How You Can Start Your Early Phase Program 6-9 Weeks Earlier In Canada
Vice President of Business Development Lisa Sanford explains whether you need an IND before starting your first-in-human trial in Canada.
Driving Product Launch Success In Europe
Explore key steps for preparing your medicinal product for the European market, including insights on challenges, timelines, and a success story.
3 FDA Approvals In 2025 That Shift The Landscape For 2026
In this presentation, Precision’s Chief Medical Officer and former FDA Director, Division of Oncology 2, Harpreet Singh, MD breaks down 3 FDA approvals from last year that are impacting 2026.
Addressing Opportunities And Challenges In Digital Health Data
Experts from diverse industry sectors unpack key points from the FDA’s final guidance on Digital Health Technologies (DHT) for remote data collection in clinical investigations.
Is EU CTR Driving Tighter Clinical & Regulatory Integration?
The new Clinical Trials Regulation (EU) 536/2014 has raised critical questions about business process and data interactions between Clinical and Regulatory in biopharmaceutical companies. Did you know that as of 6 March 2022, there were more than 200 draft applications in...
Unlock The Secrets Of Managing CTR In A Complex Development Landscape
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.
Quality Checks Vs. Quality Review
Watch this presentation where speakers share how teams can improve inspection readiness and reduce potential regulatory risks that could negatively impact operational activities.
How Standardized Terminology Can Accelerate Global Regulatory Performance
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.
Plain Language Summaries Becoming A Mandate Worldwide
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.
How ICH Oversight And AI Are Shaping The Future Of Clinical Trials
Explore how the new ICH E6 (R3) revisions are reshaping clinical trial oversight and examine how AI-driven tools like the Clinical Decision Suite can help sponsors enhance trial efficiency.
Evaluating Abuse Potential Of CNS-Active Drugs For EU And US Submissions
Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.
Improving Safety Reporting Speed And Accuracy With Automation And Embedded Intelligence
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.
What Is 'Fit For Use' In AI Models?
The data that you use to train AI models has to be “fit for use” according to the FDA. Tala Fakhouri explains what metrics the FDA uses to make this determination.
TMF SUMMER SHORTS: House Of The Inspector
Discover key steps you can take to not just survive an inspection, but take the TMF Throne.
The Big Picture: Impact Of EU Disclosure On Small & Mid-Size Sponsors
With the new EU clinical trial registry portal expected to launch next year, it’s imperative that sponsors – particularly small and mid-size organizations – understand the complexities of EU disclosure. Thomas Wicks, an expert in clinical trial disclosur...
The Benefits Of Conducting A Clinical Trial In Canada
Watch this video in which Altasciences’ regulatory experts share key insights on Health Canada’s Clinical Trial Application (CTA) regulatory submission process.
An Innovative Approach To Trial Results Summaries
See how sponsors are employing technology to replace outdated, paper-based patient communications about trial results. This innovative approach enables clinical trial sponsors to meet their ethical obligations to trial participants while simultaneously increasing patient ...
Navigating Special Regulatory Pathways For Advanced Therapy Development Success
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.
Think Canada: The Team Behind Your Clinical Trials
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.
The Many Facets Of Early Phase Evaluation Of Psychedelics In Psychiatry
Altasciences and Sygnature Discovery discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs.
How To Take Advantage Of Early Access Programs For The EU
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.
Navigating The Unique Attributes Of Psychedelic Drug Development
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.
TrialScope Intelligence
This easy-to-use platform reduces the risk of clinical trial disclosure noncompliance by tracking global disclosure regulations for you. Browse comprehensive regulatory authority and trial registry requirements.
Taking A Risk-Based Approach To An Inspection-Ready Audit Trail
Regulatory agencies agree that a risk-based approach is the best way to ensure quality in clinical trials. But knowing how to implement such a process can be daunting. In this session, we will explore how to implement RBM to ensure your TMF Audit Trail is ready for inspec...
Preparing For 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.
Overcoming The Challenges Of Manufacturing And Clinical Trials
<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>
Illuminating IHC: Right-Sizing Your Validation And Regulatory Strategy
In this presentation, expert speakers provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC).
Exploring The Principles Integral To Rare Disease Drug Development
This on-demand webinar offers valuable insights into successful rare disease drug development, including study design, regulatory engagement, and market access strategy.
Exploring The FDA's Draft Guidance On Psychedelic Drug Research
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.