REGULATIONS & COMPLIANCE
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.
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.
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.
Managing A Continually Evolving Disclosure Landscape
Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.
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...
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...
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.
Achieving Regulatory Compliance With A Unified Immunogenicity Strategy
This presentation equips viewers with the knowledge and tools needed to navigate the intricacies of designing immunogenicity assays that comply with both European IVDR and US FDA regulations.
What Should You Ask The FDA About AI
Understanding what some of the common questions the FDA gets about AI may help you as you plan to interact with the agency.
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.
The FDA's View Of AI In Clinical Trials Is Limited
Tala Fakhouri explains that there could be so many more applications of AI in clinical development than what the FDA sees in regulatory submissions.
AI In Action: Transforming Clinical Trials
Tala Fakhouri, associate director for data science and ai policy at the FDA, along with industry consultant Elena “Ella” Sinclair of FlexPoint Bio, talk about common applications of AI in clinical development and the new AI-focused regulatory Guidance from the...
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.
An Overview Of Health Canada's CTA Process
Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.
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...
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.
Moving In Unison: Proprietary Scheduling Platform
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.
Strategies For Research Institutions In An Evolving Era Of Oncology
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.
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.
Navigating Early Phase CNS-Active Drug Development
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 th...
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.
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.
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.
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.
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.
Human Abuse Potential: Pharmacy Considerations
Master the complexities of controlled substance handling, over-encapsulation, and dosing strategies to ensure the data integrity and regulatory compliance of abuse potential assessments.
psiXchange: Intelligent, Automated Safety Reporting
Say goodbye to manual burdens and embrace efficiency by fully automating your safety reporting. This will significantly cut down on effort and costs, all while enhancing compliance standards.
Reporting To ClinicalTrials.gov: Reflections And Challenges
Who can reflect better on this topic than Dr. Deborah Zarin, former director of ClinicalTrials.gov? Dr. Zarin, now with the MRCT Center, shared her experiences and advice at the recent EXTRA: TrialScope Transparency Experience.