REGULATIONS & COMPLIANCE
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.
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.
The Journey From File To Trial: Automating Regulatory To TMF
In this webinar, we explore the value of automation between the Trial Master File (TMF) and Regulatory solutions. This connection can bridge the gap from the clinical trial to the regulatory filing, ensuring consistency of information while reducing duplicated data ...
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 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See how sponsors are employing technology to replace outdated, paper-based patient communications about trial results.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 ...
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.
Risk-Based Quality Review: Inside Out
Walk through how to manage and resolve the often conflicting internal and external directives to find the right path for you.
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.
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Exploring The FDA's Draft Guidance On Psychedelic Drug Research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.
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.
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...
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.
Tackling The EU CTR Compliance Challenge
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?
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.
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.
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.
TMF SUMMER SHORTS: House Of The Inspector
Discover key steps you can take to not just survive an inspection, but take the TMF Throne.
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.
US And EU Regulatory Expectations For Combination Products
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.
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.
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...
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.
Beyond First Impressions: CTIS Lessons Learned In First 3 Months
Now that the EU’s Clinical Trials Information System (CTIS) is up and running, disclosure and transparency experts from Sarepta, Boehringer Ingelheim, Bayer and Merck KgaA discuss the ins and outs of registering clinical trials and submitting study information to th...
PLS Perspectives: Sponsor, Author & Regulatory Viewpoints
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 ...
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 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...
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.
The Advantages Of Conducting Early Phase Trials In North America
In this webinar, Altasciences discuss the similarities and differences of conducting early phase research in North America versus other geographic regions.