REGULATIONS & COMPLIANCE
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.
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.
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...
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...
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.
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.
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...
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.
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.
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 ...
Overcoming Financial Toxicity In Oncology Clinical Trials
Review the historical struggles of oncology research due to financial toxicity, which industry initiatives are breaking barriers, and ongoing D.C. advocacy for lower patient stipend taxes.
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.
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.
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).
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.
TMF SUMMER SHORTS: House Of The Inspector
Discover key steps you can take to not just survive an inspection, but take the TMF Throne.
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.
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.
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.
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.
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.
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.
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.
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>
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.
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.
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...
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.
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.