REGULATIONS & COMPLIANCE
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.
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.
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.
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.
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...
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.
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.
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.
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.
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.
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?
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.
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>
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.
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.
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.
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.
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...
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.
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 ...
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).
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.
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.
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.
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.
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.