24_10_STREAM_SiteHeader_CL

REGULATIONS & COMPLIANCE

55:25 GettyImages-1276620416_mushrooms
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.

59:51 Phlex
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 ...

37:39 TrialScope
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See how sponsors are employing technology to replace outdated, paper-based patient communications about trial results.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 ...

54:07 The Big Picture: Impact Of EU Disclosure On Small & Mid-Size Sponsors
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...

49:08 Navigating Special Regulatory Pathways For Advanced Therapy Development Success
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.

1:00:17 Strategies For Research Institutions In An Evolving Era Of Oncology
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.

59:19 Plain Language Summaries Becoming A Mandate Worldwide
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.

58:39 actigraph_fda
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.

40:32 altasciences canada benefits webinar thumb
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.

59:11 human-heart-cardiac
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.

54:33 How To Take Advantage Of Early Access Programs For The EU
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.

32:01 phlex quality web thumb
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.

52:39 Untitled-1
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.

12:56 altasciences cns web thumb
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...

33:44 Driving Product Launch Success In Europe
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.

33:13 Tackling The EU CTR Compliance Challenge
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?

53:44 GettyImages-164198023-cell-line-development
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.

3:15 Altasciences scheduling system
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.

36:29 Improving Safety Reporting Speed And Accuracy
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.

5:38 3 FDA Approvals In 2025 That Shift The Landscape For 2026
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.

3:46 think canada thumb
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.

23:32 medical data regulatory GettyImages-970438352
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...

15:56 Trialscope
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.

53:32 Exploring The Principles Integral To Rare Disease Drug Development
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.

59:35 GettyImages-1295039463-dna-research-computer-lab
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...

1:01:12 Phlex2
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...

1:00:16 PFM gene therapy assay
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.

1:02:22 Illuminating Immunohistochemistry - feature image
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).

1:03:48 altasciences hop across the pond web thumb
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.

1:00:38 phlexglobal webinar 1
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.