REGULATIONS & COMPLIANCE
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.
Stay Audit-Ready: Practical Compliance Insights For Research Sites
Gain an auditors insight into common compliance gaps and learn practical ways to strengthen audit readiness in sIRB studies.
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.
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 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.
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 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.
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.
Should Sponsors Provide Source Document Templates?
Here, we debate sponsor-provided source document templates, weighing regulatory guidance, compliance risks, and operational impacts for smarter clinical trial documentation decisions.
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>
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.
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.
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.
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.
Ensure Regulatory Success With Support From Your IRT Partner
In this presentation, you’ll get recommendations to help you stay inspection-ready and learn about the importance of clear roles, audit trails, data integrity, and training.
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.
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.
Accelerating Clinical Data Review With Traceable Workflows
Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.
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.
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 ...
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 ...
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.
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.
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.
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.
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.
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.
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.