INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• Meeting The Demands Of Liquid Biopsy Development

  Gain insights into strategies for designing and executing extensive validation studies for liquid biopsies intended for cancer screening purposes.

• Rare Diseases: Expected Boom In Development And Approval

  Delve into the details of the FDA's "Operation Warp Speed for Rare Diseases" initiative and what sites should do to prepare.

• 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.

• First Round Of Drugs Up For Medicare Negotiation Gets Soft Landing

  Get an in-depth analysis of big pharma valuations following the CMS' initial roster of 10 drugs for Medicare negotiations under the Inflation Reduction Act, which included some unexpected developments and products nearing the end of their patent exclusivity.

• Navigating The Privacy Tightrope For CTIS

  9/19/2023

  Examine the challenges, potential risks, recommended best practices, and future trends related to anonymizing personal data for CTIS submissions.

• From Chaos To Order In 3 Steps: The Guide To Planning Your TMF Migration

  9/18/2023

  Utilize this guide when navigating the most important part of any TMF migration: project scoping and planning.

• TMF Migrations: Streamlining The Journey To An Inspection-Ready Result

  9/18/2023

  Delve into several techniques designed to safeguard data precision and integrity throughout the TMF migration process, reducing compliance risks and conserving valuable time and effort.

• Preparing For Post-Market Clinical Follow-Up Under EU MDR

  9/15/2023

  Better comprehend the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.

• Regulatory Pathways Supporting Accelerated Drug Approval

  9/15/2023

  Examine the various routes for expediting drug development and approval in member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, as well as in Australia.

REGULATORY MULTIMEDIA

• 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.

• TMF Migrations: Streamlining The Journey To An Inspection-Ready Result

  Delve into several techniques designed to safeguard data precision and integrity throughout the TMF migration process, reducing compliance risks and conserving valuable time and effort.

• Optimizing Data Quality In Oncology Trials

  Get key takeaways from the recent FDA guidance on the use of COA and PROMS in oncology trials and other additional insights surrounding the topic.

• GlobalLearn: Study Team Training

  Feel confident that your study team training practices are comprehensive and aligned with both regulatory and corporate mandates by watching this presentation by Trial Interactive's Product Manager, GlobalLearn, Marc Gracieux.

• How Recent Regulations Are Helping Advance eCOA And ePRO

  Consider new perspectives on 2023-issued guidance by the EMA and FDA, and how the amalgamation of these directives, combined with scientific insights, can empower sponsors and biotech firms.

• EU CTR: Focus On CT Transitions

  Watch as TransPerfect Life Sciences Executive Director Pierre-Frederic Omnes explores topics surrounding trial transitions and answers common questions regarding new European requirements.

• FDA & ex-U.S. Product Approval

  Trial protocol strategies for FDA approval must also meet the needs of global regulators, if a therapy is to be commercialized worldwide. Michael Krams, chief quantitative medicine officer at Exscientia explains how R&D leaders should think about FDA and ex-U.S. product approval.

• Phase 2 Clinical Trials: What to Include (And What To Leave Out)

  How do drug developers make decisions about what to include, and what to leave out, of a Phase 2 clinical trial? Mitchell Katz, SVP, global clinical operations at Kyowa Kirin discusses collecting competitive intelligence and forging relationships with regulators.

• 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.

• Future Trends On European Regulations On Medicines

  Gain insight from regulatory experts regarding unmet medical needs, accessibility and affordability, the competitive and innovative European pharma industry, enhancing resilience, and the EU’s global voice.