Scendea’s Post

Final panel discussion for CASSS Strategy Forum North America 2024. Robust dialogue on the topic of regulatory submissions for bioconjugates (including post-approval changes). Great hearing from representatives of the FDA and Health Canada | Santé Canada #knowledgesharing #submissions #postapprovalchange #cmcna2024 CASSS – Sharing Science Solutions

In the second session of the GetReal Institute Conference 2024, an expert panel, moderated by Álmath Spooner (AbbVie), explored the integration of #RWE in #regulatory decision-making. Panelists included Patrice Verpillat (European Medicines Agency), Donna Rivera (FDA), Alison Cave (Medicines and Healthcare products Regulatory Agency) and Katrien Oude Rengerink (College ter Beoordeling van Geneesmiddelen–Medicines Evaluation Board [CBG-MEB]). Read at The Evidence Base® #rwd #realworldevidence #realworlddata #regulation #regulatoryaffairs #healthdata #healthpolicy

#FoodForThought The FDA released draft guidance for Data Monitoring Committees (DMCs). Key points: * More oversight for trials with high-risk or no full consent. * Focus on DMC independence to avoid bias. * Guidance on DMC responsibilities for data review & trial modifications. Important for clinical trial sponsors & researchers. #FDA #clinicaltrials #clinicalresearch

Did you know the FDA recently updated informed consent requirements for minimal risk clinical trials? Click the link to find out how these changes will help streamline research. #ParticipantSafety #ClinicalResearch

Did you know the FDA recently updated informed consent requirements for minimal risk clinical trials? Click the link to find out how these changes will help streamline research. #ParticipantSafety #ClinicalResearch

Did you know the FDA recently updated informed consent requirements for minimal risk clinical trials? Click the link to find out how these changes will help streamline research. #ParticipantSafety #ClinicalResearch

Regulator town halls at #DIA2024 highlighted a global commitment to harmonized regulations, innovation-driven healthcare strategies, and patient-centric policies for advancing public health. Key global priorities include: Modernization and Innovation:  Evolving regulatory frameworks to embrace technological advances and support innovation in drug development with a focus on agility and transparency. Data Integrity and Transparency:  Emphasis on enhancing data reliability and transparency in clinical trials and regulatory processes, and standardizing data elements. Support for Decentralized Clinical Trials (DCTs): Increasing support for DCTs to improve patient access and ensure data quality while aligning with international standards. International Collaboration and Harmonization:  Promoting collaboration among regulatory authorities to streamline global drug development through mutual recognition of inspections and harmonized regulatory requirements. Patient-Centric Approaches:  Integrating patient perspectives into regulatory decisions to ensure safety and facilitate access to innovative medicines, emphasizing patient-reported outcomes. Regulatory Flexibility in Response to Challenges:  Adapting regulatory processes to the rapid development of advanced therapies and medical products, especially for unmet medical needs and global challenges. Enhanced Regulatory Transparency: Increasing public accessibility to regulatory information, engaging stakeholders in decision-making, and ensuring accountability. https://lnkd.in/gD-63iFw

Do not miss out this opportunity to explore an array of reliance tools in this webinar on "Regulatory Reliance Tools Unveiled: A Practical Guide by EMA" and how they can enhance efficiency and collaboration across regulatory authorities.  #EuropeanMedicinesAgency #EMA #RegulatoryReliance #WHO #GlobalHealthcare Secure your spot by register here: https://lnkd.in/dsZxamt4 

Discover the latest EMA guidance now!