Global laws, regulations, guidelines, and guidances govern prescription biopharmaceutical and device product development, approval, and maintenance. DIA provides a unique forum that encourages open dialogue among regulators and other thought leaders to discuss challenges around global regulations and their impact on development strategies, global harmonization, and convergence to improve the practice of regulatory affairs.
Regulatory Environment and Approvals in Cell and Gene Therapy Products Between Japan, the USA, and the EU
This study aimed to demonstrate the differences in the way cell and gene therapy (CGT) products have been developed and reviewed for approval in Japan, the USA, and the EU by comparing regulations and successfully launched products in each region, and to examine the background to such differences.
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Submit an abstract for an existing or future event on any topic that advances the pharmaceutical, biotechnology, medical device, and related fields.
Content Highlights
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Enabling Platform Trials with Master Protocols: How EU-PEARL and TransCelerate BioPharma Created a Global Template
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How Did We Get Here? A History of eCTD and Prospects for eCTD 4.0
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The African Medicines Agency: Building a New Gold Standard in Regulatory Excellence: Insights from DIA Europe 2024
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Regulatory Affairs: The IND, NDA, and Post-Marketing On-Demand Training
Complete this On-Demand Training Course to learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.
US Regulatory and Compliance Considerations Online Course
Increase your understanding of regulations and guidance around the dissemination of information about drug products in the US.