Cell and Gene Regulatory
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The Synergistic Role Of Drug Safety In Clinical Trial Operations
4/25/2024
Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.
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Integrating Quality Processes And Documentation After A Merger
4/25/2024
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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5 Areas To Focus Your QRM Strategy - Sterile Drug Products
4/24/2024
Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products
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China’s Rising Role On The Global Stage In The Oncology Market
4/23/2024
The oncology pharma market has largely been dominated by European and U.S. companies. With the ongoing expansion of the Chinese biopharma sector, innovative oncology drugs will emerge from China and compete on the international market.
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Cell & Gene Therapy Testing
4/22/2024
Cell and Gene Therapies hold immense potential for revolutionizing healthcare. However, ensuring the safety and efficacy of these therapies is paramount. Learn how the right partner can empower you to unlock the full potential of your CGT.
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The FDA Modernization Act is Signed Into Law. Now What?
4/22/2024
Scientists worldwide celebrated the signing of the FDA Modernization Act into law. Gain expert insights into what to anticipate regarding using New Approach Methods (NAMs) in novel IND submissions.
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Clinical Research As A Delicate Ecosystem
4/18/2024
Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.
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Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024
4/17/2024
This article outlines key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.
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Tips For Viral Vector Production
4/16/2024
Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
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Stem-Cell Derived Therapies: From Source To Site
4/16/2024
Stem cells are the backbone of many allogeneic, “off-the-shelf” cell therapies. Watch as industry experts discuss questions and considerations regarding stem-cell-derived therapies