Manufacturers of Human Tissue Engineered Products (HTEPs) need to develop a very strong position paper to put an end to regulators treating so many of these products as cell therapy products and compelling manufacturers to comply with the medicinal products Directive, 2003/63/EC.
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2024 is here and will be a crucial year for your clinical trials in the European Union (EU) and European…
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When submitting and IND for CGT product/therapy, it’s crucial to confirm that the viral vector in use is appropriate, especially…
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In the ever-evolving landscape of pharmaceuticals/biopharmaceuticals, manufacturing changes play a pivotal role in ensuring the quality and effectiveness of medicinal…
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ATMPs (Advanced Therapeutic Medicinal Products) in Europe, or CGTs (Cell and Gene Therapies) as they are known in the US,…
