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Advanced Therapy Medicinal Products: An Innovative and Collaborative Approach
Advanced therapy medicinal products (ATMPs) belong to a rapidly developing, state-of-the-art field of science and technology in the EU. Due…
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The Challenges of Potency Assay Development for Cell-based Medicinal Products in Europe
Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature…
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Considerations on Pediatric Investigation Plans (PIP) for Advanced Therapy Medicinal Products
In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company…
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Implementing the new EU Legislation on advanced therapy Medicinal product
An EMA workshop in London gave an important insight into the implementation of the European regulation on Advanced Therapy Medicinal…
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Update on the Implementation of European ATMP Regulation
A July 2009 adoption/publication of a revised Annex I of Directive 2001/83/EC is foreseen. Discussions on how to appropriately assess…
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The Implementation of the European Tissues and Cells Directives in France
The main purpose of the tissues and cells directives has been to define a minimum level of quality and standards…
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Human Tissues: consultants call for end to EU regulatory confusion
Manufacturers of Human Tissue Engineered Products (HTEPs) need to develop a very strong position paper to put an end to…
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Advanced Therapies in the EU speedy adoption or beleaguered by questions
The industry is caught between wanting numerous questions answered in the text and a rapid implementation of new rules to…
