Results 41 to 50 of about 7,267,063 (234)

European Regulatory Tools for Advanced Therapy Medicinal Products [PDF]

open access: yesTransfusion Medicine and Hemotherapy, 2013
Increasing scientific knowledge and technical innovations in the areas of cell biology, biotechnology and medicine resulted in the development of promising therapeutic approaches for the prevention and treatment of human diseases. Advanced therapy medicinal products (ATMPs) reflect a complex and innovative class of bio-pharmaceuticals as these products
Egbert, Flory, Jens, Reinhardt
openaire   +2 more sources

Translational research on advanced therapies

open access: yesAnnali dell'Istituto Superiore di Sanità, 2011
Fostering translational research of advanced therapies has become a major priority of both scientific community and national governments. Advanced therapy medicinal products (ATMP) are a new medicinal product category comprising gene therapy and cell ...
Filippo Belardelli   +5 more
doaj   +1 more source

Dissolvable Face Mask with Liposomal Licorice Extract and Kojic Acid: An Innovative Approach for Skin Brightening

open access: yesCosmetics
This study developed a biodegradable dissolvable face mask incorporating liposomal kojic acid (KA) and licochalcone A from licorice extract (LE) to enhance skin delivery and performance. Liposomes were prepared by thin-film hydration method.
Theerada Taesotikul   +6 more
doaj   +1 more source

Recent Progress in European Advanced Therapy Medicinal Products and Beyond

open access: yesFrontiers in Bioengineering and Biotechnology, 2018
Cell- and gene-based therapies form one of the pillars of regenerative medicine. They have the potential to transform quality of life and improve the health status of patients with genetic and cellular defects, including genetic diseases ...
Tracy T. L. Yu   +6 more
doaj   +1 more source

A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations

open access: yesFrontiers in Medicine, 2022
Cell and Gene Therapy Products (CGT), regulated as Advanced Therapy Medicinal Products (ATMP) in the European Union (EU), represent a novel and varied group of biotherapeutics developed to treat specific conditions for which there are limited or no ...
Laura I. Salazar-Fontana   +2 more
doaj   +1 more source

Advanced Therapy Medicinal Products as Potential Therapeutic Strategy against COVID-19 and Immune-Related Disorders. [PDF]

open access: yesInt J Mol Sci
Advanced Therapy Medicinal Products (ATMPs) comprise a heterogenous class of innovative medicinal products, which further require extensive preclinical and clinical assessments before their broader use in the general population [...
Mallis P   +2 more
europepmc   +2 more sources

Herbal products: Marketing strategies and legislation [PDF]

open access: yes, 2009
Marketing of herbal products in the European Union (EU) has been regulated under national legislation for years, leading to differences in legal status of these herbal products.
Hooyenga, P.A.   +2 more
core   +1 more source

Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials [PDF]

open access: yesJournal of Market Access & Health Policy, 2016
Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in ...
Hanna, Eve   +3 more
openaire   +2 more sources

Advanced Therapy Medicinal Products (ATMP)and exemptions to the Regulation 1394/2007: how confident can we be? An exploratory analysis.

open access: yesFrontiers in Pharmacology, 2012
The market authorisation procedure for medicinal products for human use is relying on their demonstrated efficacy, safety and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the
Philippe eVan Wilder
doaj   +1 more source

The regulation of advanced therapy medicinal products in europe and the role of academia [PDF]

open access: yesCytotherapy, 2013
Advanced therapy medicinal products (ATMP) are gene therapy, somatic cell therapy or tissue-engineered products regulated under (EC) No. 1394/2007 to ensure their free movement within the European Union while guaranteeing the highest level of health protection for patients.
Pearce KF   +11 more
openaire   +3 more sources

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