Results 221 to 230 of about 7,267,063 (234)

Challenges and opportunities for access to Advanced Therapy Medicinal Products in Brazil

Cytotherapy
The marketing authorization of Advanced Therapy Medicinal Products (ATMPs) in Brazil is recent. The features of these therapies impose specialized regulatory action and are consequently challenging for developers. The goal of this study was to identify the industry's experience in clinical development, marketing authorization and access to ATMPs ...
Camile Giaretta Sachetti, Augusto Barbosa, Antonio Carlos Campos de Carvalho, Denizar Vianna Araujo, Everton Nunes da Silva   +4 more
openaire   +2 more sources

[Clinical trials with advanced therapy medicinal products].

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 2010
For advanced therapies, the same basic principles for assessment apply as for any other biotechnological medicinal product. Nevertheless, the extent of data for quality, safety, and efficacy can be highly specific. Until recently, advanced therapies were not uniformly regulated across Europe, e.g., tissue engineered products were regulated either as ...
M, Schüssler-Lenz, C K, Schneider
openaire   +1 more source

Advanced therapy medicinal products: Gene therapy

Pharmaceuticals Policy and Law, 2015
Ayala, Antonio, Muñoz, Mario, Argüelles, Sandro, Zurita, Francisco, Cano, Mercedes   +4 more
openaire   +1 more source

Advanced Therapy Medicinal Products

2021
openaire   +1 more source

The advanced therapies medicinal products - A Belgian perspective

2008
Cf ...
Martens, Marc, Carbonelle, Nicolas
openaire   +1 more source

[European pharmacovigilance of advanced therapy medicinal products].

Annales pharmaceutiques francaises
Advanced therapy medicinal products (ATMPs) are playing an increasingly important role in therapeutics, and sometimes represent the only hope of improving or even curing some pathologies. Because of their biological origin, composition, mode of action, and their frequent technical complexity, ATMPs are potentially generating new risks.
Nadine, Petitpain, Viktoryia, Prontskus, Mélanie, Gauthier, Lena, Loutterbach, Cécile, Pochon, Jean Hugues, Dalle, Danièle, Bensoussan   +6 more
openaire   +1 more source

Europe’s Advanced Therapy Medicinal Products: chances and challenges

Expert Review of Medical Devices, 2009
Heike, Mertsching, Thorsten, Walles
openaire   +2 more sources

2023 PDA Advanced Therapy Medicinal Products Conference

PDA Journal of Pharmaceutical Science and Technology, 2023
openaire   +2 more sources

EVENT TRACKING FOR ADVANCED THERAPY MEDICINAL PRODUCTS

2022
openaire   +4 more sources

Hospital Exemption for Advanced Therapy Medicinal Products in Spain

Human Gene Therapy
Marcos Timón, Sol Ruiz
openaire   +2 more sources