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CORDIS - Wyniki badań wspieranych przez UE
CORDIS

Real World Handling of Protein Drugs - Exploration, Evaluation and Education

CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.

Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .

Rezultaty

First version of data management plan. (odnośnik otworzy się w nowym oknie)

First version of data management planDescribes kind of data generated throughout the project their storage handling and securityThe consortium must address the following data protection issues in the Data Management Plan especially sections 4 Data security and 5 Ethics1 The consortium members must confirm that contact details of the Data Protection Officer DPO are made available to all data subjects involved in the research For the members of the consortium not required to appoint a DPO under the General Data Protection Regulation a detailed data protection policy for the project must be elaborated and kept on file It must be provided to IMI JU upon request2 The concerned consortium members must check and confirm to IMI JU if special derogations pertaining to the rights of data subjects or the processing of personal data have been established under the national legislation of the country where the research takes place and provide a declaration of compliance with respective national legal frameworks3 Details of the observationtracking activities such as shadowing of healthcare personnel and tracking patients with the electronic tags attached to drug containers must be provided The applicant must explain if these activities will involve personal data collectionprocessing 4 A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjectsresearch participants must be provided5 Detailed information on the specific data protection informed consent procedures in regard to data processing must be provided prior to the start of the research activity raising ethics issue in case this is not addressed in the informed consent procedures for human participants6 A description of the anonymisationpseudonymisation techniques that will implemented must be provided7 In case personal data are transferred from the EU to a nonEU country or international organisation confirmation that such transfers are in accordance with Chapter V of the General Data Protection Regulation 2016679 GDPR must be provided in regard to possible transfer of data from EU to USAIsraelSwitzerland8 In case personal data are transferred from a nonEU country to the EU USAIsraelSwitzerland to the EU partners confirmation that such transfers comply with the laws of the country in which the data was collected must be providedThe applicant must explain if any research activities to be performed in a nonEU country will result in transfers of data or materials tofrom nonEU countries If this is the case the concerned consortium members must provide details on the materials eg smart tags which will be imported toexported intofrom the EU and confirm that the adequate importexport authorisations required by nationalEU legislation have been obtained prior to the start of the research activity raising ethics issue and are kept on file and provided to IMI JU upon request

Data management plan mid-term. (odnośnik otworzy się w nowym oknie)

Data management plan midtermUpdate of the data management planThe consortium must address the following data protection issues in the Data Management Plan especially sections 4 Data security and 5 Ethics1 The consortium members must confirm that contact details of the Data Protection Officer DPO are made available to all data subjects involved in the research For the members of the consortium not required to appoint a DPO under the General Data Protection Regulation a detailed data protection policy for the project must be elaborated and kept on file It must be provided to IMI JU upon request2 The concerned consortium members must check and confirm to IMI JU if special derogations pertaining to the rights of data subjects or the processing of personal data have been established under the national legislation of the country where the research takes place and provide a declaration of compliance with respective national legal frameworks3 Details of the observationtracking activities such as shadowing of healthcare personnel and tracking patients with the electronic tags attached to drug containers must be provided The applicant must explain if these activities will involve personal data collectionprocessing 4 A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjectsresearch participants must be provided5 Detailed information on the specific data protection informed consent procedures in regard to data processing must be provided prior to the start of the research activity raising ethics issue in case this is not addressed in the informed consent procedures for human participants6 A description of the anonymisationpseudonymisation techniques that will implemented must be provided7 In case personal data are transferred from the EU to a nonEU country or international organisation confirmation that such transfers are in accordance with Chapter V of the General Data Protection Regulation 2016679 GDPR must be provided in regard to possible transfer of data from EU to USAIsraelSwitzerland8 In case personal data are transferred from a nonEU country to the EU USAIsraelSwitzerland to the EU partners confirmation that such transfers comply with the laws of the country in which the data was collected must be providedThe applicant must explain if any research activities to be performed in a nonEU country will result in transfers of data or materials tofrom nonEU countries If this is the case the concerned consortium members must provide details on the materials eg smart tags which will be imported toexported intofrom the EU and confirm that the adequate importexport authorisations required by nationalEU legislation have been obtained prior to the start of the research activity raising ethics issue and are kept on file and provided to IMI JU upon request

Project Website. (odnośnik otworzy się w nowym oknie)

Project WebsiteA publicly accessible webpage with information on the consortium its objectives and partners Providing information for the general audience as well as for specialists in the field

Publikacje

Examination of the Protein Drug Supply Chain in a Swedish University Hospital: Focus on Handling Risks and Mitigation Measures (odnośnik otworzy się w nowym oknie)

Autorzy: Clàudia Sabaté Martínez, Leanne Amery, Giorgia De Paoli, Ulla Elofsson, Anna Millqvist Fureby, Stanley Kwok, Carmen López-Cabezas, Marika Rosenberger, Christian Schoenau, Marie Wahlgren, Mattias Paulsson
Opublikowane w: Journal of Pharmaceutical Sciences, 2023, ISSN 0022-3549
Wydawca: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2023.05.003

Interdomain Interactions Modulate Refolding Kinetics and Aggregation in a Monoclonal Antibody (odnośnik otworzy się w nowym oknie)

Autorzy: Philipp Trolese, Andrea Pierangelini, Benedetta Fongaro, Patrizia Polverino de Laureto
Opublikowane w: Journal of the American Society for Mass Spectrometry, 2025, ISSN 1044-0305
Wydawca: Elsevier BV
DOI: 10.1021/jasms.5c00166

Relationships between surface tensiometry properties and fluorescence intensity of dark and light exposed monoclonal antibody Nivolumab/Opdivo® by using the contact angle method: A pilot study (odnośnik otworzy się w nowym oknie)

Autorzy: Giorgia Miolo, Elisabetta De Diana, Patrizia Polverino de Laureto, Nicola Realdon, Sergio Rossi, Davide Rossi
Opublikowane w: Journal of Pharmaceutical Sciences, Numer 114, 2025, Strona(/y) 103823, ISSN 0022-3549
Wydawca: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2025.103823

Managing antibody stability: Effects of stressors on Ipilimumab from the commercial formulation to diluted solutions (odnośnik otworzy się w nowym oknie)

Autorzy: Benedetta Fongaro, Valentina Cian, Francesca Gabaldo, Giorgia De Paoli, Giorgia Miolo, Patrizia Polverino de Laureto
Opublikowane w: European Journal of Pharmaceutics and Biopharmaceutics, 2022, ISSN 0939-6411
Wydawca: Elsevier BV
DOI: 10.1016/j.ejpb.2022.05.005

Towards a better understanding of light-glucose induced modifications on the structure and biological activity of formulated Nivolumab (odnośnik otworzy się w nowym oknie)

Autorzy: Elisabetta De Diana, Elena Rizzotto, Ilenia Inciardi, Luca Menilli, Marina Coppola, Patrizia Polverino de Laureto, Giorgia Miolo
Opublikowane w: International Journal of Pharmaceutics, Numer 654, 2024, Strona(/y) 123926, ISSN 0378-5173
Wydawca: Elsevier BV
DOI: 10.1016/j.ijpharm.2024.123926

Exploring industry stakeholder perspectives on a clinical testbed for evaluating the handling of protein drugs in hospitals (odnośnik otworzy się w nowym oknie)

Autorzy: Jesper Arvidsson, Yaser Alkhatib, Marc Egen, Ulla Elofsson, Anna Fureby Millqvist, Carmen López-Cabezas, Marie Wahlgren, Marika Rosenberger, Mattias Paulsson
Opublikowane w: Journal of Pharmaceutical Sciences, Numer 114, 2025, Strona(/y) 103704, ISSN 0022-3549
Wydawca: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2025.103704

Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity (odnośnik otworzy się w nowym oknie)

Autorzy: Elia Cappelletto, Stanley C. Kwok, Léa Sorret, Nathalie Fuentes, Annette M. Medina, Stephen Burleigh, Jonas Fast, Isla S. Mackenzie, Anna Millqvist Fureby, Mattias Paulsson, Marie Wahlgren, Ulla Elofsson, Angela Flynn, Giorgia Miolo, Lina Nyström, Patrizia Polverino De Laureto, Giorgia De Paoli
Opublikowane w: Journal of Pharmaceutical Sciences, Numer 113, 2024, Strona(/y) 2055-2064, ISSN 0022-3549
Wydawca: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2024.05.027

Light exacerbates local and global effects induced by pH unfolding of Ipilimumab (odnośnik otworzy się w nowym oknie)

Autorzy: Elena Rizzotto, Ilenia Inciardi, Benedetta Fongaro, Philipp Trolese, Giorgia Miolo, Patrizia Polverino de Laureto
Opublikowane w: European Journal of Pharmaceutics and Biopharmaceutics, Numer 201, 2024, Strona(/y) 114387, ISSN 0939-6411
Wydawca: Elsevier BV
DOI: 10.1016/j.ejpb.2024.114387

How are we handling protein drugs in hospitals? A human factors and systems engineering approach to compare two hospitals and suggest a best practice (odnośnik otworzy się w nowym oknie)

Autorzy: Clàudia Sabaté-Martínez, Mattias Paulsson, Silvia González-Suárez, Ulla Elofsson, Anna Millqvist Fureby, Marie Wahlgren, Carmen López-Cabezas
Opublikowane w: International Journal for Quality in Health Care, Numer 36, 2024, ISSN 1353-4505
Wydawca: Oxford University Press
DOI: 10.1093/intqhc/mzae020

Pneumatic tube transport of trastuzumab in IV bags—Effect of headspace and surfactant on subvisible particle formation (odnośnik otworzy się w nowym oknie)

Autorzy: Anna Kjellström, Ida Cederwall, Clàudia Sabaté Martínez, Stanley Kwok, Florian Rosenthal, Ulla Elofsson, Mattias Paulsson, Marie Wahlgren
Opublikowane w: Journal of Pharmaceutical Sciences, Numer 114, 2025, Strona(/y) 1142-1151, ISSN 0022-3549
Wydawca: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2024.12.003

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