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

Project Information

RealHOPE

Grant agreement ID: 101007939

DOI 10.3030/101007939

EC signature date 5 July 2021

Start date 1 July 2021

End date 30 June 2025

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost € 7 132 608,75

EU contribution € 3 139 983,75

Coordinated by

RISE RESEARCH INSTITUTES OF SWEDEN AB
Sweden

Deliverables

Open Research Data Pilot (2)

First version of data management plan.

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.

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

Websites, patent fillings, videos etc. (1)

Project Website.

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

Publications

Peer reviewed articles (2)

Examination of the Protein Drug Supply Chain in a Swedish University Hospital: Focus on Handling Risks and Mitigation Measures

Author(s): 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
Published in: Journal of Pharmaceutical Sciences, 2023, ISSN 0022-3549
Publisher: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2023.05.003

Managing antibody stability: Effects of stressors on Ipilimumab from the commercial formulation to diluted solutions

Author(s): Benedetta Fongaro, Valentina Cian, Francesca Gabaldo, Giorgia De Paoli, Giorgia Miolo, Patrizia Polverino de Laureto
Published in: European Journal of Pharmaceutics and Biopharmaceutics, 2022, ISSN 0939-6411
Publisher: Elsevier BV
DOI: 10.1016/j.ejpb.2022.05.005