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Here you will find, among other things, information and references to current courses of the KKS Magdeburg, new public funding opportunities (BMBF, DFG, etc) as well as events and other information on the topic of academic research.
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Courses from KKS Magdeburg The KKS Magdeburg offers the following need-based training courses. AMG refresher course |
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Current Public Grants (BMBF / DFG) Public funding opportunities, in particular for clinical studies/clinical trials with drugs or medical devices (Investigator Initiated Trials/IITs) Do you have a project idea?! We will gladly support you with the application together with the Referat für Forschung. Please also involve us as early as possible before submitting an initial project outline/idea or an application. This is particularly necessary if you are planning a clinical trial with a drug or medical device (IIT) for which the OvGU, Faculty of Medicine, must act as a sponsor by law (AMG, MPDG). |
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Events Clinical and Health Services Research You can also find more events here: http://www.med.uni-magdeburg.de/Forschung.html
- TMF: Kick-off Meeting der AG Register Berlin: 08.02.2023 (13:00-16:00 Uhr) The TMF starts a new working group on registries. The kick-off meeting will take place in Berlin. Among other things, it will be about current impulses as well as the collection of topics and the work plan for the new WG Register. Registration: https://eveeno.com/244041460
- DGPharMed: Workshop IT-Validierung Frankfurt: 08.03.2023 DGPharMed is organizing a workshop on IT validation in March that will focus on new guidelines, technologies, and the exchange of experiences: - How to qualify infrastructure in a cloud environment (IaaS)? - What depth of validation is required? - What do the new guidelines such as GAMP 5 (rev2), Computer System Assurance (FDA), and EMA guidelines mean for validation? - What is necessary for a coherent IT study documentation (e.g. eCRF, IRT, ePRO)? - Identification of common stumbling blocks - Inspection readiness: documentation with IT reference (e.g. eTMF)? For more information, see:
- DVMD: Spring Symposium with focus on "Medical Registers Munich: 21.03.2023 The spring symposium of the German Association for Documentation and Information Management in Medicine (DVMD) will focus on the requirements and challenges for documentation and information management for medical registries. Among other things, the conference program will take a closer look at different registers and describe their structure and possible uses. To ensure the desired practical relevance, the focus will also be on concrete recommendations for action and different digitization strategies for the necessary networking of registers will be presented. Furthermore, the participants will be informed about the implementation of new registers. The program and more information can be found at: https://dvmd.de/wp-content/uploads/2023/01/Programm_DVMD-Symposium2023.pdf https://dvmd.de/events/4-dvmd-fruehjahrssymposium - EbM Network: EbM Congress "Health and Climate - EbM for the Future". Potsdam and virtual: 22-24.03.2023 The EbM Congress 2023 will take place under the motto "Health and Climate - EbM for the Future" from 22-24 March 2023 in Potsdam. Registration is already open and the early bird rate is valid up to and including January 14, 2023 More information and registration: : https://www.ebm-kongress.de/ - DIA: DIA Europe 2023 Basel: 22.-24.03.2023 The DIA Europe Congress will take place from March 22 to 24 in Basel. This year the following topics will be covered: • Artificial Intelligence and Data Science • EU Health Policy and Regulatory Strategy • Medical Devices and Combination Products • Professional Development You can find more information at: https://www.diaglobal.org/en/flagship/dia-europe-2023/about/conference - TMF: Registertage – Save the date Berlin: 08/09.05.2023 The TMF Register Days will take place in Berlin on May 08 and 09, 2023. The congress is thematically aimed at the professional community of registry operators and researchers. Register researchers to discuss current developments and challenges for medical registers in health services research together with politics and industry and to exchange approaches for the further development of the registered landscape. For more information, please visit: https://tmf-ev.de/Termine/ctl/Details/Mid/785/ItemID/1706.aspx http://www.med.uni-magdeburg.de/Forschung.html - BPI und KKS-Netzwerk: Workshop Investigator Initiated Trials Berlin: 11.01.2023 Die Unterstützung von akademischen IITs – Investigator Initiated Trials ist mittlerweile im Alltag vieler pharmazeutischer Unternehmen und Medizinproduktehersteller ein fester Bestandteil geworden. Durch partnerschaftliche Kooperationen zwischen Ärzten und Herstellern können in wissenschaftsinitiierten Studien Erkenntnisse gewonnen werden, die sowohl der Patientenversorgung zugutekommen als auch wichtige Informationen für den Hersteller generieren. Vor diesem Hintergrund tauchen immer wieder auf beiden Seiten Fragen zur konkreten Umsetzung auf. Neben den unterschiedlichen Möglichkeiten einer Beteiligung an Kooperationsprojekten ist von besonderem Interesse, wie eine Unterstützung von IITs durch Hersteller unter Einhaltung regulatorischer und beihilferechtlicher Vorgaben realisiert werden kann. Programm: https://www.kks-netzwerk.de/veranstaltungen/gemeinsameveranstaltungen/ - EbM Network: EbM Congress "Health and Climate - EbM for the Future“ Potsdam and virtuel: 22.-24.03.2023 The EbM Congress 2023 will take place under the motto "Health and Climate - EbM for the Future" from 22-24 March 2023 in Potsdam. Registration is already open and the early bird rate is valid up to and including January 14, 2023 More information and registration: : https://www.ebm-kongress.de/ - TMF/GBN: 11. National Biobank Symposium - Call for Papers Berlin: 25.-26.05.2023 in Berlin Researchers from all disciplines, biobank operators and industry are cordially invited to actively participate in shaping the symposium with presentations and posters on the following topics: 1. Future Directions of Biobanking 2. Requirements and technologies 3. IT 4. international biobanking 5. ethics, data protection, regulations 6. shortage of skilled workers, global supply chains, energy crisis (cost structures) 7. scientific benefits of biobanking, scientific results & success stories Deadline: 22.01.2023 https://www.tmf-ev.de/News/articleType/ArticleView/articleId/4891.aspx
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Other information - BMG: Amendment of the Special Fee Schedule The BMG's Special Fee Schedule was adjusted in January 2023. The fee framework for the evaluation of "Transitional Trials" according to Regulation (EU) No. 536/2014 is now also specified here (Annex Section 5). The amount of the fees is specified as 500 to 5700 euros.
https://www.gesetze-im-internet.de/bmgbgebv/index.html#BJNR439100021BJNE000702116
- Federal funding approved for gene and cell therapy center At the end of 2022, the Budget Committee of the German Parliament decided that four million euros would be made available by the federal government in 2023 for the establishment of a center for gene and cell therapy in Berlin. In the medium term, more than 40 million euros are to be made available. The federal funds will be used for planning in the coming years - for example, for an architectural tender, workshops, and the development of a national strategy for gene and cell therapies. For more information, see the news section of the Ärzteblatt:
- DFG: DFG: Publication of final reports In order to broaden the scientific information base and contribute to the necessary cultural change in scientific publishing, final reports of DFG projects are to be made more accessible. In the future, grant recipients will be asked to make a part of the final report intended for publication available in suitable repositories. The publication will be supported by corresponding templates that specify a structuring into a part intended for publication and a non-public part. Provided that the authors of the final reports provide the DFG with the link to the location in the selected repository, the reports will be searchable and retrievable via the GEPRIS information system. https://www.dfg.de/foerderung/info_wissenschaft/2023/info_wissenschaft_23_01/index.html
- BfArM/PEI: Joint recommendations on the notification of observational studies and non-interventional safety studiesn
Regulation (EU) 536/2014 introduced a new definition for non-interventional studies, which was also incorporated into the German Medicines Act. The new definition of non-interventional studies is the reason for the revision of the joint recommendations of the BfArM and the PEI on the obligation to notify post-authorisation safety studies (PASS). The recommendations jointly issued by BfArM and PEI on post-authorization safety studies and non-interventional safety studies dated December 20, 2019, will be repealed and replaced by the "Joint Recommendations of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute on the Notification of Post-Authorization Safety Studies Pursuant to Section 67(6) of the German Medicines Act and on the Notification of Non-interventional Safety Studies Pursuant to Section 63f of the German Medicines Act" dated December 15, 2022.
https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Nichtinterventionelle-Studien/_artikel.html
- BfArM: Application for a decision on the obligation to approve a clinical trial of a medical device
If the regulatory classification of a planned clinical trial or performance study cannot be clarified, the parties involved in the conduct, approval, or monitoring of the clinical trial/performance study may submit an application for a decision on the requirement for approval to the higher federal authority in accordance with Section 6 (3) MPDG. Information on the application for a decision on the obligation to obtain approval is compiled on the BfArM website:
- PEI: Pilotphase 2 des Simultaneous National Advice (SNSA) startet ab 2023
The aim of the pilot project is to make drug developers increasingly aware of the benefits of the SNSA - particularly with regard to innovative developments from academia and industry - and to demonstrate the potential added value of the joint consulting concept in order to make the project permanent on the basis of a best-practice model. The focus of the scientific consultations in phase 2 of the SNSA pilot project is on clinical trials in the EU.
- AKEK: Handout on certificates and webinars
The Working Group of Medical Ethics Committees has published a handout on certificates and webinars. This gives recommendations on the information required on training certificates for continuing education courses for investigators and members of an investigative team, as well as guidance on physical or virtual face-to-face events or eLearning. https://www.akek.de/wp-content/uploads/2022-11-04_Handreichung-zu-Zertifikaten-Webinare.pdf In addition, FAQs on curricular training courses for examiners and members of an examination team/group have been published: https://www.akek.de/wp-content/uploads/2022-12-09_FAQ_final.pdf
- AKEK: New sample texts patients/test persons in clinical studies according to CTR and AMG (old version) according to resolution of 25.11.20022
New sample texts on patient consent (patient, proband) for applications according to CTR and applications according to AMG (old version) were adopted by the AKEK and published on the website. In addition, a handout for the ethics committees was published, which deals with the procedure for research with data and samples in the context of clinical trials according to the CTR.
https://www.akek.de/arzneimittelgesetz-amg/
- AKEK: Checklist of documents to be submitted for PMCF studies
Eine Checkliste der einzureichenden Unterlagen bei PMCF-Studien wurde ebenfalls auf der Website des AKEK veröffentlicht.
https://www.akek.de/medizinproduktegesetz-mpg/
- MII: Announcement for commenting on the core data record module medication from 02.01.2023 onwards
For the common, cross-institutional use of data, a core data set is defined within the MII, which is subdivided into modules grouped by content and implemented by all MII sites. The Medication module contains data elements for documenting medication prescriptions and administration as well as medication schedules. It is part of the basic modules of the MII's core data set. In early 2020, the Medication module was reconciled in version 1.0 and has since been implemented in the MII's data integration centers. Beginning January 2, 2023, and ending February 28, 2023, the module's enhanced specification, Version 2.0, will be available for comment.
- EMA: Recommendation paper on decentralised elements in clinical trials
On December 13, the Recommendation Paper on decentralized elements in clinical trials was published by the EMA. The recommendations cover aspects such as oversight, patient consent, supply and administration of investigational medicines, study-specific procedures, data collection and management (including handling of source data), and monitoring. In addition, an overview of national regulations for specific DCT elements is included in the appendix.
- Bundesgesundheitsblatt: First experiences with the implementation of EU Regulation 536/2014 (CTR) from the perspective of non-commercial academic research.
Under the lead topic "How is the EU regulation on clinical trials of medicinal products evaluated one year after its launch?" various stakeholders report on their experiences in the Bundesgesundheitsblatt
- BfArM: Data protection criteria for digital health apps and digital care apps The BfArM has published new test criteria for data protection requirements for digital health applications (DiGA) and digital care applications (DiPA). In the future, these criteria will form the basis for new certificates with which manufacturers of health and care apps can prove that their apps are data protection-compliant. They cover both the requirements of the European General Data Protection Regulation and the extended requirements for DiGA and DiPA.
https://www.bfarm.de/DE/Medizinprodukte/Aufgaben/DiGA-und-DiPA/Datenschutzkriterien/_artikel.html
- EMA: Pilot project to support academic developers of ATMPs. In a new pilot project, the EMA would like to support the development of ATMPs. The pilot project is aimed specifically at academic sponsors and non-profit organizations. The EMA will provide enhanced regulatory support for up to five selected ATMPs developed exclusively by academic and non-profit organizations in Europe. Potential candidates can contact their national competent authority or the EMA ( ) to express their interest in participating in the pilot project or to obtain further information.
- EMA: CTIS As of January 31, 2023, all initial applications for clinical trials in the European Union (EU) must be submitted through the Clinical Trials Information System (CTIS).
- ICH: Guideline on the selective use of safety data collection in certain clinical trials
Die ICH Guideline E19 (selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials) was on 16. September 2022 through the CHMP accepted. As of March 16, 2023, this guideline will be in effect.
- ICH Q9 Quality risk management (R1) published IIn our news of December 14, 2020, we had reported on the announcement by the International Council for Harmonisation (ICH) to revise the ICH Q9 Quality Risk Management Guidelines. The final version has now been published. https://www.ich.org/page/quality-guidelines |
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KKS documents for study planning in study centers. We will gladly provide you with forms and SOPs in the Intranetzur . |
