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BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20241010T103000
DTEND;TZID=Europe/Berlin:20241010T113000
DTSTAMP:20260411T014837
CREATED:20240805T113833Z
LAST-MODIFIED:20240807T064827Z
UID:8144-1728556200-1728559800@www.gkm-therapieforschung.de
SUMMARY:Webinar Clincase EDC - Bringing precision and efficiency to your clinical studies
DESCRIPTION:  \nWe are pleased to invite you to this webinar to find out about the latest developments in Electronic Data Capture (EDC) systems for clinical research. \nAs a full service CRO offering services throughout the entire clinical development\, we understand the critical role of EDC in ensuring the success of clinical studies and are committed to providing the most efficient and high-quality solutions. With this in mind\, we have organised a webinar together with one of our EDC suppliers\, our longstanding partner Clincase\, for you to find out about the latest developments in EDC systems for clinical research. \nRegister now to learn about new features in Clincase and how you can use them to optimise your clinical trials: \n\nSimplify local lab management for site teams\nUpdating of brand colours and a more modernized interface\nEnable self-configured dashboard with multiple pages in the new reporting and dashboard.\n\nAfter the webinar\, you will have the opportunity to ask our Clincase experts any questions you may have. \nWe look forward to your registration! \nWebinar registration
URL:https://www.gkm-therapieforschung.de/en/event/webinar-clincase-edc-bringing-precision-and-efficiency-to-your-clinical-studies/
LOCATION:Live demo webinar via Teams
CATEGORIES:Online-Seminar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20220720T150000
DTEND;TZID=Europe/Berlin:20220720T160000
DTSTAMP:20260411T014837
CREATED:20220620T092618Z
LAST-MODIFIED:20220621T163910Z
UID:6923-1658329200-1658332800@www.gkm-therapieforschung.de
SUMMARY:Webinar: EU Clinical Trial Regulation 536/2014 (CTR): Was ist bei der Umsetzung zu beachten?
DESCRIPTION:In German language: \nSeit dem 31.01.2022 ist die Clinical Trial Regulation 536/2014 (CTR) in der Praxis anwendbar. Es gibt eine Übergangsfrist von drei Jahren\, in der sowohl die EU Richtlinie 2001/20 als auch die EU Verordnung 536/2014 parallel laufen. Dieses praxisorientierte Webinar richtet sich an Sponsoren\, die sich Klarheit über die wichtigsten Änderungen und Anforderungen im Rahmen der EU CTR sowie der Übergangsphase verschaffen wollen. Zudem bietet es die Chance\, Fragen zu stellen und sich auszutauschen. \nAnmeldung hier: \nhttps://forms.gle/ztAKmpgVACiq36sy9
URL:https://www.gkm-therapieforschung.de/en/event/webinar-eu-clinical-trial-regulation-536-2014-ctr-what-to-consider-during-implementation-in-german/
CATEGORIES:Online-Seminar
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220501
DTEND;VALUE=DATE:20220502
DTSTAMP:20260411T014837
CREATED:20220104T182547Z
LAST-MODIFIED:20220104T182847Z
UID:6839-1651363200-1651449599@www.gkm-therapieforschung.de
SUMMARY:Clinical trials of medical devices
DESCRIPTION:Medical devices have to be safe and efficient. Appropriate clinical data are required to substantiate this. Dr. Andrea Röthler gives a lecture in an online event on the subject of clinical trials with medical devices: \nPMCF studies\, planned date April / May 2022
URL:https://www.gkm-therapieforschung.de/en/event/clinical-trials-of-medical-devices/
LOCATION:Live demo webinar via Teams
CATEGORIES:Online-Seminar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20220412T140000
DTEND;TZID=Europe/Berlin:20220412T153000
DTSTAMP:20260411T014837
CREATED:20220103T122803Z
LAST-MODIFIED:20220103T123209Z
UID:6825-1649772000-1649777400@www.gkm-therapieforschung.de
SUMMARY:PharmaFORUM Webcast Medical Affairs
DESCRIPTION:One live webcast per month with proven experts from medical affairs with the possibility of discussion via audio and chat. Practical information in short periods of time at your workplace or on the go. Live broadcast available afterwards. Lecture documents can be downloaded. You participate in your device from different locations. You can see the presentation documents and hear the talk of our speakers. You also have the opportunity to ask questions before and during the webcast\, which our speakers will be happy to answer individually. \nApril 12th\, 2021\, 2 p.m. \nRupert Lang\, Chief Operations Officer GKM\, on application monitoring (study synopsis\, notification\, ethics vote\, etc.)
URL:https://www.gkm-therapieforschung.de/en/event/pharmaforum-webcast-medical-affairs/
LOCATION:Live demo webinar via Teams
CATEGORIES:Online-Seminar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20220406T130000
DTEND;TZID=Europe/Berlin:20220406T173000
DTSTAMP:20260411T014837
CREATED:20220110T175725Z
LAST-MODIFIED:20220110T175725Z
UID:6860-1649250000-1649266200@www.gkm-therapieforschung.de
SUMMARY:clinical requirements
DESCRIPTION:MEGRA\, start-up medical devices and MDR \nAn online course with 8 modules from 1:00 p.m. to 5:30 p.m.\nDr. Andrea Röthler gives a lecture on the subject of clinical requirements. \nModule 5: Clinical Requirements \nWednesday\, April 6th\, 2022 \nSpeakers:\nDr. Raymond Nistor (QMD Services GmbH)\nDr. Andrea Röthler (GKM Society for Therapy Research) \nSubjects: \n\nClinical testing\, classification and categorization\nWhich requirements must clinical data meet for which purpose?\n\nDo you want to know more?\nThen download the entire MEGRA e.V. program here.
URL:https://www.gkm-therapieforschung.de/en/event/clinical-requirements/
LOCATION:Live demo webinar via Teams
CATEGORIES:Online-Seminar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20220330T150000
DTEND;TZID=Europe/Berlin:20220330T160000
DTSTAMP:20260411T014837
CREATED:20220314T133137Z
LAST-MODIFIED:20220314T133137Z
UID:6892-1648652400-1648656000@www.gkm-therapieforschung.de
SUMMARY:Studie läuft\, aber wo bleiben die Patienten?
DESCRIPTION:In German language: \nDeepDive in Online-Patientenrekrutierung \nDie Patientenrekrutierung bei klinischen Studien kann herausfordernd sein. In diesem Webinar diskutieren Dr. Andrea Röthler\, Abteilungsleiterin Projektmanagement der Gesellschaft für Therapieforschung mbH\, und Dr. Tobias Kruse\, CEO Trials24\, über Hürden und Möglichkeiten der dezentralen Patientenrekrutierung\, außerhalb der Prüfzentren. Das praxisnahe Webinar richtet sich an Sponsoren\, die sich über die Online-Patientenrekrutierung informieren wollen und bietet die Chance eines interaktiven Austausches. \nAnmeldung per LinkedIn \nAnmeldung per Anmeldeformular
URL:https://www.gkm-therapieforschung.de/en/event/studie-laeuft-aber-wo-bleiben-die-patienten/
LOCATION:Live demo webinar via Teams
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20211126
DTEND;VALUE=DATE:20211127
DTSTAMP:20260411T014837
CREATED:20211018T090959Z
LAST-MODIFIED:20211018T090959Z
UID:6732-1637884800-1637971199@www.gkm-therapieforschung.de
SUMMARY:29th BVMA Symposium 2021
DESCRIPTION:Meet us at the 29th BVMA Symposium in Garching.
URL:https://www.gkm-therapieforschung.de/en/event/29th-bvma-symposium-2021/
LOCATION:Science Congress Center Munich\, Walther-von-Dyck-Straße 10\, Garching\, 85748\, Deutschland
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20210520T160000
DTEND;TZID=Europe/Berlin:20210520T170000
DTSTAMP:20260411T014837
CREATED:20210519T100200Z
LAST-MODIFIED:20210519T100200Z
UID:6708-1621526400-1621530000@www.gkm-therapieforschung.de
SUMMARY:Keynote lecture "Successfully mastering PMCF studies in the context of clinical follow-up"
DESCRIPTION:With the EU MDR\, manufacturers must continuously collect clinical data on the performance and safety of their medical devices even after they have been placed on the market. But how do you master PMCF studies in the context of clinical follow-up? In our second informal “MedTech Connect” exchange\, it’s all about the PMCF phase\, which is immensely important in post-market surveillance. Learn what PMCF should ideally look like\, under what conditions manufacturers need to conduct PMCF studies\, and how they can make these types of studies a success by following simple ground rules. Together with the GKM Society for Therapy Research we offer you an exciting impulse lecture as well as a space to bring your experiences and problems and to exchange ideas. \nDr. Andrea Röthler (head of project management and head of the section medical devices at GKM Gesellschaft für Therapieforschung) leads the workshop “Registration of Medical Devices” \nThe event will be in German\, only.
URL:https://www.gkm-therapieforschung.de/en/event/keynote-lecture-successfully-mastering-pmcf-studies-in-the-context-of-clinical-follow-up/
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20201127
DTEND;VALUE=DATE:20201128
DTSTAMP:20260411T014837
CREATED:20200102T162940Z
LAST-MODIFIED:20200102T164453Z
UID:6492-1606435200-1606521599@www.gkm-therapieforschung.de
SUMMARY:28th BVMA Symposium 2020
DESCRIPTION:Meet us at the 28th BVMA Symposium in Munich. Topics come soon.
URL:https://www.gkm-therapieforschung.de/en/event/28th-bvma-symposium-2020/
LOCATION:Sheraton München\, Arabellapark Hotel\, Arabellastr. 5\, München\, 81925
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20201125
DTEND;VALUE=DATE:20201127
DTSTAMP:20260411T014837
CREATED:20200102T163903Z
LAST-MODIFIED:20200102T164157Z
UID:6494-1606262400-1606435199@www.gkm-therapieforschung.de
SUMMARY:Praxis-Workshop: Market authorization of medical devices
DESCRIPTION:After the adoption of the new Medical Device Regulation (MDR) by the European Parliament\, many manufacturers and distributors of medical devices have already started to adapt their processes. However\, although the implementation period for the MDR ends in 2020\, many companies still need information about the effects of the new MDR and how the approval of medical devices will work in the future. This practical workshop closes this information gap and accompanies you step-by-step and through practical examples through the entire process of approval of medical devices.   \nOn the first day you will learn which regulatory requirements you as a manufacturer or distributor of medical devices have to meet\, how the CE marking process works\, how to obtain a clinical evaluation and what you need to consider after placing the medical device on the market. The role of the certified bodies and authorities is explained as well as the tasks of internal monitoring.   \nThe second day focuses on the implementation of the regulatory requirements in the company. Using the example of a specific medical device\, you will get to know the new processes from start to finish. \n \nHot topics \n\n\n\nInnovations in the current medical device regulation \n\n\nLegal basis \n\n\nThe CE marking process using a concrete example \n\n\nCreation of a technical documentation \n\n\nStructure and processes of a quality management system \n\n\nClinical evaluation process \n\n\n \n\nProgram .pdf download here please >>
URL:https://www.gkm-therapieforschung.de/en/event/praxis-workshop-market-authorization-of-medical-devices-3/
LOCATION:Hotel NH Potsdam\, Friedrich-Ebert-Straße 88\, Potsdam\, 14467\, Deutschland
CATEGORIES:Praxis-Workshop
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20201123
DTEND;VALUE=DATE:20201124
DTSTAMP:20260411T014837
CREATED:20201007T125719Z
LAST-MODIFIED:20201007T125719Z
UID:6598-1606089600-1606175999@www.gkm-therapieforschung.de
SUMMARY:DVMD-Symposium clinical research
DESCRIPTION:Adapted to the ongoing pandemic\, the symposium will be held online via zoom.\nIt is dedicated to current topics in clinical research\, including big data\, ePRO and risk-based monitoring. \nDespite or perhaps because of the online format\, discussions\, question and answer sessions and virtual coffee tables are made possible.\nLet yourself be surprised and look forward to exchanging ideas with colleagues.
URL:https://www.gkm-therapieforschung.de/en/event/dvmd-symposium-clinical-research/
CATEGORIES:Online-Seminar
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20200715
DTEND;VALUE=DATE:20200717
DTSTAMP:20260411T014837
CREATED:20200102T162341Z
LAST-MODIFIED:20200102T162722Z
UID:6487-1594771200-1594943999@www.gkm-therapieforschung.de
SUMMARY:Praxis-Workshop: Market authorization of medical devices
DESCRIPTION:After the adoption of the new Medical Device Regulation (MDR) by the European Parliament\, many manufacturers and distributors of medical devices have already started to adapt their processes. However\, although the implementation period for the MDR ends in 2020\, many companies still need information about the effects of the new MDR and how the approval of medical devices will work in the future. This practical workshop closes this information gap and accompanies you step-by-step and through practical examples through the entire process of approval of medical devices.   \nOn the first day you will learn which regulatory requirements you as a manufacturer or distributor of medical devices have to meet\, how the CE marking process works\, how to obtain a clinical evaluation and what you need to consider after placing the medical device on the market. The role of the certified bodies and authorities is explained as well as the tasks of internal monitoring.   \nThe second day focuses on the implementation of the regulatory requirements in the company. Using the example of a specific medical device\, you will get to know the new processes from start to finish. \n \nHot topics \n\n\n\nInnovations in the current medical device regulation \n\n\nLegal basis \n\n\nThe CE marking process using a concrete example \n\n\nCreation of a technical documentation \n\n\nStructure and processes of a quality management system \n\n\nClinical evaluation process \n\n\n \n\nProgram .pdf download here please >>
URL:https://www.gkm-therapieforschung.de/en/event/praxis-workshop-market-authorization-of-medical-devices-2/
LOCATION:Mercure Hotel Stuttgart Airport Messe\, Eichwiesenring 1/1\, Stuttgart\, 70567\, Deutschland
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20200619
DTEND;VALUE=DATE:20200620
DTSTAMP:20260411T014837
CREATED:20200102T161920Z
LAST-MODIFIED:20200102T161920Z
UID:6485-1592524800-1592611199@www.gkm-therapieforschung.de
SUMMARY:IQWiG in Dialog
DESCRIPTION:Dialog event of the „Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen“ (IQWiG). 
URL:https://www.gkm-therapieforschung.de/en/event/iqwig-in-dialog/
LOCATION:Köln
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20200323
DTEND;VALUE=DATE:20200324
DTSTAMP:20260411T014837
CREATED:20200102T161540Z
LAST-MODIFIED:20200102T161540Z
UID:6484-1584921600-1585007999@www.gkm-therapieforschung.de
SUMMARY:Third spring symposium of the DVMD 2020
DESCRIPTION:The third spring symposium of the DVMD is dedicated to current topics in clinical research. These include big data\, ePRO and risk-based monitoring.
URL:https://www.gkm-therapieforschung.de/en/event/third-spring-symposium-of-the-dvmd-2020/
LOCATION:Hotel Novotel Muenchen City\, Hochstraße 11\, München\, 81669\, Deutschland
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20200318
DTEND;VALUE=DATE:20200320
DTSTAMP:20260411T014837
CREATED:20200102T160809Z
LAST-MODIFIED:20200102T161302Z
UID:6480-1584489600-1584662399@www.gkm-therapieforschung.de
SUMMARY:Praxis-Workshop: Market authorization of medical devices
DESCRIPTION:After the adoption of the new Medical Device Regulation (MDR) by the European Parliament\, many manufacturers and distributors of medical devices have already started to adapt their processes. However\, although the implementation period for the MDR ends in 2020\, many companies still need information about the effects of the new MDR and how the approval of medical devices will work in the future. This practical workshop closes this information gap and accompanies you step-by-step and through practical examples through the entire process of approval of medical devices.   \nOn the first day you will learn which regulatory requirements you as a manufacturer or distributor of medical devices have to meet\, how the CE marking process works\, how to obtain a clinical evaluation and what you need to consider after placing the medical device on the market. The role of the certified bodies and authorities is explained as well as the tasks of internal monitoring.   \nThe second day focuses on the implementation of the regulatory requirements in the company. Using the example of a specific medical device\, you will get to know the new processes from start to finish. \n \nHot topics \n\n\n\nInnovations in the current medical device regulation \n\n\nLegal basis \n\n\nThe CE marking process using a concrete example \n\n\nCreation of a technical documentation \n\n\nStructure and processes of a quality management system \n\n\nClinical evaluation process \n\n\n \n\nProgram .pdf please download here >>
URL:https://www.gkm-therapieforschung.de/en/event/praxis-workshop-market-authorization-of-medical-devices/
LOCATION:Hotel NH Düsseldorf City Nord\, Münsterstraße 230/238\, Düsseldorf\, 40470\, Deutschland
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20200312
DTEND;VALUE=DATE:20200314
DTSTAMP:20260411T014837
CREATED:20200102T155539Z
LAST-MODIFIED:20200102T155539Z
UID:6477-1583971200-1584143999@www.gkm-therapieforschung.de
SUMMARY:DGPharmMed Annual Meeting
DESCRIPTION:Visit us for two days with 7 symposia\, round table discussions and stimulating exchange with colleagues from various disciplines.
URL:https://www.gkm-therapieforschung.de/en/event/dgpharmmed-annual-meeting/
LOCATION:Ellington Hotel Berlin\, Nürnberger Str. 50-55\, Berlin\, 10789
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20200220
DTEND;VALUE=DATE:20200221
DTSTAMP:20260411T014837
CREATED:20200102T154000Z
LAST-MODIFIED:20200102T155804Z
UID:6474-1582156800-1582243199@www.gkm-therapieforschung.de
SUMMARY:Good Clinical Study Design
DESCRIPTION:Dr. Michael Obermeier\, Head of Biostatistics at GKM\, lectures at the FORUM seminar “Good Clinical Study Design”. \nThe study design is the basis for the successful completion of a clinical trial. However\, regulations\, guidelines for patient safety\, financial considerations and the practical feasibility set narrow limits to creativity. This seminar informs you about the regulatory framework and shows you how you should approach study planning and the definition of study design in a very practical way. \n\nWhat is the authority’s focus when assessing the design?\nHow do you proceed methodically on the planning timeline?\nWhich statistical considerations play a role?\nAnd how is the project assessed from an ethical perspective and in terms of patient safety?\n\nThis seminar focuses on innovative and complex study designs such as adaptive\, basket and umbrella\, which are becoming increasingly important for clinical trials. \nRead more: https://www.forum-institut.de/seminar/2002242-good-clinical-study-design
URL:https://www.gkm-therapieforschung.de/en/event/good-clinical-study-design/
LOCATION:Hotel Stadtpalais\, Deutz-Kalker-Str. 52\, Köln\, 50679\, Deutschland
CATEGORIES:Training
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20191204
DTEND;VALUE=DATE:20191207
DTSTAMP:20260411T014837
CREATED:20190212T164315Z
LAST-MODIFIED:20191120T204908Z
UID:5539-1575417600-1575676799@www.gkm-therapieforschung.de
SUMMARY:Compact seminar: Clinical Evaluation and Clinical Investigations of Medical Devices in Munich
DESCRIPTION:Dr. Andrea Röthler (head of project management and head of the section medical devices at GKM Gesellschaft für Therapieforschung) is one of the speakers at the training “Clinical evaluation and clinical investigations of medical devices”. \nThe event will be in German\, only.
URL:https://www.gkm-therapieforschung.de/en/event/compact-seminar-clinical-evaluation-and-clinical-investigations-of-medical-devices-5/
LOCATION:TÜV SÜD Akademie GmbH\, Training Center München\, Westendstraße 160\, 3. Stock\, München\, 80339
CATEGORIES:Training
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20191129
DTEND;VALUE=DATE:20191130
DTSTAMP:20260411T014837
CREATED:20190213T083053Z
LAST-MODIFIED:20190213T083053Z
UID:5543-1574985600-1575071999@www.gkm-therapieforschung.de
SUMMARY:27. BVMA-Symposium
DESCRIPTION:Under the topic “Digitizing clinical research – curse or blessing?”\, the symposium will shed light on different perspectives such as data protection\, sponsor’s and patient’s perspectives\, ethics and authorities in the form of a “round table”. \nOther topics are: \n\nRegulatory aspectes from EU and ICH / GCP\, the BMG as well as regarding the new medical device regulation\nInnovative technologies: patient apps\, eDiaries\, software as a medical device\nGood Practices from the point of view of the BfArM and regarding the multiple participation of subjects in Phase I studies\n\nWe look forward to meeting you at the symposium or at the “Get-together” the evening before in the event hotel! \nhttps://www.bvma.de/aktuelles-bvma-symposium/anmeldung-symposium/ \n  \n \n 
URL:https://www.gkm-therapieforschung.de/en/event/27-bvma-symposium/
LOCATION:Sheraton München\, Arabellapark Hotel\, Arabellastr. 5\, München\, 81925
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20191128
DTEND;VALUE=DATE:20191130
DTSTAMP:20260411T014837
CREATED:20190212T101436Z
LAST-MODIFIED:20191120T201024Z
UID:5523-1574899200-1575071999@www.gkm-therapieforschung.de
SUMMARY:Practical workshop: Registration of Medical Devices in Frankfurt
DESCRIPTION:Dr. Andrea Röthler (head of project management and head of the section medical devices at GKM Gesellschaft für Therapieforschung) leads the workshop “Registration of Medical Devices” \nThe event will be in German\, only.
URL:https://www.gkm-therapieforschung.de/en/event/practical-workshop-registration-of-medical-devices-2/
LOCATION:Relaxa Hotel Frankfurt\, Lurgiallee 2\, Frankfurt am Main\, 60439
CATEGORIES:Training
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20191121
DTEND;VALUE=DATE:20191123
DTSTAMP:20260411T014837
CREATED:20190213T084940Z
LAST-MODIFIED:20191120T201223Z
UID:5550-1574294400-1574467199@www.gkm-therapieforschung.de
SUMMARY:Training „Clinical Studies for Medical Devices – Qualification for study lead according to Medical Devices Act“ in Munich
DESCRIPTION:Dr. Andrea Röthler (head of project management and head of the section medical devices at GKM Gesellschaft für Therapieforschung) is one of the speakers at the course “Clinical studies for Medical Devices – Qualification for study leadership according to medical devices act”. \nThe event will be in German\, only.
URL:https://www.gkm-therapieforschung.de/en/event/training-clinical-studies-for-medical-devices-qualification-for-study-lead-according-to-medical-devices-act-3/
LOCATION:P.E.G.- DIE AKADEMIE\, Kreillerstr. 24\, München\, 81673\, Germany
CATEGORIES:Training
END:VEVENT
END:VCALENDAR