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X-WR-CALNAME:GKM Gesellschaft für Therapieforschung mbH | Full-service CRO
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X-WR-CALDESC:Events for GKM Gesellschaft für Therapieforschung mbH | Full-service CRO
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20200619
DTEND;VALUE=DATE:20200620
DTSTAMP:20260513T203924
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:20260513T203924
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:20260513T203924
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:20260513T203924
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:20260513T203924
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:20260513T203924
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:20260513T203924
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:20260513T203924
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:20260513T203924
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
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