GKM Gesellschaft für Therapieforschung mbH | Full-service CRO

Webinar: EU Clinical Trial Regulation 536/2014 (CTR): Was ist bei der Umsetzung zu beachten?
2022-07-20 15:00 - 16:00 (Europe/Berlin)
In German language:
Seit 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.
Anmeldung hier:
https://forms.gle/ztAKmpgVACiq36sy9

Clinical trials of medical devices
2022-05-01 | Live demo webinar via Teams
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:
PMCF studies, planned date April / May 2022

PharmaFORUM Webcast Medical Affairs
2022-04-12 14:00 - 15:30 | Live demo webinar via Teams
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.
April 12th, 2021, 2 p.m.
Rupert Lang, Chief Operations Officer GKM, on application monitoring (study synopsis, notification, ethics vote, etc.)

clinical requirements
2022-04-06 13:00 - 17:30 | Live demo webinar via Teams
MEGRA, start-up medical devices and MDR
An online course with 8 modules from 1:00 p.m. to 5:30 p.m.
Dr. Andrea Röthler gives a lecture on the subject of clinical requirements.
Module 5: Clinical Requirements
Wednesday, April 6th, 2022
Speakers:
Dr. Raymond Nistor (QMD Services GmbH)
Dr. Andrea Röthler (GKM Society for Therapy Research)
Subjects:

Clinical testing, classification and categorization
Which requirements must clinical data meet for which purpose?

Do you want to know more?
Then download the entire MEGRA e.V. program here.

Studie läuft, aber wo bleiben die Patienten?
2022-03-30 15:00 - 16:00 | Live demo webinar via Teams
In German language:
DeepDive in Online-Patientenrekrutierung
Die 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.
Anmeldung per LinkedIn
Anmeldung per Anmeldeformular

29th BVMA Symposium 2021
2021-11-26 | Science Congress Center Munich, Walther-von-Dyck-Straße 10, Garching, 85748, Deutschland
Meet us at the 29th BVMA Symposium in Garching.

Keynote lecture "Successfully mastering PMCF studies in the context of clinical follow-up"
2021-05-20 16:00 - 17:00
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.
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”
The event will be in German, only.

28th BVMA Symposium 2020
2020-11-27 | Sheraton München, Arabellapark Hotel, Arabellastr. 5, München, 81925
Meet us at the 28th BVMA Symposium in Munich. Topics come soon.

Praxis-Workshop: Market authorization of medical devices
2020-11-25 - 2020-11-26 | Hotel NH Potsdam, Friedrich-Ebert-Straße 88, Potsdam, 14467, Deutschland
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.
On 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.
The 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.

Hot topics

Innovations in the current medical device regulation

Legal basis

The CE marking process using a concrete example

Creation of a technical documentation

Structure and processes of a quality management system

Clinical evaluation process

Program .pdf download here please >>

DVMD-Symposium clinical research
2020-11-23
Adapted to the ongoing pandemic, the symposium will be held online via zoom.
It is dedicated to current topics in clinical research, including big data, ePRO and risk-based monitoring.
Despite or perhaps because of the online format, discussions, question and answer sessions and virtual coffee tables are made possible.
Let yourself be surprised and look forward to exchanging ideas with colleagues.

Praxis-Workshop: Market authorization of medical devices
2020-07-15 - 2020-07-16 | Mercure Hotel Stuttgart Airport Messe, Eichwiesenring 1/1, Stuttgart, 70567, Deutschland

IQWiG in Dialog
2020-06-19 | Köln
Dialog event of the „Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen“ (IQWiG).

Third spring symposium of the DVMD 2020
2020-03-23 | Hotel Novotel Muenchen City, Hochstraße 11, München, 81669, Deutschland
The third spring symposium of the DVMD is dedicated to current topics in clinical research. These include big data, ePRO and risk-based monitoring.

Praxis-Workshop: Market authorization of medical devices
2020-03-18 - 2020-03-19 | Hotel NH Düsseldorf City Nord, Münsterstraße 230/238, Düsseldorf, 40470, Deutschland
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.
On 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.
The 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.

Hot topics

Innovations in the current medical device regulation

Legal basis

The CE marking process using a concrete example

Creation of a technical documentation

Structure and processes of a quality management system

Clinical evaluation process

Program .pdf please download here >>

DGPharmMed Annual Meeting
2020-03-12 - 2020-03-13 | Ellington Hotel Berlin, Nürnberger Str. 50-55, Berlin, 10789
Visit us for two days with 7 symposia, round table discussions and stimulating exchange with colleagues from various disciplines.

Good Clinical Study Design
2020-02-20 | Hotel Stadtpalais, Deutz-Kalker-Str. 52, Köln, 50679, Deutschland
Dr. Michael Obermeier, Head of Biostatistics at GKM, lectures at the FORUM seminar “Good Clinical Study Design”.
The 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.

What is the authority’s focus when assessing the design?
How do you proceed methodically on the planning timeline?
Which statistical considerations play a role?
And how is the project assessed from an ethical perspective and in terms of patient safety?

This seminar focuses on innovative and complex study designs such as adaptive, basket and umbrella, which are becoming increasingly important for clinical trials.
Read more: https://www.forum-institut.de/seminar/2002242-good-clinical-study-design

Compact seminar: Clinical Evaluation and Clinical Investigations of Medical Devices in Munich
2019-12-04 - 2019-12-06 | TÜV SÜD Akademie GmbH, Training Center München, Westendstraße 160, 3. Stock, München, 80339
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”.
The event will be in German, only.

27. BVMA-Symposium
2019-11-29 | Sheraton München, Arabellapark Hotel, Arabellastr. 5, München, 81925
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”.
Other topics are:

Regulatory aspectes from EU and ICH / GCP, the BMG as well as regarding the new medical device regulation
Innovative technologies: patient apps, eDiaries, software as a medical device
Good Practices from the point of view of the BfArM and regarding the multiple participation of subjects in Phase I studies

We look forward to meeting you at the symposium or at the “Get-together” the evening before in the event hotel!
https://www.bvma.de/aktuelles-bvma-symposium/anmeldung-symposium/

Practical workshop: Registration of Medical Devices in Frankfurt
2019-11-28 - 2019-11-29 | Relaxa Hotel Frankfurt, Lurgiallee 2, Frankfurt am Main, 60439
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”
The event will be in German, only.

Training „Clinical Studies for Medical Devices – Qualification for study lead according to Medical Devices Act“ in Munich
2019-11-21 - 2019-11-22 | P.E.G.- DIE AKADEMIE, Kreillerstr. 24, München, 81673, Germany
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”.
The event will be in German, only.
