Training Courses

SSS has been following the changes in the regulatory environment over the last number of decades and passes on its knowledge in training courses in GCP/AMG and MPG/MDR. We keep pace with the latest regulatory requirements and make this knowledge available to our customers and clinical study teams. In the context of medicinal drug and medical device studies German ethic committees request the evidence of qualification for principle investigators and all medicalphysicians in a study team working in clinical trials. In early 2019 the Bundesärztekammer has published a new recommendation (DOI: 10.3238/arztbl.2019.Empfehlungen_AMG_MPG_2019) for the ethics committees that depending on the previously acquired experience defines the courses which are needed for investigators. A graphical view is given in the figure on the right.
As a profound basis in conducting clinical trials according to GCP guidelines we offer the courses bellow to anyone working in clinical trials (Study Nurses, Study Coordinators, Clinical Research Associates etc.).

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GCP/AMG-Grundlagenkurs

The GCP/AMG-Grundlagenkurs for all physicians in a study team provides fundamental knowledge on the current legal/regulatory aspects and all necessary skills for the conduct of a clinical study.

Upcoming dates (Fridays from 10.00 am to 6.00 pm):

• September 12, 2019 – München
• October 11, 2019 – München
• October 18, 2019 – Frankfurt
• November 15, 2019 – Mainz
• December 05, 2019 – München

Please note: The deadline for registration is two weeks in advance of the training date.

Please note exception for NRW: Deadline for registration is six weeks in advance of the training date.

The GCP/AMG-Grundlagenkurs can be booked individually. It can also be combined in a two day course together with the GCP/AMG-Aufbaukurs.

GCP/AMG-Aufbaukurs

Whereas for all physicians in a study team the one-day GCP/AMG-Grundlagenkurs is sufficient, investigators leading a team (principle investigators and deputies) have to complete an additional one-day GCP/AMG-Aufbaukurs. Upcoming dates (Fridays from 10.00 am to 6.00 pm):

• August 31, 2019 – Stuttgart
• September 13, 2019 – München
• October 12, 2019 – München
• October 19, 2019 – Frankfurt
• November 16, 2019 – Mainz
• December 06, 2019 – München

Please note: The deadline for registration is two weeks in advance of the training date. Detailed information about the course you find in our brochure GCP/AMG-Aufbaukurs .

Please note exception for NRW: Deadline for registration is six weeks in advance of the training date.

The GCP/AMG-Aufbaukurs can be booked individually. It can also be combined in a two day course together with the GCP/AMG-Grundlagenkurs.

GCP/AMG-Auffrischungskurs

Most ethics committees request a successfully completed GCP/AMG-Auffrischungskurs every three years for principle investigators, co-investigatory and all physicians in a study team.
Upcoming dates (Fridays from 1.00 pm to 6.00 pm):

• September 20, 2019 – München
• December 13, 2019 – München

Please note: The deadline for registration is two weeks in advance of the training date. Detailed information about the refresher course you find in our brochure GCP/AMG-Auffrischungskurs .

MPG/MDR-Ergänzungskurs

The course is designed as a supplementary course for experienced principle investigators, co-investigators and all physicians in a study team with either a valid GCP/AMG-Grundlagenkurs or GCP/AMG-Aufbaukurs certificate. This course provides the opportunity of updating important knowledge about conducting clinical investigations for medical devices. It offers knowledge about legal regulations and requirements which shall apply for conducting clinical investigations. This supplementary course is demanded by the ethics committees for the acceptance as investigators in clinical investigations in accordance with MPG/MDR.
Upcoming dates (Friday 1.00 pm – 6.00 pm)

• December 20, 2019 – München

Deadline for registration is two weeks before the beginning of the training. Detailed information about the course you find in our brochure MPG/MDR-Ergänzungskurs .

There is no suitable date? For groups we also organize trainings at individual dates at our or your office. If you have questions regarding the courses required for you to participate in clinical trials please contact us at: +49 89 800 650 0 or fill in the contact form with your inquiry.

© 2019 SSS International Clinical Research