Training Courses

Having started out as an auditing service company, SSS International Research has a solid regulatory background including the relevant provisions of the German Medicinal Products Act (Arzneimittelgesetz – AMG), German Medical Devices Act (Medizinproduktegesetz – MPG) and the UK Clinical Trials Regulations. SSS has been following the changes in the regulatory environment. over the past number of decades and passes on it knowledge in training courses – GCP/AMG and for MPG/MDR . We keep pace with the latest regulatory requirements and make this knowledge available to our customers and clinical study teams.

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Refresher GCP/AMG (for Germany only)

GCP/AMG Refresher Course

About the course

The course, based on the current recommendations of the "Arbeitskreis Medizinischer Ethik-Kommissionen’ (the working group of medical ethics committees in Germany), gives experienced study team members the opportunity to update their clinical trial skills and refresh their knowledge of the legal regulations and requirements which apply to the conduct of clinical trials. Investigators require regular training courses in ICH/GCP and legal provisions as a proof of qualification.

Who should participate?

  • Investigators (hospitals, pharmaceutical companies, and research institutes)
  • Study nurses
  • Clinical trial support staff (e.g. staff working in CROs or at sponsors)

Course topics

  • Legal foundations (currently applicable legal situation [AMG/GCP Ordinance, EU Regulation 536/2014, 4th Law Amending Pharmaceutical and Other Regulations, Addendum to ICH-GCP)
  • ICH-GCP Roles & Responsibilities
  • Patient Safety & Adverse Events
  • Informed Consent
  • Documentation

Certification

Successful completers of the GCP refresher course are awarded a certificate indicating the course timing and content as required according to ethics committee guidelines. An application to the Bavarian Medical Association (Landesärztekammer Bayern) has to be filed to obtain recognition of the training, which earns six education credit points (Fortbildungspunkte). Upcoming dates (Fridays from 1.00 pm to 6.00 pm):

  • December 07, 2018
  • March 15, 2019
  • June 14, 2019
  • September 13, 2019
  • December 13, 2019
    Participation fee: EUR 325.00 + 19% MWSt = VAT (including training material and snacks)

Venue

SSS International Clinical Research GmbH
Landsberger Straße 23/25
82110 Germering
Germany
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MPG/ MDR Supplementary Course

About the course

The course is designed as a supplementary course for experienced study team members with a valid GCP certificate based on the current recommendations of the ‚Arbeitskreis Medizinischer Ethik-Kommissionen‘ providing experienced study team members the opportunity of updating important knowledge about conducting clinical trials for medical devices. It offers knowledge about legal regulations and requirements which shall apply for conducting clinical trials. For investigators as a proof of qualification supplementary courses in MPG and MDR are required.
Who should take the course?

  • Investigators (hospitals, biotech companies, and research institutes)
  • Study Nurses
  • Clinical Trial support staff (e.g. staff working in CRO)

Course Topics

  • Legal bases (current valid legal situation (MPG/MDR)
  • Roles & Responsibilities
  • Participant Safety & Adverse Events
  • Informed Consent
  • Documentation

Certification

Upon successful completion of the course according to the guidelines of ethic committees participants receive a certificate. The medical association of Bavaria certifies the course. Upcoming dates (Friday 1.00 pm – 6.00 pm)
March 22, 2019 June 21, 2019 September 20, 2019
December 20, 2019

There is no suitable date? Then we would like to visit you for the course.
Participation Fee: 325,00 EUR + 19% MwSt. (incl. training material)

Venue

SSS International Clinical Research GmbH
Lndsberger Straße 23/25
82110 Germering

For more information call us at: +49 89 800 650 0

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