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. 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):

  • April 20, 2018
  • June 15, 2018
  • September 14, 2018
    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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