Online Training Courses for Performing Clinical Trials

 

Good Clinical Practice for medicinal products and ISO14555
Good Clinical Practice for medical devices and all applicalbe EU directives

The law requires an appropriate qualification for the acceptance of responsibility in clinical trials. These can be acquired in a two-day class lecture, which is usually associated with down time and also with travel expenses. An online training for medical and non-medical staff provides the training at work or at home.


Training courses according to

  • EU Directive 2001/20/EC
  • ICH-GCP guideline for good clinical practice
  • ISO 14155 (2011) Clinical investigation of medical devices for human subjects - good clinical practice
  • Ethics committees’ demands

 

Topics

GCP/ISO 14155

Phases of clinical trials during drug development in humans
Legal requirements
International Conference on Harmonization (ICH)
Declaration of Helsinki
Guidelines of Good Clinical Practice (GCP)
Investigator’s responsibilities
Documentation/ Investigator file
Adverse Events (AE/SAE)
Pharmacovigilance
Reporting and quality improvement
Quality assurance
Audits/site inspections

 

Modular Concept

GCP course

GCP/ISO 14155 course

7 modules 9 modules
9 tests approx. 10 to 12 hours 10 tests approx. 10 to 15 hours

Learning method

  • 3 to 5 hours video presentations

  • 3 to 4 hours literature basics
  • 2 to 3 hours tests 

 

Bavarian Chamber of Physicians - Certificate

The online courses are - if necessary - certified by the Bavarian Chamber of Physicians with 17-24 CME points.

 

Advantages

  • not travel expenses
  • start at any time
  • quick certification service
  • access remains active after test

 

Trainers

  • Dr. med Jacobo Maldonado, investigator and auditor
  • Marion Alzer, clinical trial associate and translator

Access

www.consamed-academy.com


Fees

Training

 Fees - Tax included

Reduced Fees for Members

GCP training course € 297,50 € 187,00
GCP/ISO 14155 training course € 321,50 € 202,50

plus Certificate € 23,80
For registration members of Forum MedTech Pharma please via Online-Shop. Questions of non-members please via E-Mail.

 

Contact Person

Dr. Ilja Hagen
Forum MedTech Pharma e.V.
Tel.: +49 - 911 - 206 71-334
hagen(a)medtech-pharma.de


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