GMP-Kurs - Good Manufacturing Practice

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GCP Basic Course for Scientists

09. - 10.09.2021, Online Course

 

This GCP course especially designed for this target group opens new career perspectives in clinical research for graduates and students of life sciences. By attending this course you will receive an approved certified basic qualification as a scientist working in clinical research. With the GCP certificate you prove your entitlement to participate in clinical studies.

 

"Good Clinical Practice is an international ethical and scientific standard for the planning, conduct, documentation and reporting of clinical trials in humans. Compliance with these standards creates public confidence that the rights, safety and well-being of trial subjects are protected in accordance with the Declaration of Helsinki and that the data collected during the clinical trial are credible".

(DFG: Principles and responsibilities in the conduct of clinical studies. www.dfg.de/download/pdf/foerderung/programme/klinische_studien/klinische_studien_grundsaetze_verantwortlichkeiten.pdf)

 

In this intensive seminar you will get an overview of professional fields in clinical research and learn where your expertise is most needed. In 15 teaching units you will learn about:

  • Professional Fields in Clinical Research
  • Biometrics in Clinical Trials
  • Medical Writing in Clinical Research 
  • Handling of Investigational Products
  • Data Management
  • Methodical basics
  • Ethical foundation
  • Performance of clinical trials, tasks and duties according to ICH-GCP, AMG, MPG, GCP-V
  • Collateral in the clinical trial
  • Quality assurance in clinical trials

 

All contents are taught and consolidated through practical exercises.

The course has been submitted to the State Medical Association for CME certification.

   


Your GCP package includes:

  • Digital course script
  • Assessment of training success
  • Certificate by educational provider

 

After successful examination you receive your GCP certificate by post.

Validity of GCP certificate: 2 years

Course duration: 2 days, 09.00 – 16.30 daily

Examination on Sunday, 12.09.2021, 11.00 - 12.00 a.m.


Validation of GCP course:

  • Accreditation by German Medical Chamber
  • CME - Certification
  • Registration as ICH E6 Training

 


Participation in the course is eligible for the „Bildungsprämie“. Thus, there is the possibility to receive up to 50% of the course fees as a subsidy.

Further information can be found on the homepage of the education bonus:

https://www.bildungspraemie.info/


Participation fees

Companies: 599 Euro (499 Euro participation until 09.08.2021)
Authorities / University / Privat persons: 349 Euro (279 Euro participation until 09.08.2021)
enrolled (doctoral) students: 299 Euro (249 Euro participation until 09.08.2021)

 

Your contact person:

Steffen Biernath

Phone: 0151-64539781

Mail: Steffen.Biernath@gmp-kurs.de