Foundational ICH-Good Clinical Practice (GCP) E6 (R2) Training

Tijdsduur
Startdatum en plaats
Logo van European Centre for Clinical Research Training

Tip: meer info over het programma, startdatum, prijs, en inschrijven? Download de brochure!

Startdata en plaatsen

Brussels
3 sep. 2019
Brussels
10 dec. 2019

Beschrijving

ICH GCP Training

Course Description

You are a professional within clinical research; investigator, monitor or other staff; then you need to comply with the Good Clinical Practice guideline. This one-day course will give you the needed ICH-GCP training, required by the majority of European Regulators. 

This course has been reviewed by the Belgian GCP Inspectorate.

Our ICH-GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by “TransCelerate BioPharma” as necessary to enable mutual recognition of GCP training among trial sponsors.

This ICH-GCP training is equally recognised by the Swiss Association of Ethics Committees for clini-cal trials as …

Lees de volledige beschrijving

Veelgestelde vragen

Heb je een vraag? Onze adviseurs helpen je graag. Stuur een e-mail naar help+flanders@springest.be

Nog niet gevonden wat je zocht? Bekijk deze onderwerpen: ISTQB, Software Testing, Testen (software), CompTIA A+ / Network+ / Security+ en Mediaplanning.

ICH GCP Training

Course Description

You are a professional within clinical research; investigator, monitor or other staff; then you need to comply with the Good Clinical Practice guideline. This one-day course will give you the needed ICH-GCP training, required by the majority of European Regulators. 

This course has been reviewed by the Belgian GCP Inspectorate.

Our ICH-GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by “TransCelerate BioPharma” as necessary to enable mutual recognition of GCP training among trial sponsors.

This ICH-GCP training is equally recognised by the Swiss Association of Ethics Committees for clini-cal trials as training for investigators and sub-investigators of clinical trials in Switzerland.

Learning objectives

  • Fully grasp the GCP requirements for conduct and documentation of clinical studies
  • Distinguish the responsibilities of all involved parties
  • Understand the regulatory requirements imposed by GCP
  • Recognise common problems and obtain insight to avoid errors

Competencies

This course covers competencies that are part of the ECCRT Competency Framework:

  • Ethical & Participants Safety Considerations (3)
  • Investigational Product Development and Regulation (3)
  • Clinical Studies Operations (GCPs or ISO 14155) (8)
  • Study and Site Management (2)
  • Data Management and Informatics (5)
  • Leadership and Professionalism (1)

Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained.

Programme highlights

  • Clinical Research and Regulations
  • ICH-GCP definitions and Principles
  • ICH-GCP Responsibilities of Ethics Committees/ Investigators/ Sponsors/Monitors
  • The Protocol, Investigator’s Brochure and other Essential Trial Documents
  • The GCP-Addendum of 2016
  • Common GCP non-compliance

Workshops

• GCP Game
• GCP Quiz

Who should attend:

Everyone who wants to understand the current regulations and GCP in clinical studies.
No prior training or working experience in a GCP environment is required

*Due to unforeseen circumstances, the programme may change and the ECCRT reserves the right to alter the venue or cancel the event.

Trainer: Marleen Verbeeck, PhD 

Language: English

Blijf op de hoogte van nieuwe ervaringen

Er zijn nog geen ervaringen.

Deel je ervaring

Heb je ervaring met deze cursus? Deel je ervaring en help anderen kiezen. Als dank voor de moeite doneert Springest € 1,- aan Stichting Edukans.

Heb je een vraag? Onze adviseurs helpen je graag. Stuur een e-mail naar help+flanders@springest.be

Vraag nu gratis en vrijblijvend informatie aan:

Aanhef
(optioneel)
(optioneel)
(optioneel)
(optioneel)
(optioneel)
(optioneel)
(optioneel)
(optioneel)
We slaan je gegevens op, en delen ze met European Centre for Clinical Research Training, om je via e-mail en evt. telefoon verder te helpen. Meer info vind je in ons privacybeleid.