AML ICH GCP Training for investigational site staff

products-servicesAML Clinical Services bvba
January 21st 2015

Overview

In its continuous strive to improve its services, AML has adapted its ICH E6 GCP training for Investigators and Site Staff to harmonize with the criteria set out by TransCelerate. One of the initiatives of the TransCelerate alliance has been to develop a syllabus and learning objectives for an International conference on Harmonization (ICH) registered Good Clinical Practice (GCP) training qualification for investigational and site staff that can be internationally recognized.

AML is now registered and is being added as a recognized Training Provider to the TransCelerate website: http://www.transceleratebiopharmainc.com/external-training-provider-attestation/

Course details

The course is a comprehensive guide to the basic principles of ICH Good Clinical Practice aimed at investigators and site personnel who are active in clinical research. It reviews and demonstrates the principles of GCP and 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 course is provided as a 60-minute module in different training options:

  • Web-based Interactive on-line training sessions:

AML organizes interactive training via web access. Session dates are published on the AML website. Interested parties can register by sending an email to: [email protected]

Companies, hospitals, study groups, etc. with groups of trainees can order AML web-based training for the whole group. The price structure reflects the size of participant group.

  • Face to Face

AML can provide F2F GCP training for companies and institutions on request. Prices can be negotiated depending on number of participants. Training can be adapted to specific groups needs upon request. This training can be hosted in-company or provided at investigator meetings at the moment of study start up. It can also be hosted at AML premises.

Certificate of completion is provided after completion of training. This provides investigational site staff that performs AML’s ICH GCP with assurance that they will not need to undergo needless duplicate training when participating in clinical trials sponsored by a TransCelerate member.

Other training:

Furthermore AML would like to share its expertise on several topics. The set-up of these training is similar as the above training (web-based trainings or F2F upon request). The cost is depending on the duration of the training and is posted on the website. Registration can be done via email at: [email protected]

AML training courses include:

  • Regulatory submissions of clinical trials with medicinal products in Belgium
  • Regulatory submissions of clinical trials with medicinal products in The Netherlands
  • Regulatory submissions of clinical investigations with devices in Belgium
  • Regulatory submissions of clinical investigations with devices in The Netherlands

Benefits

AML Training has several key benefits:

Interactive: Unlike on-line training, classroom courses are interactive: participants can ask questions and seek individual clarifications.

Expert: Training provided by practicing experts, who are themselves performing regulatory submissions: Trainer can share real life examples, case studies and up-to-date insights on current regulations and practices.

Resources

Click on AML ICH GCP Training for other information.
Click on AML to contact the company directly.


Supplier Information
Supplier: AML Clinical Services
Address: Tempelzicht 8, 3210 Linden, Belgium
Tel: +32 (0)16 78 21 70
Fax: +32 (0)16 78 86 72
Website: www.aml-research.com