Good Manufacturing Practice (GMP) in relation to GCP

 

Good Manufacturing Practice (GMP) in relation to GCP

Clinical Research Related Courses

You want to know where investigational products come from, how there are made and what rules and regulations have to be followed? Then register for this course: we cover from raw material until IMP destruction; Good Manufacturing Practice, Good Clinical Practice and Good Distribution Practice will have no secrets anymore.

dates
location
language
28 Nov 2012 Brussels English
850,00 €
  • Full description & trainer
  • Programme highlights
  • Learning objectives
  • Workshops & extras
Full description

This one day course is designed for professionals who are involved in the handling of investigational medicinal products. The target group for this course includes monitors, project managers, site personnel, or administrative persons who are responsible for sending, storing, accountability, final
disposition, etc of medicinal products used in clinical trials. In addition to persons in the named positions, professionals who are in charge of or supervise packaging, randomisation and allocation or labelling of investigational medicinal products will get an overview of the latest regulatory standards set by the European Union including Directive 2001/20/EC, 2003/94/EC, 2005/28/EC, Annex 13 of EC-GMP Guideline, ICH GMP Q7 and ICH GCP E6 guidelines.

Who should attend?

Clinical research professionals involved in packaging and labelling of investigational medicinal products

CRAs/Monitors

A must for study team members or personnel in roles with responsibility for investigational medicinal products

Beneficial for site team members with insufficient knowledge of GMP requirements for clinical trial supplies

Trainers

Introduction to the manufacture and processing of investigational medicinal products in the EU

Packaging and labelling

Randomisation and allocation

Use of commercial products in EU clinical trials

Annex 13/EC-GMP Guidelines

  • To give a comprehensive overview of the different regulatory references regulating Good Manufacturing Practice (GMP) requirements for investigational medicinal products
  • To explain steps, roles and responsibilities in the course of IMP manufacturing and processing
  • To explain which IMP documents have to be available at the beginning and during a clinical trial