You want to know where investigational products come from, how they are made and what rules and regulations have to be followed?
You are working with Investigational Medicinal Product (IMP), you already have the knowledge of Good Clinical Practices and now you need to be able to link it to the good manufacturing practices?
Then register for this eLearning course. We cover from raw material until IMP destruction to help you manage IMP properly within your Clinical Trial. Good Manufacturing Practice, Good Clinical Practice and Good Distribution Practice will hold no secrets anymore.
This eLearning course is designed for professionals who are involved in the handling of investigational medicinal products.
Through an interactive approach this eLearning course targets 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, professionals who are in charge of or supervise packaging, randomisation and allocation or labelling of investigational medicinal products will benefit from this course
Optionally you can also 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, ICH GCP E6; 2013/C343/01 (GDP)and 2013/C 68/01 guidelines.
Interactive quizzes and exercises for self-assessment are included to provide a better understanding of each part of the course. You will be able test your comprehension with a final grading assessment. All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.
Course timeAt your own pace; the course wil remain available online for you for 3 months after you register for it.--------------------- Course Credits: 6 hours
Who should attend
- Clinical research professionals involved in packaging and labelling of investigational medicinal products
- A must for study team members or personnel in roles with responsibility for investigational medicinal products
- Beneficial for site team members with knowledge of GMP requirements for clinical trial supplies
- International Standards,
- Introduction to the manufacture, documentation, distribution and processing of investigational medicinal products,
- Packaging and labelling,
- Randomisation and allocation,
- Returns, recall, complaints and destruction management.
- Use of commercial products in EU clinical trials
- Annex 13/EC-GMP Guidelines
Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.
- Review the worldwide requirements regarding Investigational Medicinal Product management,
- Explain steps, roles and responsibilities in the course of IMP manufacturing and processing,
- Make the link between the Good Manufacturing Practices and the Good Clinical Practices,
- Define the quality and documentation required when dealing with Investigational Medicinal Product.
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (8)
- Study and Site Management (1)
- Data Management and Informatics (1)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
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