Best Practices for Global Investigational Medicinal Product (IMP) Management

Industry field:

Pharmaceutical industry, Final dosage form

Course description:

The preparation of investigational medicinal products (IMPs) plays a key role in the drug development and regulatory process leading to the approval of new drugs and of new indications for existing medicines. Compared to commercial production and packaging operations, there are many critical differences, which serve to identify the IMP preparation as a discipline in its own right with the need for specialist knowledge to cope with its unique problems. As such, there are numerous aspects, professionals working in the IMP preparation process need to be familiar with. The ultimate goals of successful IMP supply are to deliver medication on time with quality on international standards, and thus ensuring best possible site and patient compliance.

This program features in-depth discussions on each aspect of the IMP preparation process, from planning and project management, bulk manufacturing, packaging and labeling, testing and release, storage and distribution through to drug accountability and destruction. We will focus on specific "how to" procedures that represent best practices in all areas of IMP preparation, including application of tools, whilst complying with the unique EU and US GMP and GCP requirements (EU Annex 13 regulations, FDA Guidance and ICH Guidelines). We will also include sessions on outsourcing and vendor management and on the use of Interactive Response Technologies (IRT). Finally, the program will feature two small group sessions which will enhance the practical application of the concepts presented.

Course outline:

1. Clinical Supply Chain and Project Management

2. International IMP Regulations – Overview

3. IMP Planning and Supply Management

4. GMP - Bulk Product Manufacturing

5. GMP – Packaging

6. GMP – Labeling

7. GDP - Storage and Distribution

8. GMP / GCP Interfaces

9. Interactive Response Technologies (IRT)

10. Outsourcing Strategies and Vendor Management

      » Detailed outline

Learning objectives:

Overall objective of this course is to provide attendees with concepts and techniques enabling them to improve cycle times by means of smart project management concepts, use of technology and practical approaches in the frame of global GMP regulations. Attendees will gain practical knowledge in establishing an effective clinical supply chain, enabling IMP preparation in a timely, cost efficient and GMP compliant manner, whilst applying pragmatic approaches. They will learn practical skills to comply with all the basic EU and US GMP requirements for the IMP preparation, to apply best practices, and to set up appropriate outsourcing and vendor management for the IMP preparation and the use of IRT.

Who should attend:

The course is designed for professionals in the pharmaceutical industry who are involved directly in the IMP preparation (manufacturing, packaging, labeling, testing, release, storage and distribution) as well as professionals who are the customers for IMP supply such as clinical science / operations professionals, both, from Sponsors and from Contract Research Organisations. It is also designed for professionals who are responsible for regulatory and quality activities for IMPs.

» Registration

» Download course folder (PDF)

» Registration

» Download course folder (PDF)

Course facts

Do you want our newsletter?

» Make sure to get the latest information

» Tip a colleague