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.

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.

Course outline:

1. Clinical Supply Chain and Project Management
   

   • Overview drug development process & clinical supply chain

   • Improvement of site – and patient compliance

   • Project management approaches – activities, responsibilities, timelines

    

2. International IMP Regulations – Overview

• IMP international regulatory framework

• Key documents: Dir.2001-20EC; Dir.2001-83EC; Dir.2003-94EC; Annex 13 and Annex 16; 21CFR210+211

• QP release process

 

3. IMP Planning and Supply Management

• Review Clinical study protocol / Synopsis

• Roles and Responsibilities of involved parties

• Transfer study design => packaging design

• Planning and definition of milestones

• Pro-active supply management

 

4. GMP - Bulk Product Manufacturing

• Demand planning: calculations of quantities and timelines

• Blinding techniques

• Test and Placebo product: formulation, manufacturing, stability and release

• Comparator product: evaluation and availability, sourcing, manufacturing, stability and release

 

5. GMP – Packaging

• Selection pack materials

• Packaging technologies (e.g. multi drug blisters, child resistant packs)

• Packaging process in compliance with Annex 13

• Documentation; Analytical ID- and retain samples

6. GMP – Labeling

• Annex 13 labeling requirements § 26 - 33

• Label text definition and translation process

• Label types - Multilingual Labeling - Labeling process

• Re-labeling process for extension of shelf life

 

7. GDP - Storage and Distribution

• GDP – Good Storage Practice

• Warehouse and courier qualification

• Set-up of trial logistic concepts for multi-national, multi-center trials – lessons learned, pitfalls

• Distribution strategies for multi-national trials

• Specialties: cool chain products, controlled drugs, systems to use

 

8. GMP / GCP Interfaces

• Critical interactions between clinical development and pharmaceutical development (IMP preparation: - planning, blinding, packaging design, IRT design, etc.)

• Clarifying and fixing responsibilities at the interface

• Anticipating distribution problems; Relabeling – when, where and by whom

• IMP product accountability, reconciliation and destruction

• Cooperation in Set-up of IRTs

 

9. Interactive Response Technologies (IRT)

• Introduction of basic IRT functionalities: how and when to use

  Interfaces to other e-clinical systems (e.g. EDC, eCRF,
  e-diary)

• Selection criteria for projects and vendors

• How to approach and conduct an IRT project from
  URS to UAT

• Lessons learned from a sponsor and vendor perspective

 

10. Outsourcing Strategies and Vendor Management

• Outsourcing: Reasons and policies; strategic approach or as trouble shooting?

• Regulatory framework for the outsourcing cooperation

• Selection criteria for projects and contractors

• Sponsor - vendor relationship, establishment of real vendor management

• Lessons learned from the sponsor and the vendor perspective

Course facts

Do you want our newsletter?

» Make sure to get the latest information

» Tip a colleague