Best Practices for Global Investigational Medicinal Product (IMP) Management

Detailed course outline:

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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

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