Training & Coaching

Training & Coaching aspects of IMP management consulting we cover:
  • Dedicated in-house seminars both, on operational and regulatory topics
  • Operational topics
    • Translation of a clinical protocol into an appropriate packaging design
    • Efficient use of standard software tools to support the IMP preparation
    • Pragmatic and efficient management of big global clinical studies
    • Use of IVRS/IWRS systems
    • Interface management / improved communication between clinical and pharmaceutical development - get clinicians involved as ‘customers’
    • Sourcing decision: internal or external
    • Contractors: selection, auditing, contracts and management
  • Regulatory topics
    • Up to date GxP training on all current regulatory requirements for IMP management
    • Best practice in work and material flow
    • Specific needs for blinding and over-encapsulation
    • Needs for labelling IMPs for international trials
    • Needs for importing / exporting IMPs
Project References