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