| Content (1 Day) | |
| 08:30 – 08:45 | Introduction |
| 08:45 – 10:00 | Regulations and GMP/GCP-requirements |
| 10:00 – 10:15 | Coffee Break |
| 10:15 – 10:45 | Primary- and secondary packaging materials |
| 10:45 – 12:00 | General aspects of the manufacturing of Investigational Medicinal Products including labelling and packaging as well as certification/release (Part 1) – with group work |
| 12:00 – 12:45 | Lunch Break |
| 12:45 – 13:45 | Special aspects of the manufacturing of Investigational Medicinal Products (Part 2) |
| 13:45 – 14:30 | Suppliers and vendors: qualification, responsibilities, contracts |
| 14:30 – 14:45 | Coffee Break |
| 14:45 – 15:30 | GMP/GCP documentation, archiving (45 min) Alternatively: Responsibilities of Personnel Please choose! |
| 15:30 – 16:00 | Storage and transport of IMPs |
| 16:00 – 16:30 | Final discussion and open questions |
