Workshop 3: Contract Manufacture

Drugs preparation requires an adequate number of qualified people and premises adapted. Legal requirements for manufacturing drugs are constantly increasing. To face these exigencies, outsourcing preparations between hospital pharmacies or other manufacturer has developed in recent year. Different preparations as anticancer drugs, parenteral nutritions or other individual or hospital batch preparations can be outsourced.

The objective of this workshop is to discuss the following points:

• Regulatory aspects

• Methodology for the implementation of the outsourcing

• Development of the contract between the Contract Giver and the Contract Acceptor

• Monitoring of outsourcing in particular by carrying out audits

These various elements will be discussed theoretically and enriched the workshop with practical experiences of the participants.