Presenter: Dr Dennis Jenke (Principal Consultant Nelson Labs Europe)
The collection, interpretation and utilization of extractables or leachables (E&L) data are not trivial processes and the scientific and practical requirements for performing these activities may be beyond the technical and/or resource capacities of many organizations. As Extractables and/or Leachables assessments can be extensive and expensive, a high level of diligence must be exercised in identifying, qualifying and utilizing a CRO to perform E&L studies. Thus, identifying, screening, qualifying and implementing the right CRO is an intentional, thoughtful and meticulous process that requires an investment on both the part of the client and the prospective supplier. In this presentation we will consider some of the technical and practical considerations that will ensure that a good and proper match is made between client requirements and expectations and the CRO’s ability to meet those obligations.