Customs laboratories in the Member States cooperate via the Group of Custom Laboratories, which is supported by DG Taxation and Customs Union. The JRC provides them with expert advice related to relevant analytical methods and carries out the necessary development if no methods are available (. for the classification of meat according to heat treatment, content of milk fat, discrimination of tobacco varieties). The availability of such methods fosters international trade, helps to resolve disputes and prevents the evasion of customs duties.
This forum considers the place of observational research in the clinical evaluation of medicines and seeks views on how to select promising study designs, prospectively specify objective criteria for evaluation of study results and define procedures to ensure the reliability of results. The overall aim is to contribute to the ongoing debate on how to assess research based on observational studies and in particular, how to pre-specify criteria of ‘success’ in an observational study in a way that would allow confident design of a research programme to meet regulatory requirements. These discussions will address the lack of regulatory guidance in this area, which was highlighted by moves to extend the use of epidemiological analyses (previously used primarily for prospective clinical trials) into areas of medicine development due to the increasing availability of more and higher quality observational data.