Provide the proposed educational A general outline of the proposed CME program was provided in The sponsor has not provided a copy of the draft materials to the Office of Product the Sponsor’s response. educational materials with their response or Review (OPR) prior to marketing and details on the knowledge and training those who additional detail on how they will be will deliver the programs. implemented. That is, which If this submission is approved it is recommended representatives from the sponsor will the sponsor provide within 6 months of deliver face to face activities and how registration will the sponsor ensure they have the - copies of the educational materials appropriate training/knowledge. In - how these will be implemented and the training addition, confirm if the outcomes of and knowledge of the presenters the evaluation of educational activities - the intended duration of this program will be provided to the OPR via Period Safety Update Reports or another mechanism. It was recommended to the Delegate that The study report for study 1218.63 was completed in December This was considered acceptable. the sponsor: 2011, with revisions in February 2012. The complete study report Provide an update on the progress of the was provided in the ongoing extension of indications application study report for study 1218.63. The for Trajenta (linagliptin) [submission ID: PM-2012-01168-3-5]. sponsor states that the estimated/actual completion date for study 1218.63 was November 2011.
Provide the proposed educational materials to the Office of Product Review (OPR) prior to marketing and additional detail on how they will be implemented. That is, which representatives from the sponsor will deliver face to face activities and how will the sponsor ensure they have the appropriate training/knowledge. In addition, confirm if the outcomes of the evaluation of educational activities will be provided to the OPR via Period Safety Update Reports or another mechanism. A general outline of the proposed CME program was provided in the Sponsor’s response. The sponsor has not provided a copy of the draft educational materials with their response or details on the knowledge and training those who will deliver the programs. If this submission is approved it is recommended the sponsor provide within 6 months of registration - copies of the educational materials - how these will be implemented and the training and knowledge of the presenters - the intended duration of this program It was recommended to the Delegate that the sponsor: Provide an update on the progress of the study report for study 1218.63. The sponsor states that the estimated/actual completion date for study 1218.63 was November 2011. The study report for study 1218.63 was completed in December 2011, with revisions in February 2012. The complete study report was provided in the ongoing extension of indications application for Trajenta (linagliptin) [submission ID: PM-2012-01168-3-5]. This was considered acceptable.