Early dialogue with health technology assessment bodies: a European perspective.

Introduction: Evidence requirements may differ across HTA bodies, and so pharmaceutical companies must plan to synergize their evidence generation strategy, across global regulatory and HTA bodies. Until recently, companies had no official platform to discuss the clinical development of a drug with HTA bodies; however, this is changing.

Objectives: To achieve broad usage in the EU, products must achieve both regulatory and reimbursement approval, the latter of which is based on HTA appraisal in many markets.

The excimer laser-assisted nonocclusive anastomosis practice model: development and application of a tool for practicing microvascular anastomosis techniques.

Objective: To practice microsurgical skills, several experimental models are available that diminish the need for experimental animals. We defined criteria with which such models should comply, and we tested whether the models described in literature, as well as our own practice model, comply with these criteria.

Methods: We defined the criteria to which these models should comply, and we performed a literature search on microvascular practice models.