supporting the safe and efficacious use of good Belkyra in the treatment of submental understanding fullness associated with submental fat. The of the relevant training materials will reinforce training anatomy. only in the labelled indication and specify So-called that safe and effective use has not been cosmetic established outside of the submentum. physicians or HCPs will understand who the appropriate other medical Belkyra patient is, how to evaluate and practitioners define the treatment area, and how to safely without inject the product. HCPs will learn formal strategies to manage patient expectations evidence of and comfort during and following sufficient treatment with Belkyra to support familiarity adherence to and achievement of desired with head and aesthetic goals. neck anatomy The sponsor believes that this training should not be program will be sufficient to ensure that able to only appropriately qualified HCPs will be prescribe or allowed to purchase Belkyra. administer this product, and subsequently should not be supplied with it. The HCP The training program includes the The sponsor’s training indications and contraindications for response has program should Belkyra. Additionally, training includes an been noted. include the overview of the causes of submental The education indications and swelling for which Belkyra is not an materials will appropriate treatment option. be reviewed for Belkyra. again after a Furthermore, final PI is the program available. should include information on assessing causes of submental swelling for which Belkyra is not an appropriate treatment option. A rudimentary A comprehensive training program has As understanding been created for Belkyra. Please see the of the training above responses for a description of the materials is not questionnaire proposed as a measure of considered effectiveness of training materials. Also, sufficient to please see proposed questionnaire that has
supporting the safe and efficacious use of Belkyra in the treatment of submental fullness associated with submental fat. The training materials will reinforce training only in the labelled indication and specify that safe and effective use has not been established outside of the submentum. HCPs will understand who the appropriate Belkyra patient is, how to evaluate and define the treatment area, and how to safely inject the product. HCPs will learn strategies to manage patient expectations and comfort during and following treatment with Belkyra to support adherence to and achievement of desired aesthetic goals. The sponsor believes that this training program will be sufficient to ensure that only appropriately qualified HCPs will be allowed to purchase Belkyra. good understanding of the relevant anatomy. So-called cosmetic physicians or other medical practitioners without formal evidence of sufficient familiarity with head and neck anatomy should not be able to prescribe or administer this product, and subsequently should not be supplied with it. The HCP training program should include the indications and for Belkyra. Furthermore, the program should include information on assessing causes of submental swelling for which Belkyra is not an appropriate treatment option. The training program includes the indications and contraindications for Belkyra. Additionally, training includes an overview of the causes of submental swelling for which Belkyra is not an appropriate treatment option. The sponsor’s response has been noted. The education materials will be reviewed again after a final PI is available. A rudimentary understanding of the training materials is not considered sufficient to A comprehensive training program has been created for Belkyra. Please see the above responses for a description of the questionnaire proposed as a measure of effectiveness of training materials. Also, please see proposed questionnaire that has As
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