General Comments [information redacted] This response on the Education appears inconsistent program with those provided below and the It is recommended content of the ASA. that the sponsor provide the updated The Sponsor versions of following remains unclear RA materials to the regarding the risk TGA for review prior minimisation plan to approval proposed for [information Australia. redacted] [Information redacted] The evaluation of [information redacted] This response the educational appears inconsistent materials is with those provided discussed in the RA above. EU-RMP Section The Sponsor 4.2.4 and Annex 8. It remains unclear is recommended regarding the risk that the Sponsor minimisation plan consider evaluating proposed for the effectiveness of Australia. these educational [information materials for redacted] The Australian Sponsor should physicians and confirm the risk patients. minimisation plan The sponsor should proposed for give details of the Australia. party “third Due to the potential provider” in for serious adverse Australia as events with mentioned in the certolizumab PsA and AS treatment, in addition to the ongoing safety concerns associated with the product, additional risk minimisation activities, as applied in the EU, are required in Australia. The sponsor states UCB confirms that this training as The Sponsor that on the it occurred in the European Union remains unclear “Training updated materials will also take place Australia regarding their risk and the associated prior to the distribution of the minimisation plan need for new educational material if UCB
General Comments on the Education program It is recommended that the sponsor provide the updated versions of following RA materials to the TGA for review prior to approval [information redacted] [information redacted] This response appears inconsistent with those provided below and the content of the ASA. The Sponsor remains unclear regarding the risk minimisation plan proposed for Australia. [Information redacted] The evaluation of the educational materials is discussed in the RA EU-RMP Section 4.2.4 and Annex 8. It is recommended that the Sponsor consider evaluating the effectiveness of these educational materials for Australian physicians and patients. The sponsor should give details of the “third party provider” in Australia as mentioned in the PsA and AS [information redacted] This response appears inconsistent with those provided above. The Sponsor remains unclear regarding the risk minimisation plan proposed for Australia. [information redacted] The Sponsor should confirm the risk minimisation plan proposed for Australia. Due to the potential for serious adverse events with certolizumab treatment, in addition to the ongoing safety concerns associated with the product, additional risk minimisation activities, as applied in the EU, are required in Australia. The sponsor states that “Training on the updated materials and the associated need for UCB confirms that this training as it occurred in the European Union will also take place Australia prior to the distribution of the new educational material if UCB The Sponsor remains unclear regarding their risk minimisation plan
auspar-certolizumab-140815.docx