and audio-visual material Training will be delivered in one and it is expected that similar of two ways: materials will be 1. Internet-based implemented for the Peyronie’s indication. 2. Peer-to-peer meetings Training will be linked to a Prescriber Certification Program described in Clinical Study Report Question 11. Comprehensive details of each element of the education and training program and certification material are under construction and will be provided as appendices to the amended ASA. As for the Dupuytren’s The running of the Peyronie’s This is acceptable contracture indication the disease training program will from an RMP sponsor should confirm that closely follow the model already perspective. prescriber certification implemented in Australia for related to the educational Dupuytren's contracture but program will be will be modified so as to be implemented. Details of the specific for Peyronie’s disease. It certification process should will be designed to be included in the ASA. comprehensively educate and train all appropriate users of the product. The sponsor confirms that the Prescriber Certification Program will be related to the education and training program specific for Peyronie's Disease. Prescribers will be Certified they have undertaken either a peer-to-peer training session or satisfactorily completed the Web-based training program. Details of the certification process are included in the amended ASA Module 1.8.2 Risk Management Plan for Australia. The sponsor should confirm Actelion confirms that the This is acceptable that the Peyronie’s Disease Peyronie’s Disease indication in from an RMP indication in Australia will be Australia will be subject to a perspective. subject to a controlled controlled distribution system distribution system as for the as for the same set up for the Dupuytren’s indication. This Dupuytren’s indication. would be consistent with the Details of the controlled current use of CCH in distribution system are included Australia as well as the Risk in the amended ASA, Module Evaluation and Mitigation 1.8.2 Risk Management Plan for Strategies (REMS) in the US. Australia. Details of the controlled
and audio-visual material and it is expected that similar materials will be implemented for the Peyronie’s indication. Training will be delivered in one of two ways: 1. Internet-based 2. Peer-to-peer meetings Training will be linked to a Prescriber Certification Program described in Clinical Study Report Question 11. Comprehensive details of each element of the education and training program and certification material are under construction and will be provided as appendices to the amended ASA. As for the Dupuytren’s contracture indication the sponsor should confirm that prescriber certification related to the educational program will be implemented. Details of the certification process should be included in the ASA. The running of the Peyronie’s disease training program will closely follow the model already implemented in Australia for Dupuytren's contracture but will be modified so as to be specific for Peyronie’s disease. It will be designed to comprehensively educate and train all appropriate users of the product. The sponsor confirms that the Prescriber Certification Program will be related to the education and training program specific for Peyronie's Disease. Prescribers will be Certified they have undertaken either a peer-to-peer training session or satisfactorily completed the Web-based training program. Details of the certification process are included in the amended ASA Module 1.8.2 Risk Management Plan for Australia. This is acceptable from an RMP perspective. The sponsor should confirm that the Peyronie’s Disease indication in Australia will be subject to a controlled distribution system as for the Dupuytren’s indication. This would be consistent with the current use of CCH in Australia as well as the Risk Evaluation and Mitigation Strategies (REMS) in the US. Details of the controlled Actelion confirms that the Peyronie’s Disease indication in Australia will be subject to a controlled distribution system as for the same set up for the Dupuytren’s indication. Details of the controlled distribution system are included in the amended ASA, Module 1.8.2 Risk Management Plan for Australia. This is acceptable from an RMP perspective.