SIFI's mission is to improve people's lives through meaningful innovation in eye care. SIFI provides ophthalmologists and their patients with a wide range of therapeutic solutions, including medical devices, nutraceuticals and innovative medicines. In this context SIFI aims todevelop effective and safe new medicines with special attention to rare eye diseaseswhere there is a high unmet medical need. To do this, SIFI conduct clinical trials to assess the safety and effectiveness of investigational medicines, which, if established, will help us obtain approvals from regulatory authorities and make the medicines commercially available for patients.
Early Access Programmes (EAP) may represent a real opportunity of treatment for those patients before the product is ready to be launched. SIFI has adopted the term "EAP", which encompasses investigational medicine access mechanisms in a number of different countries, such as:
- AAC or AP in France
- Expanded Access Programmes (EAP)
- Right to Try in the United States of America
- Compassionate Use programmes (CUP) in Spain and Italy
Requests for access must be made by the treating physician by email at (firstname.lastname@example.org) and should include the following details:
1. Date of the request.
2. Physician's name, contact information, address, country and professional qualifications.
3. Name of the investigational medicine and therapeutic indication, including treatment plan.
4. Medical rationale for the request and reason for exclusion from an existing clinical study, if applicable.
All requests received will be carefully reviewed by the Company EAP Governance committee. SIFI commits to respond to requests within five business days of receipt of the request and required medical documentation.
Further information can be found in the attached policy document.