Nowadays patients suffering from serious or life-threatening illnesses have greater awareness about novel treatments.
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Regulators are increasingly scrutinizing early access to medicines and considering, as is the case in the draft 21st Century Cures Act in the US, mandating pharmaceutical companies to make their access policies public. A number of high-profile patient-driven media campaigns calling on pharmaceutical companies to open up access ahead of commercial approval further highlights the criticality of having a sound early access policy in place.
Our strategy and policy development service leverages Clinigen Group’s extensive experience in the early stages of drug development to help pharmaceutical companies create policies, processes, and strategies that ensure a clear corporate position on early patient access to medicines (internally and externally). This includes things such as:
- Developing a process to ensure continuity of treatment for patients exiting a clinical trial
- Providing patients with ethical, compliant, and fair access to treatments not yet commercially available
- Ensuring consistency in allowing patient access across different countries
- Mitigating risks from potential legal or PR issues
- Future-proofing your organization from constant changes in the regulatory and political environment and from changing stakeholder preferences and expectations
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