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Evaluation of Drugs for Rare Diseases
RARE - K Neal |
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Download the program here. 1. Differentiate between rare and common diseases, and the barriers and opportunities for developing orphan drugs. 2. Describe the role of patient groups in developing new products for rare diseases. 3. Consider the pathophysiology, pharmacological and therapeutic models for rare diseases. 4. Assess whether the preclinical and clinical development models for non-rare disease therapies could be implemented for treatments in rare diseases. 5. Outline the regulatory, legal, and ethical requirements for rare diseases and orphan drugs. 6. Evaluate the specific scientific, financial and administrative support needed for running clinical trials and obtaining marketing authorization in rare diseases. 7. Consider multicenter, randomized controlled trials for rare diseases. 8. Assess the acceptable level of evidence from non-randomized or uncontrolled trials. 9. Explain and implement methodological aspects and innovative methods from phase I clinical trials to post-marketing studies for rare diseases. 10. Outline pharmacovigilance, pharmacoepidemiology and risk management plans in rare diseases. Go to Elective Modules |
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