Post-approval Studies for Rare Disease Treatments and Orphan Drugs

Author:

Maier William C.,Christensen Ronald A.,Anderson Patricia

Publisher

Springer International Publishing

Reference10 articles.

1. Carlson JJ et al (2009) Paying for outcomes: innovative coverage and reimbursement schemes for pharmaceuticals. JMCP 15(8):683–687

2. EMA Guidance – Good Pharmacovigilance Practices Module V Risk Management Systems 28 April 2014

3. EMA – Good Pharmacovigilance Practices Module VIII Post-Authorization Safety Studies 20 February 2012

4. EMA Guidance – Good Pharmacovigilance Practices Module XVI: Risk Minimization Measures – Selection of Tools and Effectiveness Indicators: 28 April 2014

5. EMA Guidance – Safety and Efficacy Follow-up of Advanced Therapy Medicinal Products – Draft Guidance 2008

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