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Table of Contents |
| Part 1: |
Introduction |
| Part 2: |
Research and Development |
| Part 3: |
Regulatory Requirements in USA & Europe |
| Part 4: |
Clinical Outcomes Research |
| Part 5: |
Therapeutic Device Clinical Outcomes Research
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| Part 6: |
Diagnostic Device Clinical Outcomes Research
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| Part 7: |
Drug-Device Combination Research
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| Part 8: |
Economic Evaluations |
| Part 9: |
Patient-Reported Outcomes Research
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| Part 10: |
Evidence Development and Reimbursement |
EDITORS:
- Stacey J. Ackerman, MSE, PhD,
Vice President,
Covance Market Access Services Inc.,
San Diego, CA
- Marilyn Dix Smith BSPharm, PhD, Executive Director, International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville, NJ, USA
- Jenifer Ehreth MHA, PhD, Principal, International Market Access, Paris, France and Adjunct Professor, University of Lausanne, Health Economic Institute, Lausanne, Switzerland
- Randa Eldessouki MBBCh, MSc, MD, Director, ISPOR Scientific Initiatives, ISPOR, Lawrenceville, NJ, USA; Lecturer, Faculty of Medicine, Fayoum University, Fayoum, Egypt
- Erin Sullivan MPH, PhD, Vice President, Health Economics & Outcomes Research, Avalere Health LLC, Washington DC USA
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