Risk Management Principles for Devices and Pharmaceuticals
iv
Chapter 11 Clinical Evaluation Reports.............................................................................................165
Leo Hovestadt, MSc
Chapter 12 EU Postauthorization Safety Studies, US Postmarket Requirement, and US
Postmarket Commitment. ...............................................................................................181
Tara Isherwood, MSc, BSc (Hons) and Mark Heinemann, BSc
Chapter 13 Minimizing and Monitoring Safety ................................................................................199
Karin de Haart, MSc, Nadja Merkusheva, MD, Bernadette Dwan, BSc, Mpharm, MPSI,
Lisette Hoogendoorn, PhD, and Priscilla Velentgas, PhD
Chapter 14 Use of Pregnancy Exposure Registries and Outcomes Studies for Risk Management. ...213
Jessica D. Albano, PhD, MPH, Angie Graves, MBA, MLS(ASCP), Sara Ephross, PhD,
Brian Buysse, PhD and Tara Isherwood, MSc
Chapter 15 Clinical Evidence and Acceptable Benefit–Risk Evaluation. ...........................................225
Leo Hovestadt, MSc
Chapter 16 Benefit-Risk Assessment: Art or Science?. ......................................................................239
Mariette Boerstoel-Streefland, MD, MSc, MBA
Chapter 17 Risk Management in the Future: Expanding the Use of Electronic Health Records
in Drug Development......................................................................................................249
Tjeerd-Pieter van Staa, MD, MSc, MA, PhD
SECTION III: Case Studies in Risk Assessment and Management. ...........................................257
Chapter 18 Postmarket Pharmacoepidemology Database Study Development to Evaluate
Long-Term Drug Safety—An Example, Prolia. ..............................................................259
Fei Xue, MD, MSC, ScD
Chapter 19 EHR Use for Stimulated Reporting of Adverse Drug Events. ........................................269
Angela Walker, MD and Richard Loomis, MD
Chapter 20 RM During Peri-Approval Process: A Case Study of Actonel. .......................................283
Bruce R. DeMark, PhD
SECTION IV: Risk Communication, Dissemination, and Implementation. ...............................307
Chapter 21 Social Science Theory as a Framework for Designing and Evaluating Pharmaceutical Risk
Management Dissemination and Implementation Strategies. .........................................309
Elaine H. Morrato, DrPH, MPH, CPH
Chapter 22 Using Mixed Methods to Evaluate Therapeutic Risk Minimization Programs: An
Introduction and Case Study. ..........................................................................................333
Meredith Y. Smith, PhD, MPA, FISPE
iv
Chapter 11 Clinical Evaluation Reports.............................................................................................165
Leo Hovestadt, MSc
Chapter 12 EU Postauthorization Safety Studies, US Postmarket Requirement, and US
Postmarket Commitment. ...............................................................................................181
Tara Isherwood, MSc, BSc (Hons) and Mark Heinemann, BSc
Chapter 13 Minimizing and Monitoring Safety ................................................................................199
Karin de Haart, MSc, Nadja Merkusheva, MD, Bernadette Dwan, BSc, Mpharm, MPSI,
Lisette Hoogendoorn, PhD, and Priscilla Velentgas, PhD
Chapter 14 Use of Pregnancy Exposure Registries and Outcomes Studies for Risk Management. ...213
Jessica D. Albano, PhD, MPH, Angie Graves, MBA, MLS(ASCP), Sara Ephross, PhD,
Brian Buysse, PhD and Tara Isherwood, MSc
Chapter 15 Clinical Evidence and Acceptable Benefit–Risk Evaluation. ...........................................225
Leo Hovestadt, MSc
Chapter 16 Benefit-Risk Assessment: Art or Science?. ......................................................................239
Mariette Boerstoel-Streefland, MD, MSc, MBA
Chapter 17 Risk Management in the Future: Expanding the Use of Electronic Health Records
in Drug Development......................................................................................................249
Tjeerd-Pieter van Staa, MD, MSc, MA, PhD
SECTION III: Case Studies in Risk Assessment and Management. ...........................................257
Chapter 18 Postmarket Pharmacoepidemology Database Study Development to Evaluate
Long-Term Drug Safety—An Example, Prolia. ..............................................................259
Fei Xue, MD, MSC, ScD
Chapter 19 EHR Use for Stimulated Reporting of Adverse Drug Events. ........................................269
Angela Walker, MD and Richard Loomis, MD
Chapter 20 RM During Peri-Approval Process: A Case Study of Actonel. .......................................283
Bruce R. DeMark, PhD
SECTION IV: Risk Communication, Dissemination, and Implementation. ...............................307
Chapter 21 Social Science Theory as a Framework for Designing and Evaluating Pharmaceutical Risk
Management Dissemination and Implementation Strategies. .........................................309
Elaine H. Morrato, DrPH, MPH, CPH
Chapter 22 Using Mixed Methods to Evaluate Therapeutic Risk Minimization Programs: An
Introduction and Case Study. ..........................................................................................333
Meredith Y. Smith, PhD, MPA, FISPE