Publications
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Displaying 1 through 21 of 21 publications.
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Midkiff K, Harris D, Gilsenan A, Andrews E. Studying cancer as an adverse outcome from nononcological therapies: review of the Food and Drug Administration's postmarketing commitment database. Poster presented at the 31st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2015. Boston, MA.
Hauber AB, Gilsenan A, Juhaeri J, Zhong Y, Noel B. Benefit risk assessment: understanding and using patient preference methodologies. Presented at the 31st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2015. Boston, MA.
Harris D, Gilsenan A, Harding A, Andrews E, Kellier N, Masica D. Long-term cancer surveillance: five-year update for the Forteo Patient Registry Surveillance Study. Poster presented at the 31st International Conference on Pharmacoepidemiology and Therapeutic Risk Management; August 2015. Boston, MA.
Harris DH, Gilsenan AW, Harding AA, DeGuire B, Andrews EB. Long-term cancer surveillance: five-year update for the Forteo Patient Registry data linkage study. Presented at the NAACCR 2015 Annual Conference; June 2015. Charlotte, NC. Previously presented at the 31st International Conference on Pharmacoepidemiology and Therapeutic Risk Management.
Midkiff KD, Andrews EB, Gilsenan AW, Harris DH. "First in Flight" or "When Pigs Fly" – Can cancer registries play a critical role at the national level in studying cancer as an adverse outcome from drug treatments? Presented at the NAACCR 2015 Annual Conference; June 2015. Charlotte, NC.
Midkiff KD, Gilsenan AW, Andrews EB, Masica D, Ceberg J, Alvegard T. Findings from the postmarketing adult osteosarcoma surveillance study in the Nordic countries. Poster presented at the 37th Meeting of the Scandinavian Sarcoma Group; May 20, 2015. Stockholm, Sweden.
Andrews EB, Gilsenan AW, Midkiff KD, Harris DH. Comments on Bang et al.: the impact of recombinant parathyroid hormone on malignancies and mortality: 7 years of experience based on nationwide Danish registers. Osteoporos Int. 2015 May;26(5):1663-4. doi: 10.1007/s00198-014-3003-z
Kruse-Jarres R, Gilsenan AW, Spears J, Kaye JA. Prospective, observational study of plasma-derived factor VIII/von Willebrand factor in immune tolerance induction: the PRISM registry. Haemophilia. 2015 Mar;21(2):e122-4. doi: 10.1111/hae.12590
Gilsenan AW. European guideline on Good Pharmacovigilance Practices (GVP) – Module XVI – risk minimization measures. Presented at the SCOPE Summit for Clinical Ops Executives; February 25, 2015. Orlando, FL.
Gilsenan AW. Observational data collection studies: considerations to minimize bias. Presented at the SCOPE Summit for Clinical Ops Executives; February 24, 2015. Orlando, FL.
Freeman E, Gilsenan AW. Assess the European guideline on good pharmacovigilance practices (GVP) – module XVI – risk minimization measures. Presented at the 7th Risk Evaluation and Mitigation Strategies Summit (REMS Summit); January 22, 2015. Arlington, VA.
Kellier N, Krohn K, Gilsenan AW, Harris DH, Andrews EB, Massica D. Forteo voluntary patient registry: 3-Year progress on a prospective osteosarcoma surveillance study. Poster presented at the American Society for Bone and Mineral Research Annual Meeting; October 6, 2013.
Gilsenan AW, Midkiff KD, Andrews EB, Von Scheele BG, Masica D, Ceberg J. Multinational collaboration: a long-term surveillance program for osteosarcoma and potential exposure to teriparatide. Presented at the 36th meeting of the Scandinavian Sarcoma Group; October 2013.
Midkiff KD, Von Scheele BG, Gilsenan AW, Ceberg J, Alvegård T. Progress update for the postmarketing adult osteosarcoma surveillance study in five Nordic countries. Poster presented at the 36th meeting of the Scandinavian Sarcoma Group; October 2013.
Kruse-Jarres R, Gilsenan AW, Spears J, Kaye JA. Prospective study of plasma-derived factor VIII/vWF in immune tolerance induction therapy: the SPIRIT registry. Poster presented at the Annual Meeting of the National Hemophilia Foundation; October 2013.
Harris DH, Midkiff K, Gilsenan A, Kellier N, Masica D, Andrews E. Eight-year results from the US osteosarcoma surveillance study. Poster presented at the 29th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2013. Montreal.
Gilsenan AW, Harris DH, Midkiff KD, Andrews EB, Kellier N, Masica D. Approaches to long-term surveillance for rare cancer events. Poster presented at the 29th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2013. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2013 Aug; 22(Suppl 1):218-9.
Harris DH, Gilsenan AW, Midkiff KD, Harding AA. Navigating the registry-specific approval process for a long-term drug safety surveillance study. Presented at the NAACCR - North American Association of Central Cancer Registries; June 2013.
Midkiff KD, Harris DH, Gilsenan AW, Powell GL. Variations among cancer registries in accessing patients for a drug safety surveillance study. Poster presented at the NAACCR; June 2013.
Gilsenan AW, Andrews EB. Considerations and strategies for benefit-risk assessment in the real-world setting. In: Sashegyi A, Felli J, Noel R, editors. Benefit-risk assessment in pharmaceutical research and development. 1st ed. Boca Raton: United States. CRC Press; 2013. p.153-64.
Gilsenan AW, Harris DH, Midkiff KD, Andrews EB, Massica D. Seeing the big picture in long-term surveillance for rare events. Presented at the North American Association of Central Cancer Registries Annual Conference; 2013.