Risk & Regulation: Grant Productivity

 

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Publications

 

Dugas, Marylène and Janice Graham. (2011) Is consent for research genuinely informed? Using decision aid tools to obtain informed consent in the global South. Accepted, Journal of Global Ethics.

 

Graham, J. et Jones, M. (2010) Rendre evident : une approche symetrique de la réglementation des produits thérapeutiques. (Determining evidence: a symmetrical approach to the regulation of therapeutic products.) Sociologie et societies, 42 (2): 157-184.

 

Holmes, C., Ozdemir, V., McDonald, F., Jones, M. & Graham, J.E. (2010). Standardization and Omics Science: Technical and Social Dimensions are Inseparable and Demand Symmetrical Study. OMICS 14(3): 1-6. Click Here to Access

 

Y.K. Paik, J.E. Graham, M. Jones, F. McDonald, C. Holmes, V. Ozdemir. Interview with Dr. Young-Ki Paik. (2009). President of the Human Proteome Organization (HUPO): Pharmacoproteomics and the Approaching Wave of ‘Proteomics Diagnostics’
Current Pharmacogenomics and Personalized Medicine 7(4): 243-248.

 

Sanou, A., Simboro, S., Kouyate, B., Dugas, M., Graham, J., & Bibeau, G. (2009). Assessment of factors associated with complete immunization coverage in children ages 12-23 months: A cross sectional study in Nouna district, Burkina Faso. BMC International Health and Human Rights 9 (Suppl 1): S10. Click Here to Access 

 

Jones, Mavis and Graham, Janice E. (2009) Multiple institutional rationalities in the implementation of new public policy: an ethnographic examination. Science and Public Policy 36(6): 445-455.

 

Holmes, Christina and Janice E. Graham. (2009). Genetically Modified Organisms as Public Goods: Plant Biotechnology Transfer in Colombia. Culture & Agriculture 31(1):26-38.

 

Ozdemir, V., Graham, J. E., Godard, B. (2008). Race as a variable in Pharmacogenomics Science: From empirical ethics to publication standards. Pharmacogenetics and Genomics 18: 837-841.

 

JE Graham (2008). Facilitating regulation: the dance of statistical significance and clinical meaningfulness in standardizing technologies for dementia. BioSocieties 3(3):241-263.

 

Ozdemir, V., Williams-Jones, B., Graham, J.E., Preskorn, S.H., Gripeos, D., Glatt, S.J., Friis, R.H., Reist, C., Szabo, S., Lohr, J., Someya, T. (2007) Asymmetry in scientific method and limits to cross-disciplinary dialogue: Towards a shared language and science policy in pharmacogenomics and human disease genetics. Journal of Investigative Medicine 55 (3): 130-141.

 

Graham, Janice and Ritchie, Karen (2006). Mild Cognitive Impairment: ethical considerations for nosological flexibility in human kinds. Philosophy, Psychology and Psychiatry 13(2): 31- 43.

 

Graham, Janice (2006). Reifying Relevance in Mild Cognitive Impairment: An appeal for care and caution. Response to Commentaries. Philosophy, Psychology and Psychiatry 13(1): 57- 60.

 

Ozdemir, Vural; Eleni Aklillu, Steven Mee, Leif Bertilsson, Lawrence J. Albers, Janice E. Graham, Michael Caligiuri, James B. Lohr, Christopher Reist (2006). Pharmacogenetics for off-patent antipsychotics: re-framing the risk for tardive dyskinesia and access to essential medicines. Expert Opinion on Pharmacotherapy 7(2): 119-133.

 

Graham, Janice (2005). Smart Regulation: Will the government’s strategy work? Canadian Medical Association Journal 173 (12): 1469-1470.

 

Ozdemir V, Kalow W, Tothfalusi L, Bertilsson L, Endrenyi L, Graham, J.E. (2005). Multigenic control of drug response and regulatory decision-making in pharmacogenomics: the need for an upper bound estimate of genetic contributions. Current Pharmacogenomics; 3(1) 53-71.

 

Graham, J.E. (2005). Qui s’occupe des réglementations? Les technologies émergentes et les “smart regulations.” Agora. Click Here to Access

 

 

 

 

Graham, Janice. “Governing Clinical Trials: Preventing Real World Risks at the Gate”. Canadian Anthropology Society (CASCA). Vancouver, Canada. May 13-15, 2009.

 

Graham, Janice. Regulatory science and politics: a case study of emerging biologic technologies in Canada. Society for the Social Studies of Science, Rotterdam, The Netherlands, August 20-23, 2008.

 

Graham, Janice and Mavis Jones. “Regulatory modernization and relevant expertise”. Technoscience and Regulation Research Unit presentation to Health Canada Atlantic Staff Retreat. (Wolfville, Nova Scotia. December 4, 2008).

 

Graham, Janice and Mavis Jones. “Regulatory modernization and relevant expertise”. Technoscience and Regulation Research Unit presentation to Health Canada Atlantic. (Halifax, Nova Scotia. October 21, 2008).

 

Graham, Janice. “Accessing and Rights of Access” Society for the Arts in Dementia Care. Creative Expression, Communication and Dementia: Mindscapes 2008, May 2008 Vancouver, BC http://www.cecd-society.org/2008/

 

Graham, Janice. Invited Lecturer. “Smart regulation, progressive licensing and the myth of deliberative democracy: Regulatory Practices at Health Canada.” University of Manitoba, Community Health Sciences Colloquium & Grand Rounds, April 18th, 2008.

 

Graham, Janice. A symmetrical approach to regulation: will the scientists and policy wonks please rise? Invited workshop “Regulating Biotechnology Products: at the interface between science and ethics.” Université Laval, Institut d’ethique appliqué, March 20, 2008.

 

Graham, Janice. Invited Lecturer. “Balancing risk: scientific evidence, political expediency and public opinion in the drug approval process in Canada” and “Contesting Paradigms of Loss in Again: the science, politics and everyday life of recognizing effective treatments for dementia.” University of Saskatchewan, March 12-13, 2008.

 

Holmes, Christina. “Regulating Boundary Objects: Adapting the ‘scientific view’ of genetically modified organisms (GMOs) to regulation.” Canadian Anthropological Society Meetings (CASCA) (Ottawa, May, 2008).

 

Jones, Mavis. “Embattled frontiers and growing pains: negotiating ‘relevant’ expertise in Canadian health regulation.” For session: (Re)Thinking Expertise: Spaces of Production, Performance, & the Politics of Representation. UK Royal Geographical Society (London, UK, August 30-September 1, 2008).

 

Jones, Mavis. “Integrating public input in the evidence base for safety review.” For session organized by Health Canada: Public involvement in the regulation of health products: methodologies for assessing and incorporating public input in regulatory decision making. Drug Information Agency (Boston, USA, June 22-26, 2008).

 

Jones, Mavis. “Multiple rationalities in evidence-based decision making.” For session: Authority, agency and bodies: sites of encounter in the anthropology of regulation. Canadian Anthropology Society (CASCA) (Ottawa, Canada, May 8-10, 2008).

 

Jones, Mavis. “Getting the Full Picture: Defining relevant evidence and expertise in regulatory review of marketed products.” Paper for symposium: Researchers 'in the field' at Health Canada: cultures of evaluating drugs, biologics, and natural health products. GEIRSO: The Pharmaceutical Life Cycle Conference – Interdisciplinary Perspectives on Diversity and Complexity. Montréal, Canada, October 14-17, 2007.

 

Jones, Mavis. “Qual + Quant = ? Integrating the social with the technical in a regulatory evidence base.” International Symposium on Technology and Society (ISTAS), Las Vegas, USA. May 31-June 2, 2007.

 

Toller, Elizabeth. “Intersections of Intellectual Property, Regulation, and Natural Health

Products: Knowledge Practices in Drug Commercialization.” Canadian Anthropology Society (CASCA), Toronto, Canada, May 8-12. 2007

 

Graham, Janice. Things that fall short in translation: A comparison of health technology assessment and regulatory approval. Paper accepted for GEIRSO 2nd International Conference, The Pharmaceutical Lifecycle: Interdisciplinary Perspectives on Diversity and Complexity. Theme: 2.2 Regulation: economic, ethical and political issues. Montreal. Oct 14-17, 2007.

 

Jones, Mavis. “Integrating patient and consumer voices in evidence-based regulatory decisions about risks and benefits” (with Mary Moreland, Health Products and Food Branch). The Regulatory Craft in Nova Scotia, Halifax, Canada. November 20, 2007.

 

Graham, Janice. Behind closed doors: Negotiations for the regulatory approval of drugs. Drug Trajectories V. Ways Of Regulating: Therapeutic agents between plants, shops and consulting rooms. Max- Planck Institut fűr Wissenchaftsgeschichte, Institut fűr Geschichte der Medizin (Charité Berlin) and CERMES (Paris). Berlin Nov 30- Dec 2, 2006.

 

Graham, Janice. World Health Organization. Expert Committee on Biological Standardization. Geneva; October 23-27, 2006. Click Here to Access 

 

Graham, Janice. Regulating Biopharmaceuticals. Regulating Biotechnologies Symposium, Leeds Social Science Institute. Organized by Anne Kerr, University of Leeds, U.K. July 24-25, 2006. Click Here to Access

 

Graham, Janice. Regulating risks and uncertainty: An anthropological exploration of approving emerging drugs. Sociology and Anthropology Colloquium Series, Carleton University, March 13, 2006.

 

Graham, Janice. From a NOD to a NOC with a wink: smart policy and regulatory practices. Invited talk for Department of Community Health & Epidemiology Colloquium, Dalhousie University, Halifax, December 6, 2005.

 

Graham, Janice. Invited Presentation, Health Canada: “A Cultural Study of Regulation”. Biological & Genetic Therapies Directorate, Health Canada, Sept 21, 2005.

 

Graham, Janice. Regulatory Cultures. Works in Progress Colloquium, Department of Bioethics, Dalhousie University, Halifax, Sept 19, 2005.

 

Graham, Janice. Invited Workshop: “National Pharmaceutical Strategy Working conference: Strengthening the evaluation of real world drug safety and effectiveness”. Health Canada, Ottawa Sept 13-15, 2005. Click Here to Access

 

Graham, Janice. The Polio Vaccine: The First 50 Years and Beyond. International Association for Biologicals Conference. Toronto, June 5-7, 2005. (special invitation to attend, no paper delivered). Click Here to Access 

 

Holmes, Christina. “GMO Scientists: Perspectives on GMOs, controversy and regulation in Canada and Colombia”. Presented at the Health Canada Seminar Series (Ottawa, ON, September 28, 2005).

 

Graham, Janice. From a NOD to a NOC with a wink: how drugs (that don’t work) get approved. American Anthropological Association 104th Annual Meeting, Dec 1, 2005, Washington, DC, USA.

 

Graham, Janice. “Biologicals are illogical”: Making radiopharmaceuticals fit into regulatory systems. Joint meeting of the Society for North American Anthropology, Canadian Anthropology Society and Yucatan Anthropology Society, May 5, 2005, Merida, Mexico.

 

 

 

North South Workshop for an African decision-making framework for vaccines – Part 1. Burkina Faso, Africa. February 28 – March 3, 2009.

 

North South Workshop for an African decision-making framework for vaccines – Part 2. Montreal, Canada. April 27 – 28, 2009.

 

Reassessing the Governance of Clinical Trials: Preventing Real World Risks at the Gate. A Technoscience & Regulation Research Workshop. Halifax, Nova Scotia. March 9-10, 2009.

 

Holmes, Christina and Janice Graham. Authority, agency and bodies: sites of encounter in the anthropology of regulation. Presenters: Jennifer Cuffe, Dianne Grant, Kathy Buddle-Crowe, Christina Holmes, Mavis Jones, Richard Lee, Robyn Lim (Health Canada), Harriet Rosenberg, Elizabeth Toller, James Waldram. Canadian Anthropology Society (CASCA), (Ottawa, Canada, May 8-10, 2008).

 

 

 

Jones, Mavis and Mary Moreland (Health Canada). “Extending the evidence base to enhance the quality of regulatory safety review of health products”. Health Canada Science Forum (Ottawa, Canada, November 7-9, 2007).

 

Graham, Janice Smart Regulation: Does Accelerating Access to New Drugs Improve the Drug Approval Process? 18th Annual CHSPR Health Policy Conference: Towards a National Pharmaceutical Strategy, Lessons from Abroad, February 9-10, 2006, Vancouver, B.C. Click Here to Access 

 

 

 

Graham, Janice. Report on Technical Discussions on modernization strategy to the Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Health Canada. October 2010.

 

Toller, Elizabeth (2008). Framing Regulation as Competitive Advantage: An Anthropological Analysis of Natural Health Product Commercialization. (MA thesis, Dalhousie University).

 

Graham, Janice. Consultation- World Health Organization. Expert Committee on Biological Standardization. Geneva; October 23-27, 2006. Click Here to access