PPT-Session II: CTTI ICH E6 Survey and Stakeholder Input

Amy Corneli PhD MPH Associate Professor Duke University Lead Social Scientist CTTI Disclaimer The views and opinions expressed in this presentation are those of the individual presenter and do not necessarily reflect the views of the. Conducting a Stakeholders Analysis essentially means: . Identifying all the relevant groups involved in (directly involved or indirectly affected by) a given situation. Analysing their perspectives (i.e. interests, needs, positions, resources). Keep Satisfied. Manage Closely. Monitor. Keep Informed. High. Interest. Low. Low. High. Power. On this grid, you can plot the various stakeholder groups that you’ve identified in your Stakeholder Outreach Chart. TIOGA. , . ND . PIPELINE SPILL . CLEANUP. TIOGA . Pipeline Spill. Pipeline release of . 20,600 . bbls of Bakken crude oil discovered by landowner (September 2013). Source of release: probable lightning strike that damaged the near surface pipeline. .. Rob Hemmings, Statistics and PK Unit manager, MHRA . CHMP member, SAWP chair, BSWP / MSWG member. Contents. Need . for a new framework . Why ICH?. How?. Who?. When?. What?. What next?. Example to support discussion. Jonathan Prescott – December 13. th. 2013. Change Management. “Attempts to implement planned change face numerous barriers, but using a framework . proactively. rather than . retrospectively. can help eliminate some of the potential problems, and address and act on others.” (Mitchell, 2013). Dave Wakeman, PMP . Principal. Wakeman Consulting Group. What We Are Discussing. Stakeholders And How To Communicate With Them. Stakeholder: Any Person, Organization, Or Business That Has A Concern In Your Project…Either Internal Or External. . Tominaga. Ph. D.. Food and Drug Evaluation Center, Osaka City Univ. Hospital. International Regulatory Harmonization Amid Globalization of. Biomedical Research & Medical Product Development: An . .. Josua 1, 9.  . Ich will euch trösten, wie einen seine Mutter tröstet. . Jesaja 66, 13. Ein Mensch sieht, was vor Augen ist; . Gott aber sieht das Herz an.. 1. Samuel 16, 7. Der HERR ist mein Hirte.. Introduction . This presentation will cover:-. Brief project outline. Stakeholders – who they are. Theory – Onion model and Power/Interest Matrix. Suitable methods of communication . Stakeholders. A Stakeholder Map . Starts with a central theme. Uses lines to demonstrate associations. Provides keywords for clarity. Employs proximity to gauge strength of the relationship. Adapted from: https://simplemind.eu/how-to-mind-map/basics/. Dr.. G. . Hima. . Swetha. . PDF, Obstetric medicine, JIPMER. .. Date : Monday,18. th. January 2021(online). Case summary. Received a 32 yr . Primi. /38 weeks from local Govt. hospital, in view of antepartum . Public-Private Partnership. Co-founded by Duke University & FDA . Involves all stakeholders. Approx. 80+ members. Participation of 400+ more orgs. MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. Ondřej Částek. castek@econ.muni.cz. 2. Content. Shareholder and stakeholder approach. A move between these approaches. Who is a stakeholder . Stakeholder classification . Stakeholder analysis. Stakeholder attributes. Stakeholder Meeting. Tom Leckey, Joelle Michaels, Alan Swenson. May 15, 2012 | Washington, DC. Agenda. 2. Welcome. CBECS background. 2012 CBECS general changes. 2012 CBECS changes and new questions by questionnaire section.