McKesson Corporation · NYSE:MCK
McKesson — ER/LA Opioid Analgesic REMS Program CE Provider Information Webinar (November 2012)
26 slides from McKesson's conference presentation, November 2012
Slide 1: CE Provider Information Webinar
CE Provider Information Webinar -1- Copyright © 2012 Campbell Alliance, Ltd. All Rights Reserved. Copyright © 2012 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. Confidential and Proprietary.
Slide 2: Housekeeping
ER/LA Opioid Analgesic REMS Program Housekeeping Before We Begin… Attendees’ lines will be muted during the presentation New questions should be submitted via the InterCall chat function to the Moderator; the RPC will prepare and provide responses via the RPC Website. Questions submitted in ad
Slide 3: RPC Continuing Education Subteam Members
ER/LA Opioid Analgesic REMS Program RPC Continuing Education Subteam Members The RPC’s Continuing Education (CE) Subteam consists of six CE subject matter experts, who also constitute the RPC’s Grant Review Committee. CE Subteam members will be delivering this Webinar presentation today. RPC CE Subt
Slide 4: Webinar Agenda
ER/LA Opioid Analgesic REMS Program Provider Information Webinar Webinar Agenda Background on ER/LA Opioid Analgesics REMS and the RPC Timing for Grant Requests for 2012 and 2013 Grant Review Cycles Use of the Grant Management System for Grant Requests Review Elements of RFA Overview of Gr
Slide 5: Background of the RPC
ER/LA Opioid Analgesic REMS Program Background of the RPC The REMS Program Companies are hosting this Webinar to provide information and answer questions about the 2012 and 2013 CE Grant RFAs and Grant Review Cycles. Who is the RPC and what is the purpose of the REMS CE activities? The REMS Progra
Slide 6: CE Grant Requirements and Timelines
ER/LA Opioid Analgesic REMS Program CE Grant Requirements and Timelines Grant Applicant Organizations must meet eligibility criteria and specific submission deadlines for consideration for grant funds. What are the criteria used to determine if my How does my organization organization is eligible fo
Slide 7: CE Grant Requests for Application (RFA)
ER/LA Opioid Analgesic REMS Program CE Grant Requests for Application (RFA) The RPC would like to support grants that are innovative, cost-effective, evidence-based prescriber education, focused on addressing gaps in knowledge and prescribing behavior. RFA 010812 and RFA 020912 Support high qualit
Slide 8: CE Grant Requests for Application (RFA) (Continued)
ER/LA Opioid Analgesic REMS Program CE Grant Requests for Application (RFA) (Continued) Grants that are funded will apply all elements of the FDA Blueprint, and will meet the parameters outlined in the CE Grant RFAs. RFA 010812 and RFA 020912 Provider meets eligibility requirements Presents a cl
Slide 9: RPC CE Support and MedBiquitous Standards
ER/LA Opioid Analgesic REMS Program RPC CE Support and MedBiquitous Standards The RPC-supported CE will be required to adhere to CME/CE Accreditation Standards. MedBiquitous MEMS 2.0 Technical Standards will be employed to facilitate consistent collection and reporting of CE outcomes data. Will the
Slide 10: 2012 CE Grant Timelines
ER/LA Opioid Analgesic REMS Program 2012 Expedited RFA 2012 CE Grant Timelines 2012 Standard RFA The CE Grant Review Cycles for the 2012 CE Expedited and Standard RFAs are nearly complete. 2012 2013 CE Grant RFA July Aug. Sept. Oct. Nov. Dec. Jan. Feb. Mar. Apr. May June July Prepare 2012 CE Grant R
Slide 11: Draft Timelines and Key Processes – 2013 CE Grant Timelines
ER/LA Opioid Analgesic REMS Program Draft Timelines and Key Processes – 2013 CE Grant Timelines* The RPC will prepare and release RFA(s) for 2013 CE Activities, on a timeline based on CE activities’ progress toward achieving FDA goals stated in the REMS. 2013 CE Grant RFA Jan. Feb. Mar. Apr. May Jun
Slide 12: CE Grant Submission and Review Process
ER/LA Opioid Analgesic REMS Program CE Grant Submission and Review Process Grant requests are reviewed by two committees, with no single company driving a grant’s decision. Once submitted, grant applicants may be emailed for more information. Once approved, grants are funded in fixed percentages. Gr
Slide 13: Webinar Q&A: Questions Submitted in Advance
Webinar Q&A Questions Submitted in Advance Additional questions can be submitted via the InterCall chat function to “moderator.” Questions will be compiled, reviewed, and responded to offline after this Webinar. -13- Copyright © 2012 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Prop
Slide 14: Questions Submitted in Advance
ER/LA Opioid Analgesic REMS Program Questions Submitted in Advance The following questions were received in advance of this Webinar, via the PMO Email Address (ERLAOpioidREMS@campbellalliance.com). If a program covers all elements of The FDA has defined REMS-Compliant training as: the FDA Blueprint,
Slide 15: Questions Submitted in Advance (Continued)
ER/LA Opioid Analgesic REMS Program Questions Submitted in Advance (Continued) The following questions were received in advance of this Webinar, via the PMO Email Address (ERLAOpioidREMS@campbellalliance.com). In the Grant Application: “Please Operational Metrics: RPC does not feel it is appropriate
Slide 16: Questions Submitted in Advance (Continued)
ER/LA Opioid Analgesic REMS Program Questions Submitted in Advance (Continued) The following questions were received in advance of this Webinar, via the PMO Email Address (ERLAOpioidREMS@campbellalliance.com). Can the RPC provide any information on: There is no minimum or maximum individual award am
Slide 17: Questions Submitted in Advance (Continued)
ER/LA Opioid Analgesic REMS Program Questions Submitted in Advance (Continued) The following questions were received in advance of this Webinar, via the PMO Email Address (ERLAOpioidREMS@campbellalliance.com). When will the November 5, 2012 opioid Depending upon the number of submissions received fo
Slide 18: Thank You for Participating!
ER/LA Opioid Analgesic REMS Program Thank You for Participating! The recorded Webinar will be posted on the RPC Website: http://www.er-la-opioidrems.com Responses to questions received during today’s Webinar will be prepared, approved by the RPC, and provided via the RPC Website (Continuing Educ
Slide 19: Webinar Q&A: Questions Submitted During Webinar
Webinar Q&A Questions Submitted During Webinar The following questions were submitted in the course of the call. Questions have been compiled, reviewed, and responded to in the following slides. -19- Copyright © 2012 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary.
Slide 20: Questions Submitted During Webinar
ER/LA Opioid Analgesic REMS Program Questions Submitted During Webinar The RPC has prepared the following answers for questions received during the CE Provider Informational Webinar. Question RPC Response When will the RPC provide notification of The RPC is working as quickly as possible to review a
Slide 21: Questions Submitted During Webinar (Continued)
ER/LA Opioid Analgesic REMS Program Questions Submitted During Webinar (Continued) The RPC has prepared the following answers for questions received during the CE Provider Informational Webinar. Question RPC Response The limited character requirements of the Applicants should use the attachment feat
Slide 22: Questions Submitted During Webinar (Continued)
ER/LA Opioid Analgesic REMS Program Questions Submitted During Webinar (Continued) The RPC has prepared the following answers for questions received during the CE Provider Informational Webinar. Question RPC Response No, there is no opportunity to make changes to the activity format in a If others h
Slide 23: Questions Submitted During Webinar (Continued)
ER/LA Opioid Analgesic REMS Program Questions Submitted During Webinar (Continued) The RPC has prepared the following answers for questions received during the CE Provider Informational Webinar. Question RPC Response If two accredited providers are partnering as sponsor and co-sponsor, can either on
Slide 24: Questions Submitted During Webinar (Continued)
ER/LA Opioid Analgesic REMS Program Questions Submitted During Webinar (Continued) The RPC has prepared the following answers for questions received during the CE Provider Informational Webinar. Question RPC Response If a program covers all elements of the FDA The FDA has defined REMS-Compliant trai
Slide 25: Questions Submitted During Webinar (Continued)
ER/LA Opioid Analgesic REMS Program Questions Submitted During Webinar (Continued) The RPC has prepared the following answers for questions received during the CE Provider Informational Webinar. Question RPC Response In the Grant Application: “Please describe Operational Metrics: RPC does not feel i
Slide 26: Questions Submitted During Webinar (Continued)
ER/LA Opioid Analgesic REMS Program Questions Submitted During Webinar (Continued) The RPC has prepared the following answers for questions received during the CE Provider Informational Webinar. Question RPC Response Can the RPC provide any information on: There is no minimum or maximum individual a