McKesson Corporation · NYSE:MCK
McKesson — ER/LA Opioid Analgesics REMS CE National Provider Organization Webinar (May 2013)
15 slides from McKesson's conference presentation, May 7, 2013
Slide 1: ER/LA Opioid Analgesics REMS Education: What CE Providers Should Know
ER/LA Opioid Analgesics REMS Education: What CE Providers Should Know May 7, 2013 -1- Copyright © 2013 Campbell Alliance, Ltd. All Rights Reserved. Copyright © 2013 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. Confidential and Proprietary.
Slide 2: Housekeeping: Before We Begin
ER/LA Opioid Analgesics REMS Education Webinar Housekeeping Before We Begin… Attendees are asked to mute their lines when they are not speaking The slides from today’s webinar will be posted on the RPC Website: http://www.er-la-opioidrems.com Responses to questions received during today’s Webin
Slide 3: Agenda
ER/LA Opioid Analgesics REMS Education Webinar Agenda CE National Provider Organization Webinar: Contents Overview CE Subteam / RPC Introductions and Acknowledgements 4:00pm-4:05pm Background on ER/LA Opioid Analgesics REMS and the RPC 4:05pm-4:10pm Review of Requirements for REMS-compliant CE and I
Slide 4: Introductions – MedBiquitous, BU, CO*RE and RPC Continuing Education Subteam
ER/LA Opioid Analgesics REMS Education Webinar Introductions – MedBiquitous, BU, CO*RE and RPC Continuing Education Subteam Today’s presentation will include presentations from MedBiquitous, the organization that developed the MEMS Specification, the first two CE Providers implementing REMS-complian
Slide 5: Background on ER/LA Opioid Analgesics REMS and the RPC
ER/LA Opioid Analgesics REMS Education Webinar Background on ER/LA Opioid Analgesics REMS and the RPC The REMS Program Companies are hosting this Webinar to provide information and answer questions about the 2013 CE Grant RFA and the use of MEMS specifications in reporting of CE activity data. Who i
Slide 6: Review of Requirements for REMS-compliant CE
ER/LA Opioid Analgesics REMS Education Webinar Review of Requirements for REMS-compliant CE Requirements for REMS-Compliant CE are spelled out in the REMS and the FDA Blueprint. FDA-Mandated Requirements for REMS-Compliant CE No promotional content on RPC website: REMS-related info only Training
Slide 7: Introduction of Long-Term CE Evaluations
ER/LA Opioid Analgesics REMS Education Webinar Introduction of Long-Term CE Evaluations FDA has mandated Long-Term Evaluation of RPC-supported CE (separate from any assessment/evaluation associated with the actual CE activity) Evaluations of Long-term CE Performance Outcomes To be conducted by CE
Slide 8: Agenda
ER/LA Opioid Analgesics REMS Education Webinar Agenda CE National Provider Organization Webinar: Contents Overview CE Subteam / RPC Introductions and Acknowledgements 4:00pm-4:05pm Background on ER/LA Opioid Analgesics REMS and the RPC 4:05pm-4:10pm Review of Requirements for REMS-compliant CE and I
Slide 9: Introduction/Overview of MedBiquitous and the MEMS 2.0 Initiative
MEMS Specifications for ER/LA REMS Education Introduction/Overview of MedBiquitous and the MEMS 2.0 Initiative MedBiquitous MEMS 2.0 Technical Standards will be employed to facilitate consistent collection and reporting of CE outcomes data. Who is MedBiquitous and what are MEMS? What is the MEMS 2.0
Slide 10: Practical Application of Revised MEMS Specifications / Implementation Guide
MEMS Specifications for ER/LA REMS Education Practical Application of Revised MEMS Specifications / Implementation Guide The MedBiquitous Metrics Working Group has revised the MEMS Specifications and designed an Implementation Guide that provides instructions for use of MEMS in ER/LA Opioid REMS CE.
Slide 11: Agenda
MEMS Specifications for ER/LA REMS Education Agenda CE National Provider Organization Webinar: Contents Overview CE Subteam / RPC Introductions and Acknowledgements 4:00pm-4:05pm Background on ER/LA Opioid Analgesics REMS and the RPC 4:05pm-4:10pm Review of Requirements for REMS-compliant CE and Int
Slide 12: Open Forum for Provider Organizations’ Questions and Discussion
MEMS Specifications for ER/LA REMS Education Open Forum for Provider Organizations’ Questions and Discussion Question 1: Regarding Audits – Accreditors will serve as auditors for REMS-compliant RPC-supported. Will Accreditors audit their own activities and how will interactions work? Response (RPC
Slide 13: Open Forum for Provider Organizations’ Questions and Discussion (Cont.)
MEMS Specifications for ER/LA REMS Education Open Forum for Provider Organizations’ Questions and Discussion (Cont.) Question 2: It was noted as part of the REMS compliant CE that providers will establish a passing criteria for the assessment. This is not mentioned in the FDA Blueprint, so where doe
Slide 14: Concluding Remarks: Outcomes of 2012 RFAs and 2013 RFA Posting Information
ER/LA Opioid Analgesics REMS Education Webinar Concluding Remarks: Outcomes of 2012 RFAs and 2013 RFA Posting Information The RPC approved 5 grants from the 2012 RFAs and will be conducting the 2013 RFA in the coming months. Grants Supported from 2012 RFA Cycle(s) 2013 Grant Cycle: RFA 03##12 Primar
Slide 15: Concluding Remarks: Materials for Reference and RFA Posting Information
ER/LA Opioid Analgesics REMS Education Webinar Concluding Remarks: Outcomes of 2012 RFAs and 2013 RFA Posting Information Materials for Reference The slides from today’s webinar will be posted on the RPC Website: http://www.er-la-opioidrems.com Responses to questions received during today’s Webi
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