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市場調查報告書

醫藥學術專員 (MSL) 建立跟關鍵意見領袖 (KOL) 的關係:新法規下的最適合有效半徑和反應

MSL-KOL Engagement: Optimal reach and response under new rules

出版商 FirstWord 商品編碼 204939
出版日期 內容資訊 英文 63 Pages
商品交期: 最快1-2個工作天內
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醫藥學術專員 (MSL) 建立跟關鍵意見領袖 (KOL) 的關係:新法規下的最適合有效半徑和反應 MSL-KOL Engagement: Optimal reach and response under new rules
出版日期: 2015年07月01日 內容資訊: 英文 63 Pages
簡介

在美國及歐洲中法規的修改和遵守必要條件的變更持續,對醫藥學術專員 (MSL) 來說,跟關鍵意見領袖 (KOL)建立強力關係成為困難的課題。

本報告提供醫藥學術專員 (MSL) 在這個環境下面臨課題相關專家採訪、頻繁的法規修改造成的MSL和KOL的關聯性變化、MSL的遵守及責任制的企業之減輕負擔策略範例、在新環境中MSL需要的技術、知識、訓練、資訊明確指示規則的影響、新法規下的資料記錄、追蹤範例等相關彙整。

摘要整理

調查對象

透明度、學術交流、財務資訊的明確指示

新的法律規章的MSL的影響

  • MLS所扮演的角色
  • 產業的決策和MSL的除外
  • MSL和KOL動態的變化

MSL的法規遵守

  • 政策、責任制、訓練
  • 內部的防火牆
  • 改變為公平市場價值補償
  • 資料的記錄與追蹤
  • 學術交流與非標籤藥物的聯絡方式
  • 各國的遵守狀態

新法規下的MSL和KOL的關係性

  • KOL對透明度與明確指示的反應
  • 對KOL的新法規的通知
  • 明確指示:是好事嗎?
  • MSL、KOL的聯合的重要成功要素
  • 效能測量的標準

主要調查結果

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目錄

Delivering optimal MSL performance in terms of building strong KOL relationships remains a formidable challenge as regulations and compliance requirements continue to evolve across the US and Europe. More stringent rules that govern MSL-KOL interaction are barriers that MSL directors and managers must overcome if they are to grow value in their MSL teams.

FirstWord's latest report, ‘MSL-KOL Engagement: Optimal Reach and Response Under New Rules’, provides the most current insight from leading subject experts familiar with the challenges MSLs face today. Learn from their approach to tackling the issues and about the solutions they have deployed to stay ahead. Benchmark your MSL-KOL engagement strategies, policies, processes and systems against leading pharma companies.

Get Answers to Key Questions

  • How has increased regulation changed the MSL-KOL dynamic?
  • How can the knowledge and experience of US MSLs benefit European MSLs, and vice versa?
  • Why are some pharma companies aiming for a consistent approach to MSL compliance management despite differences in rules between countries?
  • How is the evolving regulatory environment changing the skill-set and training MSLs need?
  • How are companies tracking and recording MSL-KOL interaction data?
  • How can the increased administrative burden on MSLs be reduced so they have more time to spend with KOLs?

Key Benefits

  • Understand the critical success factors for MSL-KOL engagement in an environment of increased scrutiny
  • Learn how different companies are handling the increased burden of MSL compliance and accountability
  • Gain knowledge on how varying rules across the US and Europe are driving MSL compliance decisions at a global level
  • Understand what new skills, knowledge and training MSLs are needed to excel in an evolving regulatory landscape
  • Learn how MSLs are helping KOLs manage the increased complexity that transparency brings to their relationship with pharma
  • Understand the impact of differing regulations on MSL-KOL interactions in the US and key European markets
  • Evaluate how disclosure rules have affected fair market value compensation
  • Learn how companies record and track data required under new rules

Insight and Analysis Sources

Get insights from leading pharma companies and experts including:

  • UCB
  • Shire
  • Roche
  • Daiichi Sankyo
  • Scientific Advantage
  • Arx research
  • Philips Healthcare
  • A mid-sized European pharma company
  • Cubist International

Table of Contents

  • Executive summary
  • Contributors
  • Transparency, scientific exchange and financial disclosure
  • The impact of the new regulations on MSLs
    • The medical science liaison role
    • Keeping MSLs out of business decisions
    • Changes to the MSL-KOL dynamic
  • Ensuring MSL compliance with regulations and guidelines
    • Policy, accountability and training
    • The internal firewall
    • Changes to fair market value compensation
    • Recording and tracking data
    • Scientific exchange and off-label queries
    • Compliance across countries
  • MSL-KOL relationships under new rules
    • KOL reactions to transparency and disclosure
    • Informing KOLs of new rules
    • Is disclosure a good thing?
    • Critical success factors for MSL-KOL engagement
    • Metrics for measuring performance
  • Key findings
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