Best Practices in Establishing Medical Affairs Capabilities in Emerging Countries: Using Structure, Staffing, and Responsibilities to Create an Effective Medical Affairs Group in TMEA

Industries Profiled:
Pharmaceutical; Biotech; Chemical; Health Care; Medical Device; Biopharmaceutical; Clinical Research; Laboratories


Companies Profiled:
Abbvie; AstraZeneca; Celgene; Gilead Sciences; Janssen; Novartis; Pfizer; Roche; Sanofi; Takeda Pharmaceuticals

Study Snapshot

Best Practices, LLC engaged 11 Medical Affairs executives from 10 leading pharmaceutical companies with operations in the TMEA region. Almost half of the research partners serve as Directors or Heads of Medical Affairs function in TMEA region.

Key topics covered in this report include:

• Medical Affairs Responsibilities
• Country-Level Medical Affairs Structure, Staffing and Activities
• Field-Based Medical Staff Structure &Staffing
• Field-Based Medical Staff Responsibilities & Compliance
• Field-Based Medical Staff Performance & Virtual Meetings

• Most Participants Utilize Almost all Key Medical Affairs Functions & Roles in TMEA Region: More than 60% of study participants employ all the key medical affairs functions - except publication & medical writing. Likewise, more than half use medical affairs roles such medical advisors, clinical research, MSLs, medical directors, medical affairs directors, PV/safety training and medical information and call centres.
• MSLs in TMEA have Scope of Work Similar to Mature Markets: Similar to mature markets, MSLs in the TMEA region have responsibility for 17 key MSL activities. All participants rely on MSLs for KOL management, field-based work, congresses, CI, clinical study support and education programs & symposia.
• Countries in TMEA have 4 to 6 MSLs, on Average: On average, companies in the study have 4 to 6 MSLs for each of the countries in the TMEA region. For span of control, participants said that each MSL manager is responsible for 5 MSLs, on average.

I.	Executive Summary: Methodology, Participants, Recommendations & Key Findings	pgs. 3-10
	Study Structure & Design
	Universe of Learning: Benchmark Class
	Recommendations
II.	Benchmark Class Profile	pgs. 11-15
	Titles
	Company Size
	Survey Perspective
	Structure
III.	Medical Affairs Top Activities & Responsibilities	pgs. 16-25
	Top Activities
	Responsibilities
IV.	Affiliate / Country Level Medical Affairs	pgs. 26-37
	Structure
	Staffing
	Activities
V.	Field-Based Staff	pgs. 38-41
	Structure & Staffing
	Launch Activities
	Launch Timing
	Responsibilities & Compliance
	Performance & Virtual Meetings
VI.	Field-Based Staff, Responsibilities & Compliance	pgs. 42-47
	Performance Measurement
	Virtual Interactions
	Clinical Studies
VII.	Field-Based Medical Staff, Measuring Performance & Virtual Interactions	pgs. 48-52
	Performance Measurement
	Virtual Interactions
	Clinical Studies

• Primary responsibility for each of the listed medical affairs activities
• Primary responsibility for each of the listed promotional and non-promotional medical affairs activities
• Primary responsibility for each of the listed strategy and project management medical affairs activities
• Primary responsibility for each of the listed KOL management and engagement activities
• Primary responsibility for each of the listed medical affairs training and support activities
• Primary responsibility for each of the listed medical affairs safety and compliance activities
• Primary responsibility for each of the listed clinical research related medical affairs activities
• Top medical affairs activities that have the greatest positive impact on customers

• Current affiliate/country organizational structure of participating companies
• City in which participants’ affiliate/country office is located
• Whether affiliate/country office supports neighboring countries?
• Functions that are part of medical affairs in the affiliate/country level
• Roles present within affiliate/country medical affairs function
• Turkey country-level medical affairs structure: one top 10 pharma company
• UAE country-level medical affairs structure: two top 10 pharma companies
• Three structural attributes common to medical affairs in TMEA countries
• Country and regional level breakdown of medical affairs FTE allocation by role
• Outsourcing of medical affairs activities, activities outsourced and total number of medical affairs staff in affiliate/country offices
• Product launch activities in which affiliate/country level team takes part in
• Timing of affiliate/country level teams’ involvement in product launch activities

• Field medical team makeup and reporting
• Product launch activities in which affiliate/country level team takes part in
• Timing of affiliate/country level teams’ involvement in product launch activities

• Level of MSL interaction: monthly goal vs. actual number of interactions by MSLs (face to face and virtual)
• MSL responsibilities
• Platform for documenting interactions with healthcare professionals (HCPs)
• Requirements for documenting interactions with HCPs
• Frequency of are compliance checks done in regards to documenting interactions with thought/key opinion leaders, monitoring responsibility and steps taken when there are issues of non-compliance in regards to documenting interactions with thought/key opinion leaders

• Metrics used to track the performance of field medical/MSL staff
• How medical information inquiries are handled
• Key performance indicators (KPIs) or metrics used to track the performance in medical information function
• Use of virtual platforms used by MSLs
• Plans to expand virtual interactions
• Number of company sponsored clinical studies and investigator initiated studies being conducted annually