Download - Regulatory Outsourcing: ''TO or Not TO"
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Regulatory Outsourcing : Thought Leadership webinar
Thanks for joining! Stay tuned ..
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Introductions
Alan’s wisdom
MakroCare’s market view
Q/A
What we’ll cover
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About speakers today !
40 Years Pharma / RA Exp(25 in Big Pharma)Pharma International, Switzerland
15+ years ExperienceBD Director, MakroCare
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I’m Alan & my topics …
• Overview and Objectives • Rationale • Sponsor/ Manufacturer• Regulatory Affairs Vendor• Compare and Contrast• Summary• The best way forward
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Overview
To Outsource or Not to Outsource•Should you consider outsourcing or not•What to Outsource & what not to•Hybrid Models possible•Sharing practical experiences
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Objective
RA Vendor
• Practical implications• Suggestions
Sponsor/Manufacturer
Compare & Contrast
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Rationale
• Regulatory affairs- a basic essential• Workloads• Time-frames• Priorities• Regulatory compliance• Risk management• Strategic objectives
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Sponsor / Manufacturer
• Research and develop business ideas• Use available resources and “ know-how” • Competitive advantage • “Fast-Track” Activities• Costs• Training• Timeframes• Positive advantages
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Sponsor / Manufacturer
• Contractual obligations• Confidentiality agreements • Terms and conditions• Milestone payments• Exclusivity
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Reg Affairs Vendor
• Knowledge and experience• Resources• Flexibility• Speed & efficiency• Prioritisation• Regulatory intelligence• Benchmarking
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Reg Affairs Vendor
• Contractual agreements• Liability issues• Time constraints• Milestone payments• Regulatory Authorities
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Pros & Cons for both ..
•In-House•On-site•Collaborative•Hourly rates
•Outsourced•External venue•Independent•Pauschal payments
Looking Out
Looking In
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Additional Factors(1)
• Mergers and acquisitions• Restructuring • Optimisation endeavours• Tender business• Budgets• Confidentiality• Human resources• Market comparisons
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Additional Factors(2)
• Recommendations
• «Small is beautiful» ?
• Local / Regionl / International / Global
• Cultural aspects
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Practical Experiences
•From the large company looking for support
•From the smaller consultancy offering help
•From within the hybrid situation
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Summary of the Situation
• Where are we at present?
• Have additional aspects been covered?
• Areas of interest uncovered?
• General agreement / Differing opinions
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MakroCare’s market view
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18© 2015 MakroCare. All Rights Reserved. www.makrocare.com
AwardsYear
Established
Over 15 years of Life Sciences Core Consulting experience
1996(HQ:NJ,USA) Privately held
Global Access
14 Global Offices
Clients
8 of Global Top 20150+ Small/Mid-level
ISO 9001 ISO 14155ISO 27001 ISO 20000
Employees
650+ FTEs140+ Consultants
Proprietary Frameworks/Tools
NAVAVistaarRIMtrackjarTreeTULAClinMetanoiamNAAMmEDCmIRT
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Costs Global Headcount
•Lower margin products maintenance• Smaller affiliates support•Routine / established tasks• Low end work
• Expansion•Local Liaison• International reg intel• Mergers
•Headcount freeze•Sporadic peaks•RA seen as cost center• Short-term niche help
Outsource only for these reasons ..
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Established products life cycle Labeling Operations Publishing BPO (eg.. xEVMPD data entry)
Large
HA advisory in new regions Regulatory Strategy Regional/Local representation Localization (Labeling / Dossier formats)
Midsize
Regulatory Strategy Dossier development CMC advisory HA liaison / Pre-Meets
Small
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Vendor OptionsBest-of-Breed or Global ??
Global Consulting firms
Regional RA Vendors
CROs / BPOs
Independent consultants
Each comes with their baggage, what bag you need ?
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Current Outsourcing trends
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What type of vendor ?
Vendors need to fit “ in” your vision & your goals. Not other way round.
If « Outsourcing » word is not comfortable in your company,
you can name it as ….
Strategic Partner
Insourcing
Consulting
Staffing
SOW
FTE work
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Low High
•Pick based on your needs•Pick based on your company goals•Pick based on your budgets
How much to outsource?