Outsourcing to AAHRPP Accredited IRBs vs Creating a Local Regulatory Compliant IRB
Regulatory Outsourcing: ''TO or Not TO"
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Transcript of Regulatory Outsourcing: ''TO or Not TO"
Regulatory Outsourcing : Thought Leadership webinar
Thanks for joining! Stay tuned ..
Introductions
Alan’s wisdom
MakroCare’s market view
Q/A
What we’ll cover
About speakers today !
40 Years Pharma / RA Exp(25 in Big Pharma)Pharma International, Switzerland
15+ years ExperienceBD Director, MakroCare
I’m Alan & my topics …
• Overview and Objectives • Rationale • Sponsor/ Manufacturer• Regulatory Affairs Vendor• Compare and Contrast• Summary• The best way forward
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
Objective
RA Vendor
• Practical implications• Suggestions
Sponsor/Manufacturer
Compare & Contrast
Rationale
• Regulatory affairs- a basic essential• Workloads• Time-frames• Priorities• Regulatory compliance• Risk management• Strategic objectives
Sponsor / Manufacturer
• Research and develop business ideas• Use available resources and “ know-how” • Competitive advantage • “Fast-Track” Activities• Costs• Training• Timeframes• Positive advantages
Sponsor / Manufacturer
• Contractual obligations• Confidentiality agreements • Terms and conditions• Milestone payments• Exclusivity
Reg Affairs Vendor
• Knowledge and experience• Resources• Flexibility• Speed & efficiency• Prioritisation• Regulatory intelligence• Benchmarking
Reg Affairs Vendor
• Contractual agreements• Liability issues• Time constraints• Milestone payments• Regulatory Authorities
Pros & Cons for both ..
•In-House•On-site•Collaborative•Hourly rates
•Outsourced•External venue•Independent•Pauschal payments
Looking Out
Looking In
Additional Factors(1)
• Mergers and acquisitions• Restructuring • Optimisation endeavours• Tender business• Budgets• Confidentiality• Human resources• Market comparisons
Additional Factors(2)
• Recommendations
• «Small is beautiful» ?
• Local / Regionl / International / Global
• Cultural aspects
Practical Experiences
•From the large company looking for support
•From the smaller consultancy offering help
•From within the hybrid situation
Summary of the Situation
• Where are we at present?
• Have additional aspects been covered?
• Areas of interest uncovered?
• General agreement / Differing opinions
MakroCare’s market view
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
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 ..
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
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 ?
Current Outsourcing trends
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
Low High
•Pick based on your needs•Pick based on your company goals•Pick based on your budgets
How much to outsource?