This document provides information about an upcoming conference on managing partnerships with contract research organizations (CROs). The conference will take place on October 3-4, 2012 in London and will include presentations from pharmaceutical companies and CROs on trends in clinical development outsourcing, developing effective CRO partnerships, and managing regulatory inspections of CRO activities. Pre-conference workshops on October 2 will focus on defining the scope of CRO relationships and ensuring quality in CRO engagements. Key speakers are listed from pharmaceutical companies like Pfizer, Eli Lilly and AstraZeneca and CROs like Quintiles. The document outlines the conference agenda and encourages those in clinical development, outsourcing, and related areas to attend.

1. CedricBurg
Deputy Head of Global Clinical Operations
Teva
AndrewHuxley
Director Outsourcing
EliLilly&Co
GarethLewis
Director Clinical Research
Pfizer
MartinGrosvenor
Sourcing Product Specialist
AstraZeneca
TimHighman
Director Outsourcing
Pfizer
GaryReeves
Clinical Contracts Manager
BiogenIdec
VolkerRonicke
Vice President
Booz&Co
AlbertAgro
President
HNZ-StrategicHoldings
JanetWisely
Chief Executive
HealthResearchAuthority
ClareMorgan
Director of Industry
NIHR
KEY SPEAKERS INCLUDE:
WHY ATTEND THIS EVENT:
• Discuss the strategic rationale for clinical development outsourcing among the
large pharmaceutical companies.
• Learn what clinical development capabilities companies consider vital, and how you
can provide them.
• Investigate to what extent is the design of relationships and associated capabilities
aligned with strategic intent.
• Develop strategy in relationship structure; standard contract or a sophisticated
strategic alliance.
• Hear from industry experts how to solve the current issues with CRO partnerships.
• Network and discuss ideas with key decision makers in pharma, biotech and CROs.
PLUSTWOINTERACTIVEHALF-DAYPRE-CONFERENCEWORKSHOPS
Tuesday2ndOctober2012,HolidayInnBloomsburyHotel,London,UK
SMi present their 4th annual conference on…
Managing Partnerships
with CROs
Wednesday 3rd and Thursday 4th October 2012
Holiday Inn Bloomsbury, London, UK
www.pharmaoutsourcingevent.com
Register online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
REGISTER BY 31ST MAY AND RECEIVE A £300 DISCOUNT
REGISTER BY 29TH JUNE AND RECEIVE A £100 DISCOUNT
B: PartnershipsbetweenPharmaceutical
CompaniesandCROs
Workshop Leaders:
VolkerRonicke,VicePresident,Booz&Co
andPeterBehner,Consultant,Booz&Co
1.30pm-5.30pm
A: CollaborationswithCROs
–Touch-pointsforSuccess
Workshop Leader:
GraemeLadds, Director, PharSafer
8.30am–12.30pm
Sponsored by

2. Register online at www.pharmaoutsourcingevent.com • Alternatively
Supported by
• GlobalStrategicSourcing
• Outsourcing
• ClinicalOperations
• ContractManagement/Administration
• Finance
• InternationalClinicalOperations
• CorporateCounsel
• BusinessDevelopment
Who should attend this conference:
YoushouldattendthiseventifyouareaDirector,AreaHead,ChiefExecutive,Chief
ScientificOfficer,VicePresident,Heads,PrincipalScientistorManagerwithinthe
PharmaceuticalorHealthcareindustrywithresponsibilitiesinthefollowingareas:
• ClinicalDevelopment
• Planning
• R&D
• Accounting/Budgeting
• GlobalClinicalPrograms
• ProjectManagement/Planning
• RiskManagementClinicalTrialProjects
8.30 Registration and Coffee
9.00 Chairman's opening remarks
Tim Highman, Director Outsourcing, Pfizer
Strategic Overview
OPENING ADDRESS
9.10 Trends in outsourcing
• Outsourcing models and strategies
• Considerations around selecting vendors
• Regulations and requirements – recipe for successful
externalization
• Case study – how things can go wrong
• Whats next in outsourcing
Tim Highman, Director Outsourcing, Pfizer
9.50 Outsourcing and regulatory inspections
• Oversight and management of partnerships
• Inspection readiness and quality management
• Inspection findings and corrective actions
• Building for the future
Graeme Ladds, Director, PharSafer
10.30 Morning Coffee
11.00 Partnership factors in sponsor – CRO relationships
• Trends and emerging new models for pharma – CRO partnerships
• Challenges and key success factors
• Outlook to the next level of scale and scope
Volker Ronicke, Vice President, Booz & Co
Peter Behner, Consultant, Booz & Co
11.40 Working with CROs in emerging markets
• Emerging markets
• Sharing responsibilities
• Case study Asia Pacific
• Matching the right trial to the right country
Andrew Huxley, Outsourcing Director, Eli Lilly & Co
12.20 Networking Lunch
Developing a Professional Relationship
1.40 Implementing a new CRO Partnership model in support of improved
cycle time
• Selection of country footprint
• Vendor selection process to optimise success
• Establishing a new operating model – practical considerations
• Service delivery structure
• Ensuring quality and compliance – governance and oversight
considerations
• Progress and challenges to date
Gareth Lewis, Director Clinical Research, Pfizer
2.20 Choosing the right CRO for partnership
• Evaluating your own processes and requirements before choosing a
partner
• Approaches to asses a potential partner
• Developing an in-depth and thorough CMO/CRO questionnaire
• Strategies for short listing the number of potential companies
Martin Grosvenor, Sourcing Product Specialist, AstraZeneca
3.00 Afternoon Tea
3.30 Case study: long-term strategic multilevel flexible partnership with
CROs reduces cost and timelines while ensuring quality and site
satisfaction”
• Cost: key elements of success
• Timelines: streamlining the process and motivating the sites
• How-to: building a multilevel partnership
Cedric Burg, Deputy Head of Global Clinical Operations, Teva
4.10 Improving risk management
• What are research networks?
• Supporting Delivery
• CRO and sponsorship relationships
• Improving flexibility in an agreement to avoid possible trouble
John Bennett, Director, JABPharma
4.50 Chairman's Closing Remarks and Close of Day One
Managing Partnerships with CROs 2012
Day One | Wednesday 3rd October 2012 www.pharmaoutso
Sponsored by
Biomedical Systems is a global leader in centralized diagnostic
services offering a full suite of services for Cardiac Safety and
Efficacy, Pulmonary Function Testing including Spirometry, Peak
Flow, Nitric Oxide,... and digital Medical Imaging for clinical trials,
from classical imaging modalities as well as centralized EEG, Gait
and Digital Pathology. www.biomedsys.com
Official Media Partner

3. y fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
8.30 Re-registration and Coffee
9.00 Chairman's opening remarks
Albert Agro, President, HNZ-Strategic Holdings
Outsourcing Opportunities
OPENING ADDRESS
9.10 Reactivity of niche CROs in the world of global CRO – pharma
partnerships
• Benefits and drawbacks of functional outsourcing
• Establishing criteria for patient recruitment
• Case study
• The road ahead
Albert Agro, President, HNZ-Strategic Holdings
9.50 The NIHR clinical research network; delivering research in the NHS
• Effective set up and delivery of clinical research
• Supporting CROs to deliver to time and target
• The NIHR – opportunities from translational medicine through to
pharmcovigilence studies
Clare Morgan, Director of Industry, NIHR Clinical Research Network
Coordinating Centre
10.30 Morning Coffee
11.00 The HRA and research
• Opportunities for increasing a relationship
• Long term outlook of the HRA and research
• Combining your talents; both sides can learn from one another
Janet Wisely, Director, HRA Health Research Authority
11.40 How biotech interacts with CROs
• Maintaining flexibility during clinical development
• Selection of CRO
• Dealing with a diverse pipeline
• Resulting into strategic partnership: win – win situations
Malcom Horsley, Consultant, PA Consulting
Mark Eisenecker, Consultant, PA Consulting
12.20 Networking Lunch
Hidden Factors and Modernising Relationships
1.40 Success factors for a strong CRO partnership
• Combining cultures
• What should you look for in a major CRO
- Governance
- Communication
- Therapeutic & Operational expertise
- Quality Assurance and Planning
- Leadership
- Flexibility
• Role of strategic partnerships
Prassad Velisetty, Senior Medical Director, Quintiles
Dominic Bowers, Medical Director, Quintiles
2.40 Clinical Site Contracting in an Outsourcing Environment
• Micro/Macro management ethos and their relationship to the
outsourced site contracting deliverables
• Negotiation Guidelines and Legal Autonomy
• Deliverables, Reporting, Metrics and performance indicators
Gary Reeves, Clinical Contracts Manager, Biogen Idec
3.20 Afternoon Tea
3.50 Interactive Panel Discussion : Outsourcing perspectives from both
sides of the table
Topics Including
• New challenges faced by CROs – Sponsors
• Opportunities for enhancement
• Different business models and costing strategies
Chaired by - Albert Agro, President, HNZ-Strategy
Panelists - Dominic Bowers, Medical Director, Quintiles
Andrew Huxley, Outsourcing Director, Eli Lilly & Co
4.30 Chairman’s Closing Remarks and Close of Day Two
Day Two | Thursday 4th October 2012
ourcingevent.com
SMi's Pharmaceutical Forward Planner 2012
JUNE
11-12 RNAi&Nanotechnology
JULY
2-3 KOLManagementand
MSLBestPracticein
Europe(Switzerland)
9-10 ADMET
9-10 SocialMediainthe
PharmaceuticalIndustry
11-12 BioBanking
SEPTEMBER
17-18 NextGeneration
Sequencing
19-20 CancerVaccines
24-25 Biosimilarsand
Biobetters
26-27 KOLManagement
OCTOBER
3-4 PartnershipswithCROs
8-9 PharmaceuticalOrphan
Drugs
22-23 COPD:Novel
Therapeuticsand
Management
Strategies
24-25 PointofCare
Diagnostics-Market
Opportunitiesand
TechnologyTrends
29-30 European
PharmaceuticalPricing
&Reimbursement
NOVEMBER
5-6 CellBasedAssays
5-6 ClinicalTrialsinCNS
28-29 Diabetes
DECEMBER
3-4 ColdChainDistribution
Allconferencestakeplacein
centralLondon,UK–unless
indicatedotherwiseinbrackets
SPONSORSHIP AND
EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition,
advertising and branding packages,
uniquely tailored to complement your
company’s marketing strategy. Prime
networking opportunities exist to
entertain, enhance and expand your
client base within the context of an
independent discussion specific to your
industry. Should you wish to join the
increasing number of companies
benefiting from sponsoring our
conferences please call: Alia Malick on
+44 (0) 20 7827 6168 or email:
amalick@smi-online.co.uk

4. Overview of workshop
The workshop looks at defining the scope and extent of the
relationship, ensuring the relationship starts off on the right foot,
ensuring quality and compliance and ensuring the necessary
communications for unforeseen activities and demands.
Whyyoushouldattend:
• Analyse how to define the nature of the relationship
• Study multinational multiple product outsourcing of
pharmacovigilance
• Learn what makes a relationship work
• Develop strategies for maintaining quality
• Network with key industry professionals
Programme
8.30 Registration&Coffee
9.00 Welcome&Introductions
9.10 DefiningtheNatureoftheRelationship
• Project and Long term relationships
• Defining Scope and Contract
• Differences between Responsibility and Accountability
9.45 Amulti-national;multipleproductoutsourcingof
pharmacovigilance
• First Steps
• Mapping out the final approach
• Testing the system
• Developing the system
10.45 MorningRefreshments
11.00 Whatmakestherelationshipwork?
• Defining the communication pathways
• Agreeing the formats and data exchanges for data
Quality and Compliance
• Planned and ‘ad-hoc Reviews
• Change Management
12.10 Quality;StandardsandCommunication
• Evolving the system – evolution not revolution
• Regulatory Changes and Planning
• Business Requirements and Contract revisions
12.30 CloseofWorkshop
Abouttheworkshophost
The CEO of PharSafer® is Graeme Ladds who has over 20 years
experience in the Pharma Industry and whose last position in
industry before forming PharSafer® was as Head of Global Drug
Safety for a multi-national Pharma Company and as EU Qualified
Person for Pharmacovigilance (EU QP PV).
Graeme has worked as both a Pharmacovigilance and Medical
Information Manager previously, and over the many years of
working in the field of Safety and Medical Services has written a
modular book on Multi-National Pharmacovigilance (2006, 2010);
written many articles on Pharmacovigilance in peer reviewed
journals; currently serves as editor on a multi-national
Pharmacovigilance Journal; is a regular speaker at conferences;
and active member of many international associations which
include the DIA (and active member of SIAC); TOPRA; and ISOP.
PharSafer® and Graeme Ladds have appeared in the Annual
Who’s Who list of innovative Companies and Directors since 2007.
AboutPharSafer®
PharSafer® aim to be your Global Pharmacovigilance and
Medical Services provider of choice. We have a number of quality,
cost-effective initiatives to help with your Pharmacovigilance and
Medical Services needs. We welcome any questions or queries
you may have concerning our services and are happy to meet with
potential clients to discuss how we can help from simple interim
solutions to full outsourcing.
In association with
HALF-DAY PRE-CONFERENCE AM WORKSHOP
Tuesday 2nd October 2012
8.30am – 12.30pm
Holiday Inn Bloomsbury, London, UK
A:CollaborationswithCROs
–Touch-pointsforSuccess
Workshop Leader:
GraemeLadds,Director, PharSafer
PharSafer

5. Overview of workshop
Pharmaceuticalindustryisincreasinglychallengedtoimprove
R&D productivity. Focus on core capabilities in line with
strategic outsourcing represents one important lever that is
currently explored. As scope and intensity of pharma – CRO –
partnershipsincrease,newpartnermodelsareemerging.For
the new engagement types both parties still need to optimise
how they work together. One focus area here is the
mechanism required to ensure high quality and
comprehensive deliverables in time.
Whyyoushouldattend
• Learnhow to prepare for partnership
• Utilise the results of post project meetings
• Improve your understanding of building relationships
• Network with key industry professionals
Programme
1.30 Registration&Coffee
2.00 Welcome&Introductions
2.10 RecentTrends&ImplicationsforBothPlayer
• Project and Long term relationships
• Defining scope and contract
2.50 DistinctEngagementModels& SuccessFactors
• First Steps
• Developing a tested system
3.30 AfternoonTea
4.00 ManagingQualityoftheEngagement
• Defining the pathways for good communication
• Developing the new systems
4.40 ConclusionsandFurtherOutlook
• Changing with the times
• Review of lessons to be learnt
5.30 CloseofWorkshop
Abouttheworkshophost
Volker Rönicke is a Vice President in the
Munich Office of Booz & Company. He is a
member of the global healthcare team and
hasmorethan15yearsofcombinedworkand
consulting experience in the pharmaceutical /
biotech industry. He mainly focussed on topics
along the sntire R&D value chain and innovative
commercialisation strategies. For many years he has had the
opertunity to develop, pilot and refine R&D effectiveness and
partneringapproachestogetherwithleadingpharma/biotech
players. Volker Rönicke earned a PhD in Molecular and Cell
BiologyfromMax-Plank–SocietyandMarburgUniversityand
an MBA at Heriot-Watt University, Edinburgh.
AboutBooz&Co
Booz & Comapny is a leading global consulting firm, helping
the worlds top businesses, governments and organisations.
With more than 3,000 people in 60 offices around the world,
Booz works closely with its clients to create and deliver
essential advantage. www.booz.com
In association with
HALF-DAY PRE-CONFERENCE AM WORKSHOP
Tuesday 2nd October 2012
1.30pm – 5.30pm
Holiday Inn Bloomsbury, London, UK
B:Partnershipsbetween
PharmaceuticalCompaniesandCROs
Workshop Leader:
VolkerRonicke,Vice President, Booz&Co
PeterBehner,Consultant, Booz&Co

6. MANAGING PARTNERSHIPS WITH CROS
Conference:Wednesday3rdandThursday4thOctober2012,HolidayInnBloomsbury,London, UK Workshops:Tuesday2ndOctober2012,HolidayInnBloomsbury, London,UK
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