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Organized by: Embed the compliance process throughout your corporate culture Balance 404 responsibilities between management and internal audit Mechanize the identification, assessment and measurement of key business risks Ensure corporate governance throughout the pharmaceutical supply chain Leverage SOX work for valuable applications outside of finance Utilize increased transparency for better business decisions DISTINGUISHED FACULTY INCLUDES: Conference Chairman: John D. Rhodes, U.S. & Global Managing Partner, Life Sciences, Deloitte & Touche LLP Eleanor Bloxham, Founder and President, The Value Alliance and Corporate Governance Alliance Greg Buccarelli, Director of Sarbanes-Oxley, Novartis Colleen Cunningham, President and Chief Executive Officer, Financial Executives International Hugh Donnelly, Vice President of Corporate Internal Audit, Pfizer Inc Arnie Hanish, Chief Accounting Officer, Eli Lilly & Co Anna M. Seal, Senior Vice President, Chief Financial Officer, GlaxoSmithKline Global Manufacturing and Supply Andre Van Hoek, Director, Financial Compliance and Procedures, Johnson & Johnson 5LEADING PHARMACEUTICAL COMPANIES ILLUSTRATE HOW TO: SEPTEMBER 26-27, 2005 • THE HYATT REGENCY • PRINCETON, NJ Outstanding Support Provided by: REGISTER BY JULY 22,2005 AND SAVE $500 OFF YOUR REGISTRATION FEE! Strategic Corporate Sponsor: Executive Sponsors: CHOOSE FROM TWO PRE-CONFERENCE WORKSHOPS — MONDAY, SEPTEMBER 26, 2005 A. MD&A Reporting Requirements and Best Practices B. Integrating 404 Compliance with IT Infrastructures Co-Sponsored by: Achieve Compliance,Derive Long-Term Value and Reduce Costs from SOX-Related Activities CBI, IN ASSOCIATION WITH DELOITTE & TOUCHE USA LLP, PRESENTS: Strategic Partner: FEATURING AN SEC/FDA CO-KEYNOTE ADDRESS ON: Compliance and Accountability in Today’s Pharmaceutical Industry Update on the latest enforcement activity and SEC “hot button” issues Cooperation between the SEC and the FDA Arthur S. Gabinet, District Administrator, Philadelphia Office, The U.S. Securities and Exchange Commission Steve Silverman, Director of the Division of New Drugs and Labeling Compliance, The Food and Drug Administration THE PHARMACEUTICAL CONFERENCE ON SUSTAINING The Center for Business Intelligence is registered with the National Association of State Boards of Accountancy as a sponsor of continuing professional education on the National Registry of CPE Sponsors.

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Page 1: THE PHARMACEUTICAL CONFERENCE ON SUSTAINING · THE PHARMACEUTICAL CONFERENCE ON SUSTAINING The Center for Business Intelligence is registered with the National Association of State

Organized by:

Embed the compliance process throughout your corporate culture

Balance 404 responsibilities between management and internal audit

Mechanize the identification, assessment and measurement of key business risks

Ensure corporate governance throughout the pharmaceuticalsupply chain

Leverage SOX work for valuable applications outside of finance

Utilize increased transparency for better business decisions DISTINGUISHED FACULTY INCLUDES:

Conference Chairman:John D. Rhodes, U.S. & Global Managing Partner,Life Sciences, Deloitte & Touche LLP

Eleanor Bloxham,Founder and President, The Value Alliance and Corporate Governance Alliance

Greg Buccarelli, Director of Sarbanes-Oxley, Novartis

Colleen Cunningham, President and Chief Executive Officer, Financial Executives International

Hugh Donnelly,Vice President of Corporate Internal Audit,Pfizer Inc

Arnie Hanish, Chief Accounting Officer, Eli Lilly & Co

Anna M. Seal, Senior Vice President, Chief Financial Officer, GlaxoSmithKline Global Manufacturing and Supply

Andre Van Hoek, Director, Financial Compliance and Procedures, Johnson & Johnson

5 LEADING PHARMACEUTICAL COMPANIES ILLUSTRATE HOW TO:

S E P T E M B E R 2 6 - 2 7 , 2 0 0 5 • T H E H Y A T T R E G E N C Y • P R I N C E T O N , N J

Outstanding Support Provided by:

REGISTER BY JULY 22, 2005 AND SAVE $500 OFF YOUR REGISTRATION FEE!

Strategic Corporate Sponsor: Executive Sponsors:

CHOOSE FROM TWO PRE-CONFERENCE WORKSHOPS — MONDAY, SEPTEMBER 26, 2005

A. MD&A ReportingRequirements and Best Practices

B. Integrating 404 Compliance with IT Infrastructures

Co-Sponsored by:

Achieve Compliance, Derive Long-Term Value and Reduce Costs from SOX-Related Activities

CBI, IN ASSOCIATION WITH DELOITTE & TOUCHE USA LLP, PRESENTS:

Strategic Partner:

FEATURING AN SEC/FDA CO-KEYNOTE ADDRESS ON:

Compliance and Accountability in Today’s Pharmaceutical Industry

• Update on the latest enforcement activity and SEC “hot button” issues

• Cooperation between the SEC and the FDA

Arthur S. Gabinet, District Administrator,Philadelphia Office, The U.S. Securities and Exchange Commission

Steve Silverman, Director of the Division of New Drugs and Labeling Compliance, The Food and Drug Administration

THE PHARMACEUTICAL CONFERENCE ON SUSTAINING

The Center for Business Intelligence is registered with the National Association of StateBoards of Accountancy as a sponsor of continuing professional education on the NationalRegistry of CPE Sponsors.

Page 2: THE PHARMACEUTICAL CONFERENCE ON SUSTAINING · THE PHARMACEUTICAL CONFERENCE ON SUSTAINING The Center for Business Intelligence is registered with the National Association of State

To Register Call Toll Free 800-817-8601 (781-939-2438 outside the U.

C h o o s e f r o m T w o P r e - C o n f e r e n c e W o r k

MD&A Reporting Requirements and Best Practices

One of management’s most important responsibilities includes clear and straightforward communication with investors.MD&A (Management’s Discussion and Analysis) is a critical component of that communication. However, this analysis of financial condition and this report on the results of operations is a challenge to many financial executives. And while the communication in the MD&A needs to be straightforward and meaningful, it seems that the requirements of what isincluded and excluded are not clear-cut. This in-depth workshop delves into the SEC requirements of MD&A, shares the best practices of MD&A preparation and reviews industry-specific models to guide you in your financial reporting endeavors.

A

7:30 Workshop Registration and Continental Breakfast

8:30 Workshop Leaders’Welcome and Opening Remarks

I. Is Your MD&A Meeting the SEC's Expectations?• Does it enable investors to view the company

“through the eyes of management”?

• Does it provide context for analysis of the company’sfinancial information?

• Does it inform readers about the quality and potentialvariability of a company’s earnings and cash flows?

II. Responding to New Requirements and Recent Guidance

• Format and clarity of presentation

• Need for focus on key information and analysis

• Improvement of liquidity and capital resources section

• Disclosure of critical accounting estimates andassumptions made by management

III. Focus and Content — What Must Be Includedand What Should Be Omitted

• Presentation — What is included in the introduction and overview

• Identification of key information, variables,indicators and analyses

• Need for focus on key information and analysis

• Avoiding duplication and focusing on materiality

• Providing material trends and uncertainties/analysis

• Information on liquidity and capital resources

• Disclosure of critical accounting estimates

• Crafting the conclusion

• Use of the “forward-looking statement” safe harbor

IV. Recent Developments and Areas of SEC Focus• “Hot-button” issues to be aware of

• Litigation developments, and how to draft a responseto them

12:00 Close of Workshop

There will be a 30-minute networking and refreshment break at 10:00 am

— ABOUT YOUR WORKSHOP LEADERS —

Chris Barry is a Partner in the law firm of Dorsey & WhitneyLLP, dividing his time between the firm's Seattle and Torontooffices. He has almost 30 years of experience in corporatefinance, mergers and acquisitions, securities law compliance andcorporate governance and general business counseling. He hasacted as lead counsel in a broad variety of complex acquisitionand financing transactions and is internationally recognized forhis expertise in structuring and completing cross-borderacquisitions and financings. He has served as a legal advisor andcounselor to both U.S. and non-U.S. companies, assisting them in managing their general legal affairs, regulatory compliance and corporate governance and long-term strategic planning.

Nanci Prado is a Senior Corporate Associate in the New Yorkoffice of the law firm of Dorsey & Whitney LLP. Sherepresents public and private companies, investment banks andventure capital firms in SEC-registered public offerings and inprivate placements, venture capital financings, mergers andacquisitions, corporate governance and SEC reporting andcompliance. She has extensive experience advising public andprivate companies in the life sciences industries, as well as other technology companies. Her experience also includesrepresenting non-U.S. companies and underwriters in public and private securities offerings in the United States.

2

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Integrating 404 Compliance with IT Infrastructures

Sarbanes-Oxley does not explicitly regulate technology, however technology can greatly reduce the cost, time and risk of

a company’s compliance activities. The purpose of SOX is to improve the transparency and accountability of business

processes related to reporting, and technology is most often the infrastructure behind these business processes. This

workshop is for IT professionals to explore practical ways for IT to sustain a compliant infrastructure through automation.

B

7:30 Workshop Registration and Continental Breakfast

8:30 Workshop Leaders’Welcome and Opening Remarks

I. PCAOB and SEC Guidance• Top down risk approach• Development of risk matrices• Use of monitoring controls and “self-assessments”

II. Assess the Current Adequacy of IT Systems• What are the diagnostic questions to assess the

adequacy of IT controls for Sarbanes-Oxley?• Will the current system support reliance

financial processing?

III. Embed Automated Infrastructure Controls• Streamlining infrastructure• Monitoring and tracking tools

IV. Automated Application Controls• Assessment of manual vs. automated controls.• Importance of segregation of duties

V. Identify Vulnerable Areas• Perform and detail the self-assessment process• Assess the appropriateness of the self-assessment tests • Review changes and revisions to the control

environment or new applications • Deal with exceptions

VI. Structure an Action Plan to Achieve Compliance• Sort, summarize and report key findings• Communicate and educate the end-user

VII. Case Studies

12:00 Close of Workshop

There will be a 30-minute networking and refreshment break at 10:00 am

— ABOUT YOUR WORKSHOP LEADERS —

David P. Ross is a Managing Director in Protiviti’s TechnologyRisk Consulting practice. He is the co-chair of Protiviti’snational Healthcare and Life Sciences industry practice. Prior toProtiviti, Mr. Ross spent was part of Andersen’s Metro NewYork Technology Risk Consulting practice with responsibilityfor providing services to the Healthcare and Pharmaceuticalindustries. He has participated or is participating in a number ofprojects with pharmaceutical and biotech and other healthcarecompanies, including managing the out-sourcing of internal auditat a major generic pharmaceutical manufacturer, the co-sourcingof internal information technology (IT) audit function for aworldwide pharmaceutical and consumer products company and a major hospital system. He has participated in the businesscontinuity planning for a major pharmaceutical manufacturer and for a biotechnology company. Mr. Ross is a member ofProtiviti’s network of Sarbanes-Oxley Act Champions.

Mike C. Brennan is a Senior Manager with Protiviti. Prior tojoining the Company, Mr. Brennan was a Manager of InternalAudit Services Group for The Cohn Consulting Group, adivision of J.H. Cohn LLP. He previously served as VicePresident and Director of Internal Audit of ORIX USACorporation, a diversified financial services organization. He also served as Vice President and Financial Audit Manager for Summit Bancorp. Mr. Brennan worked with a number ofDecember 31st Sarbanes-Oxley filers. He helped developdocumentation of the client’s internal control activities, RiskControl matrix and Test Plans and executed preliminary and finaltesting of internal control activities (Clients were in the LifeSciences and Financial Services Industries). Mr. Brennan workedwith a Financial Services Organization on the development andimplementation of a control self assessment process for a branchnetwork consisting of 300 locations and for a Consumer LoanServicing Center. He is a Certified Public Accountant (“CPA”), aCertified Financial Services Auditor (“CFSA”) and a CertifiedBank Auditor (“CBA”).

s h o p s — M o n d a y , S e p t e m b e r 2 6 , 2 0 0 5

S.) or Fax 781-939-2490. Register on our website at www.cbinet.com 3

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MAIN CONFERENCE

Day One — Monday, September 26, 2005

12:00 Main Conference Registration

1:00 Chairman’s Welcome and Opening RemarksJohn D. Rhodes, U.S. & Global Managing Partner, Life Sciences,Deloitte & Touche LLP As the U.S. & Global Managing Partner of Deloitte’s Life Sciences practice,Mr. Rhodes is responsible for the Firm’s services to pharmaceutical,biotechnology and medical products companies. Mr. Rhodes has more thantwenty years of experience working with pharmaceutical, biotech, medicalproducts and manufacturing industries focusing on accounting and auditing,SEC reporting, business process and contracting issues, corporatecompliance, strategic alliances, research and promotion collaborations, jointventure formations and mergers and acquisitions. Mr. Rhodes has served inthe Firm’s National Office Accounting Consultation Group and currentlyconsults on accounting and SEC issues affecting the Life Sciences industry.He has also served as a member of the Firm’s Senior Partner LegacyProgram Committee and the AICPA Expert Roundtable onPharmaceuticals and Biotechnology, as well as participated in the U.S.Government Office of Management & Budget, Research & DevelopmentCosts Classification Study. He has been published in PharmaceuticalExecutive, BioIT World, BioPharm International, Med Ad News, The WallStreet Transcript, R&D Directions and the Life Sciences section of theFirm’s Questions at Stockholders’ Meetings. He is frequently interviewed byindustry publications and chairs and participates on both U.S. andinternational panel sessions dealing with industry issues.

1:15 SEC and FDA Perspective on Compliance and Accountability in Today’s Pharmaceutical IndustryThe pharmaceutical industry has been subject to varioussubpoenas, lawsuits and regulatory action over the pastfew years, spurring an increased interest and heightenedaccountability for corporate compliance and accuratereporting practices. Recent public scrutiny has broughtcompliance and accountability for the pharmaceuticalsector to the forefront. This keynote address provides an opportunity to hear from the U.S. Securities andExchange Commission and from the U.S. Food and DrugAdministration on some of the most critical complianceissues related to the pharmaceutical industry today.Topics addressed include:

• Update on the latest enforcement activity and SEC“hot button” issues

• Disclosure issues• Cooperation between the SEC and the FDA• SEC Corporation Finance update —

Comment letters and hot topics• Critical compliance issues for 2005-2006

Arthur S. Gabinet, District Administrator, Philadelphia Office, The U.S. Securities and Exchange Commission Mr. Gabinet is the director of the SEC’s Philadelphia Office, responsible for the Commission’s Examination and Enforcement programs in an areacomprising Pennsylvania, Delaware, Maryland, Virginia, West Virginia andthe District of Columbia. Mr. Gabinet has overseen a number of highprofile cases for the Commission, including the Commission’s attack onundisclosed revenue sharing and directed brokerage payments, notably therevenue sharing and mutual fund share class cases against Morgan StanleyDW and Citigroup Global Markets (brought jointly with NASD), theCommission’s directed brokerage cases against mutual fund giants MFS andPIMCO and the Commission’s $250 million market timing suits againstHarold Baxter, Gary Pilgrim and the PBHG funds. Prior to joining theCommission in January 2003, Mr. Gabinet was a litigation partner withDechert LLP, where he specialized in securities and complex commerciallitigation. He has written on a number of subjects, including private causesof action under the Investment Company Act and director exculpationclauses in the bankruptcy context.

Steve Silverman, Director of the Division of New Drugs and Labeling Compliance, The Food and Drug Administration Mr. Silverman is the Director of the Division of New Drugs and LabelingCompliance in the FDA’s Center for Drug Evaluation and Research, Office of Compliance. The Division works primarily to ensure compliancewith the new drug, misbranding and adulteration provisions of the Federal Food, Drug and Cosmetic Act governing over-the-counter andprescription drugs. Issues within the Division’s portfolio includeunapproved drugs, drug compounding, import and export matters andInternet and health fraud. Before joining the Division, Mr. Silvermanserved as an Associate Chief Counsel in FDA’s Office of Chief Counsel,where he focused on dietary supplement enforcement. Mr. Silverman’sgovernment service includes four-plus years as a trial attorney with theU.S. Department of Justice’s Tax Division, which he joined following his tenure with the Federal Trade Commissions Financial PracticesDivision. He began his career in private practice with the Washington,D.C., law firm of Wiley, Rein & Fielding.

Optimize Organizational Structure and Business Processes for Compliance

2:00 Advance from Sarbanes PMO to ProcessManagement for Long-Term Value Corporate governance, SOX activities and 404 assessmentsneed to be ingrained in every public company. Advancingfrom a project mindset to a process management approachwill enable cost-effective sustainability for the long-term.This session discusses how to make the transition and howto master the process of SOX sustainability.

• Change management for embedding value in the business

• Organize and prioritize the compliance process• Educate and motivate employees to support the

corporate governance efforts and internal controls• Avoid complexities when possible• Integrate the functions and departments that

contribute to compliance and reportingDavid Hodgson, Partner, Enterprise Risk Services, Deloitte & Touche

To Register Call Toll Free 800-817-8601 (781-939-2438 outside the U.

Compliance costs for Section 404 have mounted to more than $Attend this unique forum to hear cost-effective com

SEC/FDA CO-KEYNOTE ADDRESS

4

Page 5: THE PHARMACEUTICAL CONFERENCE ON SUSTAINING · THE PHARMACEUTICAL CONFERENCE ON SUSTAINING The Center for Business Intelligence is registered with the National Association of State

Mr. Hodgson has over twenty-five years of broad-based experience inauditing and consulting. His primary focus is on assisting largeorganizations improve internal controls by implementing effective riskmanagement strategies. Over the last two years, Mr. Hodgson hasspecialized in Sarbanes-Oxley Section 404, and has led our firm’s efforts toassist two major multinational pharmaceutical companies with theirSarbanes-Oxley Section 404 readiness activities. He has hands-onexperience in applying 404 in the pharmaceuticals industry, includinginitial scoping and communications, customizing a 404 process,customizing and implementing supporting technology, training business unitpersonnel and summarizing and reporting on results, including remediationactivities. His pharmaceutical clients include Bristol Myers-Squibb, EliLilly, Johnson & Johnson, Merck, Pfizer and Pharmacia Corporation. Heis a member of the American Institute of Certified Public Accountants, theAssociation of Chartered Accountants in England and Wales, the BritishAmerican Chamber of Commerce and a past member of the Board ofResearch Advisors of The Institute of Internal Auditors.

2:40 Networking and Refreshment Break

3:10 The Role of Internal Audit in Section 404 Sustainability As the pharmaceutical industry and healthcareenvironment continue to change, compliance efforts and internal controls must be continually revisited and reevaluated. How should you be optimizing the role ofoutside and internal auditors so that your complianceefforts are seamless and effectual? This presentationaddresses the following topics:

• Developing policies and assessing the adequacy ofcurrent controls

• Balancing section 404 responsibilities betweenmanagement and internal audit group — How this impacts external audit

• Internal review with audit committee

• Effective communications and dealings withindependent auditors and outside counsel

• Audit committee responsibilities and boardleadership in effective corporate governance

• Deriving long-term value from 404 compliance activities

Arnie Hanish, Chief Accounting Officer, Eli Lilly & Co. Mr. Hanish joined Eli Lilly and Company as manager of domestic taxoperations in 1984. In 1987, he moved into a financial reporting role andwas appointed Chief Accounting Oofficer in 1994. He is currently ExecutiveDirector of Finance and Chief Accounting Officer. Mr. Hanish is responsiblefor the global accounting process as well as the U.S. payroll, shareholder andstock option services and business partner support for corporate stafffunctions. Prior to joining Lilly, Mr. Hanish was with Arthur Young &Company (currently Ernst & Young) for nearly 14 year in several capacities,the last of which was director of tax in the firm’s Indianapolis office. Mr. Hanish served on the board of trustees of the Indiana CPA EducationFoundation. From 1999 to 2001, he served on an AICPA Task Force that

resulted in the publication of a white paper on “Accounting for In-processResearch and Development Expenses”. He is currently vice-chairperson ofthe Financial Executive’s International Committee on Corporate Reporting.He also serves on the FEI-SEC and FEI-PCAOB subcommittees. Mr.Hanish was recently appointed to a three-year term as a member of theStanding Advisory Group of the PCAOB.

3:50 A Report on the Compliance Practices of LeadingCompanies for Key Aspects of 404 SustainabilityAlthough many aspects of the Sarbanes-Oxley Act directlyimpact financial executives, none caused more effort andcosts than Section 404. While efforts to comply with 404have provided some valuable insights, the time,redeployment of people and other costs associated with theinitial implementation is not sustainable. Evaluating theresults and leading practices of first year implementation iscritical to achieving long-term success. This sessiondescribes the compliance practices of leading companiesfor a number of critical aspects of Section 404, including:

• Organization structure• Scope, documentation and testing• IT controls• Use of external resources• Relationship with the auditor• Deficiency management• Audit committee communications• Section 302/304 certification process• Management letter and reporting• Unintended consequences of 404 implementation

Colleen Cunningham, President and Chief Executive Officer, Financial Executives InternationalMs. Cunningham was named President and Chief Executive Officer ofFinancial Executives International (FEI) in March of 2003. FEI is theprofessional association of choice for senior-level corporate financialexecutives and the leading organization dedicated to advancing ethical,responsible financial management. Prior to joining FEI, Ms. Cunninghamserved as Senior Vice President and Chief Financial Officer, North America,of Havas Advertising (NASDAQ: HAVS), the fifth largest advertisingholding company in the world. At Havas, Ms. Cunningham was responsiblefor North American financial operations, including tax, controller andtreasury functions, SEC and U.S. GAAP reporting and worldwideaccounting policies, as well as establishing and staffing the company’sNorth American headquarters. She began her career in public accountingwith the firms formerly known as Touche Ross and Coopers & Lybrand.She then spent thirteen years with AT&T as Assistant Controller of AT&TCapital during a period of enormous growth, and later as Vice Presidentand Chief Accountant at AT&T Corporate. A member of FEI since 2000,Ms. Cunningham was named one of the top 100 influential people infinance by Treasury & Risk Management magazine and one of the top 100 influential people in accounting by Accounting Today.She is also a member of FASAC and IASAC.

4:30 Networking and Refreshment Break

BenchmarkingSession

S.) or Fax 781-939-2490. Register on our website at www.cbinet.com 5

35 billion, 20 times higher than regulators originally estimated.pliance strategies from your industry counterparts.

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5:00 Leverage Internal Audit for a ComprehensiveRisk Management PlanEnterprise Risk Management has evolved from ‘nice tohave’ to ‘must have’ as regulators have recognized the vast array of risks facing large global organizations and responded with new requirements for Boards andAudit Committees. Internal Audit is well-positionedto coordinate Risk Management plans within thepharmaceutical industry in part due to the nature of risk assessments and monitoring already with its scope,and in part due to existing Board and Audit Committeerelationships. A comprehensive internal audit andcompliance program requires the seamless integration and collaboration between a number of critical functionswithin a pharmaceutical manufacturer including InternalAudit, Enterprise Risk Management, Legal, Complianceand Financial Reporting. In this session, Pfizer illustratesbest practices in the area of internal audit and riskmanagement. Learn how to:

• Align business strategy with enterprise risk management

• Create a sound annual audit plan • Maintain the roles and responsibilities of key

constituents in the process — The board, seniormanagement, risk owners and internal auditors

• Create an organized mechanism for how all keybusiness risks are identified, assessed, analyzed and measured

• Evaluate and prioritize areas of potential risk • Work with the legal function to execute a risk

management strategy• Establish and manage a compliance hotline• Leverage already performed Sarbanes work to

mitigate business riskHugh Donnelly, Vice President of Corporate Internal Audit, Pfizer IncMr. Donnelly is Vice President of Audit at Pfizer Inc. He assumed thisposition in July, 2002 and is responsible for leading internal audit servicesfor Pfizer. Prior to this, he was Assistant Corporate Controller withresponsibility for Pfizer’s North American Shared Services operation and ITsupport for financial applications. During this period, he designed theEuropean Financial Shared Services capability now under construction inIreland. Hugh has held numerous other positions in operations andcorporate finance over a twenty-five year career in the pharmaceuticalindustry. He is a CPA who started his career with Coopers & Lybrand.

5:40 Sustaining Corporate Governance andCultivating Employee Allegiance to the Doctrineof Corporate Governance and Internal ControlsCorporate governance does not only reside in the top tiersof an organization. Corporate governance, to be successfuland valuable, must cultivate from within an organizationand it must be a doctrine understood and practices by eachand every employee. This session provided guidance onthe following key concepts:

• Building trust throughout the fabric of the organization

• Moving beyond compliance to creating value• Continually evolving governance practices• Promoting open communications • Encouraging corporate ethics

• Aligning employee interests with the goal ofcompliance to maximize value

• Creating long-term value for investors, managers,employees and other stakeholders

Eleanor Bloxham, Founder and President, The Value Alliance and Corporate Governance Alliance Ms. Bloxham is the Founder and President of The Value Alliance andCorporate Governance Alliance, and she is a former KPMG NationalDirector and Practice Leader. She is recognized as a pioneer in the area ofEconomic Value Management and an expert on corporate governance. Ms. Bloxham is an advisor to organizations, their CEOs and Boardmembers, and she has provided advisory services to major global firms aswell as small start-up companies. Ms. Bloxham is a frequently quoted expertin the financial, national and international press (including, among others,CNN’s Moneyline with Lou Dobbs, National Public Radio, CFO Europe,Business Week, USA Today, the New York Times, Board Alert, ComplianceWeek and The Wall Street Journal where her expertise and work have beencited) on the subjects of corporate governance, performance and value. She is the author of over 30 articles and is the author of two books (Value-led Organizations and Economic Value Management: Applications andTechniques) published by John Wiley and Sons. She is also the publisher ofThe Corporate Governance Alliance Digest. Prior to her consulting career,Ms. Bloxham spent nearly twenty years in financial services encompassingbanking, investments and insurance, holding executive positions atPrudential Financial Services and at Bank One. She has been selected asone of “12 Women You Should Know” in 2005 by the Women’s Economic andLeadership Development Organization.

6:20 Close of Day One

Day Two — Tuesday, September 27, 2005

7:30 Continental Breakfast

8:00 Chairman’s Review of Day One John D. Rhodes, U.S. & Global Managing Partner, Life Sciences, Deloitte & Touche LLP

Strategies and Processes for Compliant Financial Reporting

8:15 Compliance with Sarbanes-Oxley through Risk-Based Management in the PharmaceuticalSupply Chain and Distribution ProcessThe supply and distribution of pharmaceutical products isan extremely complex network, involving numerousstakeholders across the globe. The long-reach ofSarbanes-Oxley extends well into the supply chain anddistribution processes, creating a number of multifacetedchallenges for pharmaceutical financial executives. This session shares lessons learned and best practices formanaging the corporate governance of the pharmaceuticalsupply chain. Topics addressed include:

6:20-7:20 Networking Cocktail Reception

Hosted by:

BestPractices

To Register Call Toll Free 800-817-8601 (781-939-2438 outside the U.S.) or Fax 781-939-2490. Register on our website at www.cbinet.com6

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• Implementing a risk-based management processthroughout the pharmaceutical supply chain

• Managing a number of products, brands, dosageforms and sku numbers to ensure compliance

• Documenting controls put in place across diverse anddisparate facilities across the world

• Dealing with different cultures to ensure robustcontrols throughout a global distribution network

• Strengthening the end-to-end integrity of your supply chain

Anna M. Seal, Senior Vice President, Chief Financial Officer,GlaxoSmithKline Global Manufacturing and Supply Ms. Seal is the Chief Financial Officer of GlaxoSmithkline’s GlobalManufacturing and Supply Division for the Pharmaceuticals and ConsumerHealthcare businesses. In this capacity, she has responsibilities in;Financial Management, Planning, Budgeting and Reporting, ComplianceOfficer for Sarbanes-Oxley implementation, Strategic Planning and SupplyChain Restructuring, Product Supply and Sourcing Strategies, CorporateCapital Board and the Lean and Six Sigma Improvement Program. Ms. Sealwas formerly the Chief Financial Officer of Smithkline Beecham WorldwideSupply Operations, Chief Financial Officer / Chief Information Officer ofSmithkline Beecham Animal Health Division, Smithkline Beecham ChiefAuditor, General Manager and Area Vice President of Smithkline BeechamLatin America Operations.

9:00 Strategies for Reducing Reporting Complexityto Improve SOX ComplianceNow that companies are advancing from year one ofimplementation to year two of sustainability of SOX and404 compliance, how can the overall financial reportingprocess be simplified to make it more manageable? Whatare some of the lessons learned from year one that can beapplied in year two to reduce unnecessary work, resourcesand complexities with the overall process? This sessionprovides key insights for better managing the financefunction in your business and provides guidance forsimplifying key elements of the process, including:

• Reporting processes and procedures• Systems necessary for streamlined financial reporting• Structures that improve the overall closing and

consolidation processGary Apanaschik, Pharmaceutical Industry Finance Effectiveness Leader, Partner, PricewaterhouseCoopers Gary Apanaschik is a Partner in PwC’s Finance Effectiveness practice. He specializes in the design and implementation of financial processes,systems and best practices. He has over 22 years of consulting experiencefocused on improving finance process flows, structures and systems.Mr. Apanaschik’s consulting clients have included Pfizer, Schering Plough,Iron Mountain, Stanley Works, Hartford Life, Northeast Utilities and General Electric. He has assisted numerous finance organizations alignstructures, process and systems to support customer needs and changingbusiness strategies. He has worked with finance organizations on metricsdevelopment, budgeting and forecasting improvement, shared services andoutsourcing, closing and consolidation improvement and implementationand optimization of leading finance tools and systems.

9:45 Derive Long-Term Business Value fromCompliance Activities and InvestmentsPublic companies are paying tremendous amounts ofmoney and are dedicating tremendous resources in order tostay compliant with Sarbanes-Oxley. Compliance costs forSection 404 have mounted to more than $35 billion, whichis 20 times higher than regulators originally estimated.

According to recent AMR Research, software sales for

SOX-aimed programs will jump 52% this year. With all ofthe money invested in SOX compliance, it is critical foryour organization to maximize this investment for long-term business value.

• Leverage SOX activities for other businessapplications outside of the finance function

• Utilize the increased transparency for more adeptbusiness decisions (i.e. contracting, licensing, etc…)

• Advance your organization to enterprise-widebusiness process optimization

• Streamlining processes to achieve automation in SOX activities

Greg Buccarelli, Director of Sarbanes-Oxley, NovartisMr. Buccarelli is the Director of Corporate Financial Compliance atNovartis Pharmaceuticals and he has his CPA certification and an M.B.A. in Finance. He has 25 years professional experience in Finance,including Financial Systems. His experience includes the Electronics, Oil and Pharmaceutical industries. His recent work includes the Sarbanes-Oxley implementation and it's successful attestation for global Novartis, a 12/31/04 filer, with current efforts on bringing this to a more effective and efficient compliance effort.

10:30 Networking and Refreshment Break

11:00 Sustaining Sarbanes-Oxley 404 ComplianceAcross a Global, Decentralized OrganizationThis session discusses the implementation andmaintenance of the Sarbanes-Oxley 404 requirements in a broadly based, global and decentralized organization.Learn how to evolve from a project approach to a long-term sustainable process in a global organization.Key elements of the presentation include:

• How to determine worldwide scope

• Develop a consistent approach that can be appliedacross the organization

• Training and education

• Use of technology

• Reporting best practices

• Lessons learnedAndre Van Hoek, Director, Financial Compliance and Procedures,Johnson & JohnsonMr. Van Hoek became the Director of Financial Compliance andProcedures for Johnson & Johnson [J&J] in 2000. He joined J&J in1984 at Janssen Pharmaceutica in Belgium and has worked in variousfinancial positions and geographical locations for J&J during his 20 yearswith the Corporation. Prior to joining J&J, Andre was an Audit Managerat Touche, Ross International [now DTT]. He is a graduate of theUniversity of Antwerp and has been an active member in severalorganizations including the following: President of the Benelux Chapterof the Institute of Internal Auditors (IIA) (1994-1995); Member of theInternal Auditing Standards Board of IIA Worldwide (1990-1996); andBoard Member of the European Confederation of the IIA (1994-1995).He became a Certified Public Accountant in Belgium and a CertifiedInternal Auditor. He is also a member of the Accounting Advisory Boardof the Rutgers Business School.

Case Study

7S.) or Fax 781-939-2490. Register on our website at www.cbinet.com

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Solutions for Automating the Financial Reporting Process

11:45 Automate and Sustain Sarbanes-OxleyCompliance through Effective Application of TechnologyThe cost, complexity and risk associated with highlymanual and ad hoc approaches to Sarbanes-Oxleyintroduce unacceptable risk and unjustified expense. As enforcement rigor and best practices become morebroadly understood within corporations, the application of technology to reduce cost, improve defensibility andincrease automation has become an essential step inbuilding a sustained approach to Sarbanes Oxleycompliance. This presentation introduces essentialcharacteristics of a sustainable compliance framework and equips attendees with a clear value proposition forapplying technology, criteria to validate proposals and a short list of risks to avoid. Attendees gain:

• Minimum requirements for a sustained compliancemanagement solution

• Guidelines for a total cost of ownership forcompliance applications

• Best practices for balancing near-term deadlines with the need for a sustained long-term approach

• Strategies for integrating compliance with effectivebusiness performance management

• Suggestions on how to get the most out of your CIO

Sebastian Holst, Vice President, Marketing, AxentisMr. Holst is currently the Vice President of Marketing for Axentis, Inc.and he is responsible for product management, marketing andcommunications. In addition to his full time focus on governance, risk and compliance issues, Sebastian has also served as an industryanalyst and as a senior editor for the Gilbane Report. In this capacity,he has published numerous white papers and articles on topics fromtechnology best practices in the pharmaceutical industry to virtualrepositories. He currently sits on the boards of IDEAlliance, a non-profit standards organization dedicated to advancing cross-industrytechnology solutions for all content-driven enterprises and TheCompliance Consortium, a non-profit organization designed to promote effective enterprise governance, risk and compliancemanagement. Sebastian was a member of the W3C advisory committeefor five years and has been developing enterprise database, contentmanagement, XML and business intelligence technologies andstandards for over 15 years.

12:30 Luncheon Hosted by:

1:45 Leverage Software Tools to Ease the Burden ofInternal Control AssessmentAmong other arduous tasks, Section 404 requires theidentification of key business process, the controlsoverriding the processes and any vulnerabilities in thesecontrols. Learn how technology and refined softwaresolutions can help you to:

• Benchmark current controls against compliance best practices

• Strengthen identified weaknesses

• Segregate duties

• Document policies and procedures

• Create electronic archives of policies

• Flag suspicious internal transactionsWilliam A. Goebel, Vice President of Operations, GroupERM, A Unit of CimQuest, Inc. Mr. Goebel is an experienced quality assurance professional and facilitator,and he has over twenty years experience in manufacturing, construction andnuclear plant operations. At CimQuest, he has been focused on developmentof audit programs, auditor training, root cause analysis, deficiency trendingand team building. Mr. Goebel joined CimQuest from PECO Energy,Philadelphia, PA. Earlier, he served in a variety of quality assurance andquality management positions at Bechtel Power Corporation, in SanFrancisco, CA and at Electric Boat, in Quonset Point, RI. Mr. Goebel is amember of the American Society for Quality (ASQ) Certified QualityAuditor, certification no. 21361, Parenteral Drug Association, PDAComputer Products and Services Auditor certification No. 0003 and thePDA Industry Advisory Board for Technical Report #32.

2:30 Employ Innovative and Automated BusinessControl SolutionsIs there a way to create a flexible, adaptable technologyplatform for SOX compliance? What technology suitesare available to either scale up from existing applicationsor to integrate into an existing platform? Explore existingsolutions and evaluate if your current application can beaugmented with a flexible compliance platform.

• Reduce the reliance on manual approvals and sign-off

• Increase the automation of financial processes andtherefore the number of preventive controls

• Reduce the requirement for remotely sited financeteam members

• Significantly reduce the scope and cost of future SOX audits

• Case study of an early filer for SOX 404 certification — Learn how one company was able to map, document, control and provide a completeaudit trail of financial processes within acollaborative web-site

Steve Pugh, Chief Executive Officer, CODA Financials, Inc. Mr. Pugh is CEO of CODA Financials, Inc. in the Americas and he isresponsible for CODA’s US commercial operations covering the marketing,sales and support of CODA-Financials. He also sits on the CODA ExecutiveBoard and holds executive responsibility for the CODA Global Supportfunction. Steve qualified as a chartered accountant (FCA – ICAEW) whileworking in tax audit and accounting practices, before moving into financialcontroller positions in industry. He has been with CODA for over 18 yearsin various roles, having joined the company in 1986. His first position wasapplication consultant on the VMS product team, and he subsequentlybecame manager of consulting for the VAX products before heading upCODA’s professional services team. Steve moved into product managementbefore moving to the U.S. in 1996 to join a newly formed management teamas Vice President of professional services and support.

3:15 Close of Conference

Case Study

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ABOUT OUR CO-SPONSOR:

Deloitte refers to one or moreof Deloitte Touche Tohmatsu,a Swiss Verein, its memberfirms, and their respective

subsidiaries and affiliates. Deloitte Touche Tohmatsu is anorganization of member firms around the world devoted toexcellence in providing professional services and advice, focusedon client service through a global strategy executed locally innearly 150 countries. With access to the deep intellectual capitalof 120,000 people worldwide, Deloitte delivers services in fourprofessional areas — audit, tax, consulting and financial advisoryservices — and serves more than one-half of the world’s largestcompanies, as well as large national enterprises, publicinstitutions, locally important clients and successful, fast-growingglobal growth companies. Services are not provided by theDeloitte Touche Tohmatsu Verein, and, for regulatory and otherreasons, certain member firms do not provide services in all four professional areas.

As a Swiss Verein (association), neither Deloitte ToucheTohmatsu nor any of its member firms has any liability for each other’s acts or omissions. Each of the member firms is aseparate and independent legal entity operating under the names“Deloitte,” “Deloitte & Touche,” “Deloitte Touche Tohmatsu,” or other related names.

In the U.S., Deloitte & Touche USA LLP is the member firm of Deloitte Touche Tohmatsu, and services are provided by the subsidiaries of Deloitte & Touche USA LLP (Deloitte &Touche LLP, Deloitte Consulting LLP, Deloitte Tax LLP, andtheir subsidiaries) and not by Deloitte & Touche USA LLP. The subsidiaries of the U.S. member firm are among the nation’sleading professional services firms, providing audit, tax,consulting and financial advisory services through nearly 30,000 people in more than 80 cities. Known as employers of choice for innovative human resources programs, they arededicated to helping their clients and their people excel. For more information, please visit the U.S. member firm’swebsite at www.deloitte.com/us.

ABOUT OUR STRATEGIC CORPORATE SPONSOR:

PricewaterhouseCoopers’ Global Pharmaceutical IndustryGroup is dedicated to delivering effective solutions to thecomplex business challenges facing pharmaceutical andhealthcare products companies. As the global leader serving the industry, we have extensive experience in working withcompanies on industry-specific strategic, operational andfinancial issues. Our expertise includes assurance, tax andadvisory services, as well as specialized capabilities in regulatorycompliance, risk management and performance improvement. In helping our clients, we draw on the full knowledge and skillsof the firm’s professionals. More than 120,000 people in 143countries connect their thinking, experience and solutions to buildpublic trust and enhance value for clients and their stakeholders.For more information, please visit our website at:www.pwc.com/pharma

ABOUT OUR STRATEGIC PARTNER:

With a worldwide network of 70,000 professionals, Institute ofManagement Accountants is theworld’s leading organizationdedicated to empowering

managerial finance and accounting professionals to participatewithin their organizations to create economic value. Throughcertification, continuing education, thought leadership,networking and advocacy of the highest ethical and professionalpractices, IMA equips financial management and managementaccounting professionals to create value and build qualityfinancial practices into their organizations, helping to ultimatelyrebalance the accountancy profession. For more information aboutIMA, visit www.imanet.org.

ABOUT OUR SUPPORTING ORGANIZATIONS:

PharmaVOICE is the executive forumthat allows business leaders to engage ina candid dialogue on the myriad

challenges and trends impacting the life-sciences industry.PharmaVOICE reaches more than 17,000 U.S.-based executiveswho influence business strategies and affect change. Publishedmonthly, PharmaVOICE provides readers with insightful andthought-provoking commentary in a multiple-perspective formatthrough its forums, topics and articles that cover a range of issuesfrom molecule through market. To Raise Your VOICE, [email protected].

The Sarbanes-Oxley ResourceCenter, a key feature of AuditNet.org(www.auditnet.org) provides essential

tools to support your Sarbanes-Oxley projects. In addition tolinks to quality sites there is a Sarbanes-Oxley discussion forum,compliance manuals, audit programs, ICQ’s, checklists, books,policies and procedures. New material is added to the resourcecenter and subscriber area monthly. Visit AuditNet.org today and click on Sarbanes-Oxley Center!

Financial Executive is the award-winning flagship publication of FinancialExecutives International (FEI), the

premier association for senior financial executives such as CFOsand controllers. The magazine provides senior financialexecutives with financial, business and management news, trendsand strategies to help them work better, faster and smarter.

The Value Alliance and Corporate GovernanceAlliance provides solutions to CEOs, Boards andInvestors that improve governance and createsustainable value. We provide board evaluations,

board governance consulting, and in-depth financial andvaluation analyses to support the needs of both companies andinvestors. For more information, please visitwww.thevaluealliance.com.

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ACCLAIM FROM PREVIOUS ATTENDEES OF CBI’S PHARMACEUTICAL/BIOTECH

FINANCIAL SERIES EVENTS:

“This conference provides a real forum for pharmaceuticalfinancial executives to air their concerns about commonaccounting issues facing the pharmaceutical industry.”

— Gregory P. Hanson, Vice President and Chief Financial Officer,Avanir Pharmaceuticals

“Very few conferences address relevant accounting andindustry issues — This one did!”

— Deborah Griffin, Corporate Controller, TEVA

“The conference was excellent and very applicable to our business.”

— Carl Adams, Senior Manager of Accounting, Amgen, Inc.

“Having not yet fulfilled SOX requirements (foreign-based),hearing what others have done right and wrong was extremely helpful.”

— Marcia Rigsby, Controller, Intervet

“This was a useful conference, extremely relevant andpertinent to the pharmaceutical industry.”

— Jennifer Ritz, Senior Director of Finance,Nabi Biopharmaceuticals

“This conference was nicely organized and executed. Good agenda and presenters…Good Job!”

— Arturo Guillen, Associate Director of Finance, Wyeth

WHO SHOULD ATTEND:

From pharmaceutical/biotech/generic drug companies:CFOs, CCOs, CIOs, Board Members, Vice Presidents,Controllers, Directors, Managers and other senior executives with responsibilities in:

• Finance • Auditing• Corporate Governance • Reporting• IT • Contracts • Sarbanes-Oxley • Regulatory• Section 404 Accounting

Consultants, Software Providers and Auditing Firms would also benefit by attending this conference.

CBI Research, Inc’s corporate sponsors represent select companies thatshare a common mission: business advancement through thought

leadership, strategic interaction and innovation. The company’srepresented below are proud contributors on this program and havecarefully selected messaging, branding or positioning statements to

encourage the evaluation and investigation of quality products and/orservices available. We applaud these companies

as well as others that wish to join the conference as important members of this event’s delegation.

Current Sponsors and Exhibitors:

If you are interested in sponsorship or exhibit opportunities, please call KarenHanover at 781-939-2484, fax 781-939-2495 or email [email protected]

IN RECOGNITION OF OUR SPONSORS:

A Unit of CimQuest, Inc.

TM

Group ERM

Adherex Inc * Adolor * Akyma Pharmaceuticals * AlexionPharmaceuticals Inc * Allergan * Amgen Inc Antigenics * ApplixArena Pharmaceuticals * AstraZeneca * Avanir PharmaceuticalsAvera Pharmaceuticals Inc * Axentis Inc * Barr Laboratories BayerHealthcare * BioMarin Pharmaceutical Inc * Bone CareInternational Inc * BreakawayTechnologies * CedarburgPharmaceuticals LLC * Centocor Inc * Cephalon Inc * Chiron CorpCollaGenex * Pharmaceuticals Inc * Cornerstone BiopharmaCytogen Corp * Deloitte & Touche * Department of Justice * Dr.Reddys Laboratories Ltd * Elan Drug Delivery Inc * Eli Lilly & CoEndo Pharmaceutical Holdings Inc * Ernst & Young LLPEurand Inc * FEI * First Horizon Pharmaceutical Corp * ForestPharmaceuticals Inc * Genzyme Corp * GlaxoSmithKline * Hood& Strong LLP * I Many * IVAX Corp * InterMune Inc * IntervetKPMG LLP * Liberty Medical Supply * Merck & Co * MerzPharmaceuticals LLC * Mylan Pharmaceuticals * NABIPharmaceuticals * Neose Technologies * Novartis * NovenPharaceuticals Inc * OSI Pharmaceuticals * Office of InspectorGeneral * Otsuka America Pharmaceutical Inc * OvationPharmaceuticals Inc * Pfizer Inc * Pharmacy Business AssociationProtiviti * Public Company Accounting Oversight Board * PurduePharma LP * Ranbaxy Pharmaceutical Inc * SEC * STADAPharmaceuticals Inc * Schering-Plough Corp * Scios Inc * SepracorSerono * Serono International SA * Shemines Co * Sigma Tau Pharm Inc * Solvay Pharmaceuticals * Standard & Poors Sucampo Pharm Inc * Targacept Inc * Teamm Pharmaceuticals IncTeva Neuroscience Inc * Teva Pharmaceuticals * VelaPharmaceuticals v Wyeth Pharmaceuticals * ZLB Behring

Co-Sponsor:

Strategic Corporate Sponsor:

Executive Sponsors: Mini PortfoliosProvided by:

The Center for Business Intelligence isregistered with the National Association of State Boards of Accountancy as a sponsorof continuing professional education on theNational Registry of CPE Sponsors. State

boards of accountancy have final authority on the acceptanceof individual courses. Complaints regarding sponsors maybe addressed to NASBA, 150 Fourth Avenue North, Suite700, Nashville, TN 37219- 2417, phone: (615) 880-4200, Web site: www.nasba.org. Lecture Style: Group-Live,Seminar/Course Level: Advanced, Advance/Prerequisites:None, Recommended CPE Credit: up to 14.

The Center for Business Intelligence has been reviewed and approved as anAuthorized Provider by the InternationalAssociation for Continuing Education

and Training (IACET), 1620 I Street, NW, Suite 615,Washington, DC 20006.

JUST A FEW OF THE COMPANIES THAT HAVEBENEFITTED FROM CBI’S PHARMACEUTICAL/BIOTECH FINANCIAL CONFERENCE SERIES :

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Consultants and Vendors

29%

PharmaceuticalManufacturers

71%

SeniorAuditor/Accountant

6%

Director32%

Vice President10%

Manager20%

Controller16%

C-Level32%

MARK YOUR CALENDAR FOR UPCOMING EVENTS IN THIS SERIES :

PORTFOLIO EVALUATIONAND STRATEGIC INVESTMENT

DECISION-MAKING

C B I ’ S 4 T H P H A R M A / B I OT E C H S U M M I T O N

SEPTEMBER 26-27, 2005PARK HYATT HOTEL AT THE BELLEVUE * PHILADELPHIA, PA MARCH 20-21, 2006 • PHILADELPHIA, PA

PHARMACEUTICALACCOUNTING AND

REPORTING

CBI’S 2ND ANNUAL CONGRESS ON

PHARMACEUTICALACCOUNTING AND

REPORTING

WWW.CBINET.COM/PORTFOLIO

EXTENSIVE COVERAGE ON:

• Forecasting an accurate NPV and expected ROI for new products

• Methods for valuing enabling technologies and in-licensed drugs

• Quantifying and prioritizing a project’sorganizational importance and expected return

Industry-Specific Standards for SoundAccounting Practices, Efficient Internal

Controls and Compliant Financial Reporting

METRICS,VALUATION TOOLS AND PROJECTPRIORITIZATION TECHNIQUES FOR OPTIMIZING

YOUR COMPANY’S PORTFOLIO AND VALUE

PRACTICAL INSIGHTS AND GUIDANCE FOR:

• Revenue recognition — Rebates, chargebacks,off-label discounts and estimates

• Inventories — Trade and saleable inventory

• Government pricing — AMP, NFAMP, ASP and BP

WWW.CBINET.COM/ACCOUNTING

ABOUT CBI ’ S PHARMACEUTICAL/BIOTECH F INANCIAL SERIES :

AUDIENCE PROFILE:

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• Registration Fee: By 7/22/05 By 8/19/05 After 8/19/05 Conference & Workshop $1,495 $1,695 $1,995Conference only $1,195 $1,395 $1,695Workshop only $895 $895 $895Early Bird Discount — Register by July 22, 2005 and SAVE $500.Fee includes continental breakfast, lunch, cocktail reception, refreshmentsand conference CD-Rom compendium. Please make checks (in U.S. funds drawn on a U.S. bank) payable to CBI Research, Inc.(No personal checks accepted)

• Team Discount:Your organization may send 1 executive FREE for every 3 delegatesregistered. All registrations must be made at the same time to qualify.

• Discount Accommodations & Travel:Contact CBI’s official travel service Travel Concepts for all of your travel needs. Inorder to receive CBI’s special discounted hotel rate, you must call TravelConcepts at 800-640-8082 (508-879-8600 outside the U.S.) or [email protected] by September 9, 2005. Travel Concepts can also negotiate low group airfares and car rentals. Mention that you areattending CBI’s SUSTAINING SARBANES-OXLEY AND 404 COMPLIANCE toqualify for hotel and travel discounts.

• Venue:Hyatt Regency Princeton 102 Carnegie Center • Princeton, NJ 08540Negotiated rates only available through Travel Concepts

• Substitution & Cancellation:Your registration may be transferred to a member of your organization up to 24hours in advance of the conference. Cancellations received in writing on orbefore September 12, 2005 will be refunded, less a $195 administrative charge.No refunds will be made after this date; however, the registration fee less the$195 administrative charge can be credited to another CBI conference if youregister within 6 months from the date of this conference. In case of conferencecancellation, CBI’s liability is limited to refund of the conference registration feeonly. CBI reserves the right to alter this program without prior notice.

• Satisfaction Guaranteed:CBI stands behind the quality of its conferences. If you are not satisfied with thequality of the conference, a credit will be awarded towards a comparable CBIconference of your choice.

• Special Offer from The Wall Street Journal:As a special thank you for registering, you will receive 13 complimentary weeks ofThe Wall Street Journal — a $59 value! There is no further obligation. Pleasemake sure that the circle is checked on the registration page and we'll take careof the rest for you. Your first issue will arrive in 4 weeks. Offer good to newsubscribers only in the continental U.S.

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I am registering for the EARLY BIRD DISCOUNT. I cannot attend. Please send me a Conference CD-Rom Compendium.

As a special thank you for registering, I would like to receive 13 complimentary weeks of The Wall Street Journal FREE (a $59 value!)(Offer good for new subscribers only in the continental U.S. — your first issue will arrive approximately 4 weeks after registration.)

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CD-Rom CompendiumsIf you are unable to attend the conference or you would like extra copies for your colleagues,you can order your conference CD-Rom today.Don't miss out on the valuable information presented by industry leaders exclusively at thisevent. The CD-Rom is available for only $198.The CD-Rom includes overheads, articles andpresentations. Simply fill out the order form and the CD-Rom will be shipped to you 2 weeks after the conference occurs.

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Attend this Pharmaceutical-Specific Forum and Learn How toEase the Burden of Internal Control Assessment and Sustain

404 Compliance Efforts without Breaking the Budget.

Elite Faculty Include:

Hugh Donnelly,Vice President of Corporate Internal Audit, Pfizer Inc

Arthur S. Gabinet, District Administrator, Philadelphia Office,The U.S. Securities and Exchange Commission

Arnie Hanish, Chief Accounting Officer, Eli Lilly & Co

Anna M. Seal, Senior Vice President, Chief Financial Officer,GlaxoSmithKline Global Manufacturing and Supply

Steve Silverman, Director of the Division of New Drugs andLabeling Compliance, The Food and Drug Administration

REGISTER BY JULY 22, 2005 AND SAVE $500 OFF YOUR REGISTRATION FEE!

SEPTEMBER 26 -27 , 2005 • THE HYATT REGENCY • PRINCETON, NJ

CBI, IN ASSOCIATION WITH DELOITTE & TOUCHE USA LLP, PRESENTS:

Organized by: Co-Sponsored by:

Achieve Compliance, Derive Long-Term Value and Reduce Costsfrom SOX-Related Activities

THE PHARMACEUTICAL CONFERENCE ON SUSTAINING