2nd Annual Proactive GCP Compliance, April 2011, Arlington, VA

2nd annual

Proactive GCP CoMPlIAnCE

Building in Quality to Meet New Requirements and Ensure Patient Safety

April 4-6, 2011 • westin Arlington gateway • Arlington, vA

To Register: Call 866-207-6528 or visit us at www.exlpharma.com/gcp

your Annual Opportunity to Meet with Senior level Clinical Quality Experts to:• Remain in-step with current health authority expectations and priorities• Address FdA requirements through a quality systems approach• Compare varying methods to quality management• Improve your compliance system and master inspection readiness• Bring new QA/QC tactics and strategies back to your company• drive your business effectively in the current enforcement environment• Evolve from traditional QA to a quality management culture• Interpret and apply the regulatory nuances and ethics of emerging regions• Ensure the right mechanisms are in place for effective oversight • Share your experiences by actively participating in sessions as well as

end-of-day roundtable discussions

NEw FOR 2011!• Assessing site compliance and improving site quality• Risk-based approaches to compliance• Building a cooperative relationship between

QA and Clinical Operations• New approaches to monitoring activities• Minimizing protocol complexity• More time to interact with the FdA!

Featuring Sessions by:Ann Meeker-O’Connell, MS, Consumer Safety Officer, Office of Compliance, CdER, FdA

Conference Sponsor:

With Support from:

Benchmark your Clinical Compliance Strategy with the Following Companies on Our Faculty:ARRAY BIOPhARMAASTEllAS PhARMAASTRAZENECABIOGEN IDECBOEhRINGER-INGElhEIMElAN PhARMACEUTICAlSF. hOFFMANN-lA ROChE lTD.JOhNSON & JOhNSONMIllENNIUM: ThE TAkEDA ONCOlOGY COMPANYNOVARTIS PhARMACEUTICAlS CORPORATIONNOVARTIS VACCINES & DIAGNOSTICSPFIZERSEATTlE GENETICSShIRE PhARMACEUTICAlSThE MEDICINES COMPANY

PlUS! Hear from:ClINICAl PAThWAYS, llCCOMPlIANCE IMPlEMENTATION SERVICES, INC.FDAGlOBAl DRUG DEVElOPMENT ExPERTSGOOD ClINICAl PRACTICE AllIANCE – EUROPE (GCPA)hEAlTh CANADAMETRICS ChAMPION CONSORTIUMQD-QUAlITY AND TRAINING SOlUTIONS, INC.RxTRIAlSSTRATEGIC INITIATIVE FOR DEVElOPING CAPACITY IN EThICAl REVIEW (SIDCER)ThE WEINBERG GROUP

Proudly Presents:

Take advantage of in-depth half-day workshops on:• Achieving gCP Compliance

in Emerging Countries • Ensuring your Site Partners

are gCP Compliant

The only event designed to address gCP compliance challenges from

a strategic, senior level

Register by February 25, 2011 for the Best Savings

Who Should Attend:C-level, Vice President, Director & Manager level execu-tives from the following departments at Pharma/Biotech companies, CROs and other clinical trial service providers:

• Clinical Quality Assurance• Clinical Quality Control• Compliance/Global Compliance• Global Quality• Regulatory Affairs• Safety & Risk Management/Operations • Clinical Operations• Clinical Project Management• Clinical Monitoring

This conference is also relevant to clinical QA/ compliance professionals at:

• CROs• Central, Imaging and ECG Core labs• IRBs• IVRS vendors• Investigative Sites• Data management and computer software vendors• Safety Reporting vendors• ePROs

Hotel Information

westin Arlington gateway801 North glebe RoadArlington, virginia 22203Phone: (703) 717-6200

One of the newest hotels in the Washington D.C. area, The westin Arlington gateway enjoys prime access to its surrounding area. In the active Ballston area of Arlington, and just a short walk from the Ballston Metro Station, guests have the option of exploring Arlington, Virginia or venturing into the nation’s capital.If you require overnight accommo-dations, please contact the hotel to book your room. Exl Pharma has reserved a block of rooms at a discounted rate for conference partici-pants. Please mention Exl Pharma and the conference name to take advantage of this discount. You must book your room by Sunday, March 13, 2011 to be eligible for this rate. Please book your room early, as the rooms available at this rate are limited.


Dear Clinical Colleague:Now it its second year, Exl Pharma’s Proactive gCP Compliance conference aims to progress the shift toward building and maintaining an effective GCP quality management system to keep pace with US and global enforcement changes. As the industry turns its attention to risk management, vendor oversight, quality metrics, clinical CAPAs and global trials, this conference offers both executive strategy and practical guidance to help navigate change.

As the one and only annual gathering for senior level clinical quality and compliance professionals, our faculty brings you timely information on:

• The FDA’s risk-based approach to inspections• Oversight of clinical trial vendors• Process improvement and quality metrics• Achieving GCP compliance globally, including the emerging regions of China, India and latin

America• how to best work with investigator sites to ensure compliance• Changes in the monitoring model, including a Clinical Trial Transformation Initiative

(CTTI) update• Collaboration between QA and Clinical Operations• The latest on clinical CAPA implementation• New perspectives on:

■ Quality Management Systems■ Methods for inspection readiness■ International trial ethics■ Inspections in the Uk, China, India, Canada

• And more!

MORE PROgRAM CHOICE IN 2011With 18+ sessions led by over 30 expert speakers packed into our two main conference days, our 2nd annual conference offers a choice of concurrent sessions focused on Quality Management, Risk Management and Metrics, and Global Inspectional Approaches. (Consider bringing your colleagues to ensure you collect information from both tracks!)

don’t get Caught in Reactionary ModeEven a minor finding by regulatory authorities requires greater resource allocation and a shift in priorities that can impede daily operations. The quality bar has been raised, and our industry must follow. We look forward to helping you meet your GCP requirements through a proactive approach beginning on April 4th in Arlington, VA.

Sincerely yours,

Pam Sobotka, Program Director, Exl Pharma

p.s. Take advantage of our team discounts! See page 7 for details.

7:30 Registration and Morning Coffee

8:00 CHAIRPERSONS’ wElCOMEWilliam Woodward, former VP, Global compliance and training, WYetH PHARMAceuticAlSMonjit Summy, MRPharmS, DMS, Head of Global R&D QA, SHiRe PHARMAceuticAlS

8:15 FdA KEyNOTE AddRESSUpdate on Current Enforcement Initiatives and guidance on Current gCP ChallengesThe current FDA administration under the leadership of Margaret Hamburg has vowed to create a strong agency that supports compli-ance via effective enforcement. However, as clinical trials continue to grow in complexity and size and are often conducted across the globe in emerging countries, what level of compliance is acceptable versus unacceptable? Is 100% GCP compliance an expected standard or an unattainable ideal? Our presenter provides an update on: • DSI’s risk-based approach to inspections• Providing an acceptable response to an FDA 483 or Warning Letter:

What has and has not been deemed acceptable • Protocol deviations/violations: What is serious and what may be

acceptable• FDA’s current efforts in assessing oversight of CROs by sponsors• The FDA/EMA Pilot ProgramAnn Meeker-o’connell, MS, consumer Safety officer, office of compliance, cDeR, FDA

9:15 PANEl dISCUSSIONIndustry Response to Regulatory Agency Changes: driving the Business in the New Enforcement EnvironmentOur panel addresses:• Changes in industry compliance practices resulting from changes at FDA

and EU health authorities • Is your current risk-based model appropriate? What approach should

you use? • Utilizing Quality by Design as a risk management approach • The types of approaches sponsors and providers taking with over-

sight: Are there collaborative approaches that have worked? • Response to the FDA’s Final Rule governing safety analysis and reporting • New challenges in the differing environments of clinical and pharma-

covigilance• Where should industry focus its resources? MODeRatOR: Annette Horner, Senior Director, clinical compliance, coMPliANce iMPleMeNtAtioN SeRViceS (ciS)Panelists:terrance J. Stevens, Director, cQA, ARRAY BioPHARMAJoanne Spallone, Global Head, Audit, clinical Quality Assurance, uSeH, NoVARtiS PHARMAceuticAlS coRPoRAtioNJanice B. Wilson, PhD, Vice President corporate Quality Assurance, BioNeurology, elAN PHARMAceuticAlS, iNc. Mark Behm, Director compliance Advice & Assurance, clinical Quality and capability Development, AStRAZeNecA

10:15 Networking and Refreshment Break

Morning Workshop • 8:30 – 12:008:00 Registration and Morning Coffee for workshop

8:30 A: ACHIEvINg gCP COMPlIANCE IN EMERgINg COUNTRIESPharmaceutical companies and CROs are rapidly expanding to emerging countries in order to more rapidly and cost-effectively recruit for clinical trials that continue to grow in size and complexity. It is necessary to evaluate cultural attributes, healthcare infrastructure and identify the key challenges of conducting a high quality trial that will withstand inspections from global regulatory authorities. Whether you use a local CRO, site, IRB or other vendor in one of the emerging countries or a Global player with presence in that region, there is an added level of oversight and manage-ment to ensure compliance and avoid lapses in meeting international qual-ity standards. You might qualify a vendor at a US location, only to find out that their affiliate offices outside of the US might not measure up. Do you assume the company’s staff in emerging regions understand and adhere to their global SOPs? Are the levels of documentation accurate? How do you assess differences in qualifications and experience? Our speakers cover:• Conducting careful due diligence, planning, and proactive management • Approaches to optimize opportunity while minimizing risks• FDA, ICH and International standards vs country specific regulations,

guidances and practices• Comparison of quality issues between the US and emerging countries• Complexities of vendor selection when working across the globe and

with different cultures• Key factors to consider when overseeing teams at global or local

CROs in emerging countries• What can be done to prevent compliance related issues during the

conduct of a study • General inspection readiness for sponsors and sites, covering India,

China, Argentina and Tanzania

DistinguisheD WORkshOP leaDeRs:Munish Mehra, PhD, Managing Director, GloBAl DRuG DeVeloPMeNt eXPeRtSDr. Helen Q. li, emerging Market QA-Asia lead, PFiZeR MeDicAl QuAlitY ASSuRANce Val Mikhailovski, Head Global clinical Quality & compliance, Global clinical Research & Development, NoVARtiS VAcciNeS & DiAGNoSticS

10:00 30-Minute Break

12:00 workshop Concludes; luncheon for Morning workshop delegates

Afternoon Workshop • 1:30 – 5:001:00 Registration for Afternoon workshop

1:30 B: ENSURINg yOUR SITE PARTNERS ARE gCP COMPlIANT The FDA has said that even small deviations in quality can prevent your product from being approved. In this enhanced enforcement environment, sponsors must take steps to ensure a strong partner-ship with their sites. This workshop aims to teach you how to take the “heartbeat” of the GCP compliance practices of your investigator site partners and where their gaps may ultimately leave you surprisingly exposed. Our workshop leaders cover how to:• Determine the amount of education and training needed at the site level• Use the monitoring visit in the most productive way• Understand the new FDA audit practice and assess whether your

sites are “audit ready”• Ensure your sites and monitors realize the differences between Notes

to File and CAPA • Determine areas where sites are most vulnerable to compliance

breaches• Conduct a site risk assessment: Things to consider regardless of

who’s looking• Discover red flags that your site is entering dangerous waters and

get them back on course• Tell when a site is truly non-compliant versus sloppy and how to

approach each issue appropriately• Deal with investigator non-compliance

DistinguisheD WORkshOP leaDeRs:christine Pierre, President, RX tRiAlSliz Wool, ccRA, cMt, President & ceo, QD-QuAlitY AND tRAiNiNG SolutioNS, iNc.; Member, Board of trustees, Association of clinical Research Professionals (AcRP)Sandra SAM Sather, MS, BSN, ccRA, ccRc, cliNicAl PAtHWAYS, llcSharon luzie, Head, Quality Monitoring & compliance, JoHNSoN & JoHNSoN

3:00 30-Minute Break

5:00 workshop Concludes

MAIn ConFEREnCE DAY onE • Tuesday, April 5, 2011

HAlF-DAY WoRkSHoPS • Monday, April 4, 2011

BREAKOUT SESSIONS: CHOOSE A OR BA: Quality Management

10:45 CONTINUOUS IMPROvEMENT OF gCP QUAlITy – ESTABlISHINg A lEARNINg ORgANIzATION

This session focuses on:• How to develop robust process standards, monitor processes and

establish significant key performance indicators• Deploy risk analysis to proactively identify potential compliance is-

sues and establish quality indicators• Implement quality in clinical trials by design• Define a transparent CAPA system with input from all sources and

clearly defined accountability• Apply systematic and timely root cause analysis • Utilize automated and centralized documentation to support knowl-

edge sharing• Establish the culture of a learning organization where employees

are motivated to increase quality and productivity as well as reduce compliance risks

Arthur Hecht, Global Functional lead compliance, Head of QM - Medicine & Regulatory Western europe South, BoeHRiNGeR iNGelHeiM PHARMA GMBH & co. KGDaniel J. Greenwood, Sr. Associate Director, Quality Management-Medicine & Regulatory (QM-M&R), BoeHRiNGeR iNGelHeiM PHARMAceuticAlS, iNc.

11:30 BENEFITS OF BUIldINg AN INTEgRATEd RElATIONSHIP BETwEEN QA ANd ClINICAl

This session presents an approach to development of a highly integrated model of collaboration between Clinical Quality Assurance and Clinical Development that supports implementation of a Quality Systems Management approach to the clinical development process. After this session attendees should be able to: • Describe an integrated model for collaboration between Clinical

Quality Assurance and Clinical Development • List several key components necessary to implement clinical Quality

Systems Management in the clinical development environment • Discuss the roles of Clinical Operations and Clinical Quality in the

Quality Systems Management model • Describe potential benefits to the QA-Clinical relationship and

overall program quality through the implementation of clinical Quality Systems Management

Donna edgerton, Senior Director, clinical Quality Standards QA, MilleNNiuM: tHe tAKeDA oNcoloGY coMPANYKaren Brennan, VP, clinical operations, MilleNNiuM: tHe tAKeDA oNcoloGY coMPANY

B: Risk Management and Metrics

10:45 QUAlITy RISK MANAgEMENT IN gCP ANd PHARMACOvIgIlANCE: THE NEw PARAdIgM

Our speaker discusses the general principle of Quality Risk Manage-ment (QRM) in GCP and PV, how it works and what regulators are currently saying about it. He also covers strategic risk management in GCP and PV with governance model and processes, including obtain-ing senior management support. Finally, tools are highlighted which can be used in QRM, such as automated tools that pull data from systems, calculate risk according to set algorithms or questionnaires, and probe in a standardized way into the processes to reveal the risks lying below. Dr. Peter Schiemann, Global Head, Quality Risk Management, clinical Quality Assurance, F. HoFFMANN-lA RocHe ltD.

11:30 UTIlIzINg STANdARdIzEd ClINICAl TRIAl PERFORMANCE METRICS TO dRIvE QUAlITy MANAgEMENT IN ClINICAl TRIAlS

In this session, presenters discuss a collaborative effort to develop and utilize standardized clinical trial performance metrics, including quality metrics, to drive process improvement and quality management of clinical trials. Our speakers discuss: • Standardized performance metrics aimed to improve efficiency and

delivery of clinical trial operations• Study start-up and study conduct quality scoring tools that evaluate

protocol writing, site selection and site performance with an aim to balance the quest for short-term speed against the need to run an efficient, high quality trial

• Opportunities to participate in a MCC member metrics benchmarking database

Guy Mascaro, President, MetRicS cHAMPioN coNSoRtiuM (Mcc)Jeanne Green, chair, Mcc Process improvement / Quality, Management Working Group, MetRicS cHAMPioN coNSoRtiuM (Mcc)

12:15 luncheon

1:30 FEATUREd AddRESSHow Sponsors and Providers Can Operationally Address FdA Requirements and Initiatives through a Quality Systems ApproachOur FDA speaker returns to follow up her keynote address with practi-cal industry advice including: • The range of acceptable monitoring practices for clinical trials,

including monitoring as part of sponsor’s larger, risk-based quality oversight

• CTTI update: Leveraging existing data and new technology (EDC) to inform monitoring strategies, central approaches to clinical trial oversight, and monitoring and quality plans

• How clinical trial oversight and R&D compliance may fit within a larger enterprise-wide compliance program

• Systems or processes the FDA observes during audits that may be best practices

• Clinical trials disclosure under FDAAA, Title VIIIAnn Meeker-o’connell, MS, consumer Safety officer, office of compliance, cDeR, FDA

2:30 INCORPORATINg gCP INSPECTION REAdINESS FROM dAy ONE OF yOUR PROjECT

There are elements of your quality plan which must be built into the project at the outset (e.g., monitoring plan), rather than being the last thing to organize at the end of a trial. Although there is no formal requirement to have certain processes in place, you must be able to articulate your quality system and your risk management strategy throughout a trial. Our speaker covers:• How to define and mitigate your risks early on in the trial• How to organize your documents before an inspection• The type of escalation process you should have• How to effectively interact with the FDA: Dos and Don’ts• How to substantiate process improvements with documentation: Can

you tell the complete story to the regulators?• How to help prepare your sites for a successful interaction with a

regulatory agency• How to provide effective CAPA without overcommitting corrective

action and timelines J. Michael Sobczyk, Director, Global clinical Quality, BioGeN iDec


BREAKOUT SESSIONS: CHOOSE A OR BA: Quality Management

4:00 CAPAS FOR gCP: A SUMMARy OF Exl’S jANUARy 2011 ClINICAl CAPA CONFERENCE

Our speaker presents a recap of the lecture, case study, round-table discussion and interactive exercise presented at our January 18-19, 2011 conference, meant to move our grasp of corrective and preventive actions in the GCP environment an important step forward, ultimately to support your company’s overall clinical quality efforts. The GCP arena has come to a crossroads wherein processes must be put in place to correct current problems and demonstrate that the problem has indeed been fixed. In addition, processes must be designed to prevent the problem from recurring. He reviews:• CAPA action items for clinical development• Current challenges of CAPA implementation• Summary of regulatory expectations• Industry examplesWilliam Woodward, former VP, Global compliance and training, WYetH PHARMAceuticAlS


4:00 SITE SURvEy RESUlTS! IMPACT OF INvESTIgATOR SITE METRICS ON SPONSORS

With the change afoot in the monitoring model, who is ensuring your sites are GCP compliant? Our speaker delivers results from a 2010 survey of over 100 sites where 80% have been in the site business for 5 plus years. Information was collected on staffing, payments terms to investigators, ROI for coordinators and site’s current practices regard-ing compliance and quality assurance at their sites. These metrics will provide useful information sponsors need to know in order to effectively assess sites’ compliance programs and best practices that should be employed to build successful relationships with their sites.christine Pierre, President, RxtRiAlS

7:45 Morning Coffee

8:15 CHAIRPERSONS’ OPENINg REMARKS ANd RECAP OF dAy ONEWilliam Woodward, former VP, Global compliance and training, WYetH PHARMAceuticAlSMonjit Summy, MRPharmS, DMS, Head of Global R&D QA, SHiRe PHARMAceuticAlS

8:30 ACHIEvINg A COMMON gCP STANdARd IN INTERNATIONAl ClINICAl TRIAlS: ETHICS, QUAlITy, ANd COMPlIANCE

• US and European expectations for GCP in international clinical trials • The ICH and WHO attempts to standardize GCP across countries and

regions • GCP in emerging countries: national interests trumping international

standards • The relationship between ethical considerations, codes of ethics, ethical

review practices and GCP in and outside the US and European Union • The impact of clinical trial registration and results publications in

global clinical trials: clinicaltrials.gov, EUDRACT, and WHO influences • GCP quality and compliance in international clinical trials • The role of GCP and ethical considerations in the registration of medicines Francis P. crawley, GooD cliNicAl PRActice AlliANce – euRoPe (GcPA) & StRAteGic iNitiAtiVe FoR DeVeloPiNG cAPAcitY iN etHicAl ReVieW (SiDceR)

9:30 EMA UPdATE: OvERvIEw OF EMA INSPECTIONS ANd COllABORATIvE EFFORTS wITH THE US FdA

The FDA and EMA are currently working on building a mutual under-standing of their GCP inspection processes utilized in the EU/EEA and US through the sharing of information and cooperation in the conduct of inspections. The point is not necessarily to agree on the findings observed. Rather, the two groups are working towards detecting the same findings in their inspections in order to come to the same conclu-sion. Our presenter addresses:• Explanation of EMA’s process-based inspections• Inspection procedures, combining investigator sites and sponsor site

inspections• Definitions of what are “critical” or “major” or “minor” observationseuropean Regulatory Authority invited


5:00 INTERACTIvE ROUNd TABlE dISCUSSIONSChoose your preferred topic and discuss in an intimate setting. At-tendance per table is limited. You will be asked for your selection when you register.1. Optimizing Training of QA Staff at Sponsors and Service Providers 2. Gaining Support of Senior Management to Obtain Additional Staff

and Resources 3. Ensuring Quality in the Virtual Environment4. Clinical Vendor Oversight5. The Link between Clinical Data Integrity and Product Promotion:

Confirming Claims Are Substantiated with Robust Clinical Data6. Open TableIf you would like to suggest a roundtable discussion topic please email Program Director, Pam Sobotka at [email protected].

6:00 day One Concludes

MAIn ConFEREnCE DAY TWo • Wednesday, April 6, 2011


“ Thank you very much for this excellent conference. The lively discussions around the presentations were really beneficial.”– Dr. Sabine Schäfer-Preuß, Senior International

Training Manager, lOC Coordination and Training, NYCOMED GMBh

BREAKOUT SESSIONS: CHOOSE A OR BA: Global Inspectional Approaches

10:45 A PRACTICAl APPROACH TO MANAgINg INSPECTIONS By THE MHRAOur speaker, who manages MHRA inspections at Shire Pharmaceuticals in the United Kingdom, provides first-hand information on:• Experiences with MHRA inspections in the UK and lessons learned

from both GCP and PV perspectives• How is the MHRA checking for adequate oversight of trials?• Update on the regulation on Breach of GCP and subsequent reporting

requirements • Examples of what is most commonly focused on and commented on

during inspections• Planning and preparation for inspectionsMonjit Summy, MRPharmS, DMS, Head of Global R&D QA, SHiRe PHARMAceuticAlS

11:30 BUIldINg THE gCP FOUNdATION FOR ClINICAl TRIAlS IN ASIAFollowing the 2007 overhaul of the State Food and Drug Association of China (SFDA), new provisions were put in place to strengthen over-sight of drug safety. Our presenter worked closely with PhRMA, US FDA Regulators and Asian regulatory officials in 2009 to help build the foundation of the GCP environment in Asia. This presentation updates us on this effort and specifically offers information and insight into:• Setting standards for the acceptance of global data• Specific GCP efforts with Asian regulatory authorities• Efforts ensuring successDr. Helen Q. li, emerging Market QA-Asia lead, PFiZeR MeDicAl QuAlitY ASSuRANce


10:45 PROTOCOl COMPlExITy AS A FACTOR IN RISK MANAgEMENTThis session reviews how protocol complexity adds to operational and compliance risk in clinical trials. Strategies to minimize complexity are discussed and the need for proactive risk management explored. Elements of complexity our speaker covers include:• Size of the clinical trial • Multiple primary/secondary endpoints • Protocol requirements that deviate from institutional standard(s) of care• Confirmation of eligibility by central review• Progression free survival as a primary endpoint • Dose adjustment/titration requirementsMarta Fields, Director, clinical Quality Assurance, SeAttle GeNeticS

11:30 KEy PERFORMANCE INdICATORS (KPIs), KEy QUAlITy INdICATORS (KQIs) vERSUS KEy RISK INdICATORS (KRIs): HOw TO dIFFERENTIATE ANd UTIlIzE FOR TRENdINg ANd ANAlySIS

Whether called KQIs or leading/lagging indicators, there is a consen-sus that metrics should be collected and utilized to change an existing behavior for the better. Setting up a metrics program and then using the metrics effectively can mean the difference in future successes in our changing regulatory environment. Our panel discusses:• Trending audit findings, resulting in a risk management approach• How to monitor critical and major observations• The difference between KPIs, KQIs and KRIs with examplesPanelists:Maryann livolsi, BSN, MSN, RN, RQAP-GcP, Associate Director, Global R&D Quality Assurance, SHiRe PHARMAceuticAlS Ginny Fanning, Associate Program Director, compliance Management, GR&D QA, JoHNSoN & JoHNSoN

12:15 luncheon

1:30 HEAlTH CANAdA’S gCP COMPlIANCE PROgRAM• History of the program• Inspection planning• Site selection• Inspection process• Updated trends and commonly found observationsAlicja Kasina Phc, MSc, Drug Specialist, GcP compliance unit, HPFB inspectorate, HeAltH cANADA

2:15 PANEl dISCUSSIONOptimizing the Expanding Role of Monitoring with varied Approaches: A debate Recent warning letters and compliance trends suggest that monitoring activities and monitoring reports are failing to detect and identify criti-cal issues that impact the protection of human subjects and the quality and integrity of clinical trial data. This trend suggests there needs to be a new approach to monitoring activities. However, one size does not fit all. Our panel presents different approaches and tools for monitoring and debate their effectiveness and efficiency depending on the size and type of company utilizing them. MODeRatOR:carol Bognar, Senior Director, GcP Services, tHe WeiNBeRG GRouP

Panelists:Sabrina comic-Savic, Senior Director GcP, R&D, tHe MeDiciNeS coMPANYMaggie Ayers, BSc, Director, clinical Study Management, Global clinical Science, AStellAS PHARMA GloBAl DeVeloPMeNt, iNc.Sharon luzie, Head, Quality Monitoring & compliance, JoHNSoN & JoHNSoN

3:00 Conference Concludes

Do You Want to Reach the Audience at This Event?If you are interested in:

• Reaching a senior-level audience (Director level and above) of Clinical QA and Compliance professionals at pharma and biotech companies (those professionals who impact their companies’ decision to partner with you via their qualification audits)

• Reaching sponsor-side Clinical Operations professionals (Manager level and above, who work hand-in-hand with QA to oversee the quality of your work and help make the outsourcing decision)

• Showcasing your company’s stellar audit/inspection record to influence future partner-ing decisions

• Draw attention to your company’s tools, processes, or software, that offer sponsors confidence in the quality of your work

. . . you should consider being part of this important conference.

Maximize your marketing dollars by exhibiting, or increase your exposure even further by sponsoring a cocktail reception, luncheon or breakfast. To learn more about these marketing opportunities, please call Business development Manager, lucas Carrasco at 212-400-6231; E-mail at [email protected]

Conference Partner:

Compliance Implementation Services (CIS) is a consulting firm specializing in compliance strategies for pharmaceutical

companies, from Global Clinical Research & Development through Manufacturing, U.S. Commercial Compliance and Government Programs. Founded in 2004, CIS provides its clients with a deep understanding of industry laws and regulations, innovative and practical applications and custom solutions to establish a “Culture of Compliance” that is both meaningful and sustainable.

Our experts identify, assess and prioritize your organiza-tion’s exposure to compliance risks, subsequently devel-oping and implementing risk evaluation and mitigation techniques to ensure adherence to legal and regula-tory requirements.

Conference Support from:ACRP is the primary resource for clinical research professionals in the phar-maceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. ACRP was founded in

1976 to address the distinct educational and networking needs of research nurses and others who supported the work of clinical investigations. With its own professional society came the recognition of a new distinctive profession – that of the clinical researcher. More than 30 years later, ACRP is a global association comprised of more than 18,000 individuals in over 60 countries dedicated to clinical research and development.

The Metrics Champion Consortium (MCC) is an open, multidisci-plinary, non-profit organization comprised of biotechnology, pharmaceuti-cal and service provider organizations. The mission of MCC is to develop,

through a collaborative process, Performance Metrics within the Biotechnology and Pharmaceutical industry with the intent to jointly encourage performance improvement, effectiveness, efficiency, and appropriate levels of controls for both Sponsors and Service Providers in support of the drug development process.

Additional Support from:

Five Ways to RegisterFAx: 888-221-6750MAIl: Exl Events, Inc. 555 8th Ave, Ste 310 New York, NY 10018PhONE: 866-207-6528ONlINE: www.exlpharma.com/GCPEMAIl: [email protected]

Registration Fees for Attending Exl’s 2nd annual Proactive gCP Compliance:EARlY BIRD PRICING Register by February 25th, 2011:Conference + Both Workshops $2195Conference + One Workshop $1995Conference Only $1695

STANDARD PRICINGRegister after February 25th, 2011: Conference + Both Workshops $2395Conference + One Workshop $2195Conference Only $1895

ONSITE PRICINGConference + Both Workshops $2495Conference + One Workshop $2295Conference Only $1995

Inquire about our Full-Time Academic and Government Rates – call 866-207-6528

group discount Program: Discounts cannot be combined; Early Bird Rates do not apply; All discounts are taken from the standard rate.Save 25% per person when Registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). This is a savings of 25% per person. Save 15% per person when Registering Three Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call 866-207-6528. Make checks payable to ExL Events, Inc. and write code P1309 on your check. You may also use Visa, MasterCard, Discover or American Express. All payments are due 2 weeks prior to the event. Registrations after March 21st require immediate payment.Cancellations: If you need to cancel your registration for an upcoming ExL conference, please note the following policies derived from the Start Date of the event:Four weeks or more: A full refund (minus a $95 processing fee), or a voucher to another ExL event valid for two years from the voucher issue date.Four weeks or Less: A voucher to another ExL event valid for two years from the voucher issue date.To receive a refund or voucher, please fax your request to 888-221-6750.Please Note: Conference registrations may be transferred to other colleagues in the event you are unable to attend. There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of any ExL conference.Please notify ExL Pharma, [email protected], prior to the event with the name and contact information of the replacement attendee.Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacement will be made.*The opinions of this faculty do not necessarily reflect those of the companies they represent nor ExL Events, Inc.*

Registration FormMail: Exl Events, Inc. Phone: 866-207-6528 555 8th Ave, Ste 310 Fax: 888-221-6750 New york, Ny 10018 Email: [email protected]: www.exlpharma.com/gCP

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2nd annual

Proactive GCP CoMPlIAnCE

Building in Quality to Meet New Requirements and Ensure Patient Safety

April 4-6, 2011 • westin Arlington gateway • Arlington, vA


NEw FOR 2011!• Assessing site compliance and improving

site quality• Risk-based approaches to compliance• Building a cooperative relationship between

QA and Clinical Operations• New approaches to monitoring activities• Minimizing protocol complexity• More time to interact with the FdA!

Take advantage of in-depth half-day workshops on:• Achieving gCP Compliance

in Emerging Countries

• Ensuring your Site Partners are gCP Compliant

ARRAY BIOPhARMAASTEllAS PhARMAASTRAZENECABIOGEN IDECBOEhRINGER-INGElhEIMElAN PhARMACEUTICAlSF. hOFFMANN-lA ROChE lTD.JOhNSON & JOhNSONMIllENNIUM: ThE TAkEDA ONCOlOGY COMPANY

NOVARTIS PhARMACEUTICAlS CORPORATIONNOVARTIS VACCINES & DIAGNOSTICSPFIZERSEATTlE GENETICSShIRE PhARMACEUTICAlSThE MEDICINES COMPANY

ClINICAl PAThWAYS, llCCOMPlIANCE IMPlEMENTATION SERVICES, INC.FDAGlOBAl DRUG DEVElOPMENT ExPERTSGOOD ClINICAl PRACTICE AllIANCE – EUROPE (GCPA)hEAlTh CANADA

METRICS ChAMPION CONSORTIUMQD-QUAlITY AND TRAINING SOlUTIONS, INC.RxTRIAlSSTRATEGIC INITIATIVE FOR DEVElOPING CAPACITY IN EThICAl REVIEW (SIDCER)ThE WEINBERG GROUP

Benchmark your Clinical Compliance Strategy with the Following Companies on Our Faculty:

PlUS! Hear from:

Conference Sponsor:

With Support from:

Proudly Presents:

2nd Annual Proactive GCP Compliance, April 2011, Arlington, VA

Documents

Transcript of 2nd Annual Proactive GCP Compliance, April 2011, Arlington, VA