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


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Building in Quality to Meet New Requirements and Ensure Patient Safety

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

  1. 1. Register by The only event designed to addressFebruary 25, 2011 gCP compliance challenges fromfor the Best Savings 2nd annual a strategic, senior level Proactive GCP CoMPlIAnCE Proudly Presents:Benchmark your ClinicalCompliance Strategy withthe Following Companieson Our Faculty: Building in Quality to Meet New RequirementsARRAY BIOPhARMAASTEllAS PhARMA and Ensure Patient SafetyASTRAZENECABIOGEN IDEC April 4-6, 2011 • westin Arlington gateway • Arlington, vABOEhRINGER-INGElhEIMElAN PhARMACEUTICAlSF. hOFFMANN-lA ROChE lTD. your Annual Opportunity to Meet with Senior levelJOhNSON & JOhNSON Clinical Quality Experts to:MIllENNIUM: ThE TAkEDAONCOlOGY COMPANY • Remain in-step with current health authority expectations and prioritiesNOVARTIS PhARMACEUTICAlS CORPORATIONNOVARTIS VACCINES & DIAGNOSTICS • Address FdA requirements through a quality systems approachPFIZER • Compare varying methods to quality managementSEATTlE GENETICS • Improve your compliance system and master inspection readinessShIRE PhARMACEUTICAlSThE MEDICINES COMPANY • Bring new QA/QC tactics and strategies back to your company • drive your business effectively in the current enforcement environmentPlUS! Hear from: • Evolve from traditional QA to a quality management cultureClINICAl PAThWAYS, llCCOMPlIANCE IMPlEMENTATION SERVICES, INC. • Interpret and apply the regulatory nuances and ethics of emerging regionsFDA • Ensure the right mechanisms are in place for effective oversightGlOBAl DRUG DEVElOPMENT ExPERTS • Share your experiences by actively participating in sessions as well asGOOD ClINICAl PRACTICE AllIANCE – end-of-day roundtable discussionsEUROPE (GCPA)hEAlTh CANADAMETRICS ChAMPION CONSORTIUMQD-QUAlITY AND TRAINING SOlUTIONS, INC. NEw FOR 2011! FeaturingRxTRIAlS • Assessing site compliance and improving site quality Sessions by:STRATEGIC INITIATIVE FOR DEVElOPINGCAPACITY IN EThICAl REVIEW (SIDCER) • Risk-based approaches to compliance Ann Meeker-O’Connell,ThE WEINBERG GROUP • Building a cooperative relationship between MS, Consumer Safety QA and Clinical Operations Officer, Office ofTake advantage of • New approaches to monitoring activities Compliance, • Minimizing protocol complexity CdER, FdAin-depth half-day • More time to interact with the FdA!workshops on:• Achieving gCP Compliance Conference With Support in Emerging Countries Sponsor: from:• Ensuring your Site Partners are gCP Compliant To Register: Call 866-207-6528 or visit us at
  2. 2. Who Should Attend: C-level, Vice President, Director & Manager level execu-Dear Clinical Colleague: tives from the following departments at Pharma/Biotech companies, CROs and other clinical trial service providers: • Clinical Quality Assurance • Clinical Quality ControlNow it its second year, Exl Pharma’s Proactive gCP Compliance conference aims to • Compliance/Global Complianceprogress the shift toward building and maintaining an effective GCP quality management • Global Qualitysystem to keep pace with US and global enforcement changes. As the industry turns its • Regulatory Affairsattention to risk management, vendor oversight, quality metrics, clinical CAPAs and global • Safety & Risk Management/Operationstrials, this conference offers both executive strategy and practical guidance to help navigate • Clinical Operationschange. • Clinical Project Management • Clinical MonitoringAs the one and only annual gathering for senior level clinical quality and compliance professionals, This conference is also relevant to clinical QA/our faculty brings you timely information on: compliance professionals at: • The FDA’s risk-based approach to inspections • CROs • Oversight of clinical trial vendors • Central, Imaging and ECG Core labs • Process improvement and quality metrics • IRBs • Achieving GCP compliance globally, including the emerging regions of China, India and latin • IVRS vendors America • Investigative Sites • how to best work with investigator sites to ensure compliance • Data management and computer software vendors • Changes in the monitoring model, including a Clinical Trial Transformation Initiative • Safety Reporting vendors (CTTI) update • ePROs • Collaboration between QA and Clinical Operations • The latest on clinical CAPA implementation • New perspectives on: ■ Quality Management Systems Hotel Information ■ 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, our2nd annual conference offers a choice of concurrent sessions focused on Quality Management,Risk Management and Metrics, and Global Inspectional Approaches. (Consider bringing your westin Arlington gatewaycolleagues to ensure you collect information from both tracks!) 801 North glebe Road Arlington, virginia 22203don’t get Caught in Reactionary Mode Phone: (703) 717-6200Even a minor finding by regulatory authorities requires greater resource allocation and ashift in priorities that can impede daily operations. The quality bar has been raised, and One of the newest hotels in the Washington D.C. area, The westinour industry must follow. We look forward to helping you meet your GCP requirements Arlington gateway enjoys prime access to its surrounding area. In thethrough a proactive approach beginning on April 4th in Arlington, VA. active Ballston area of Arlington, and just a short walk from the Ballston Metro Station, guests have the option of exploring Arlington, Virginia orSincerely yours, 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 takePam Sobotka, Program Director, Exl Pharma advantage of this discount. You must book your room by Sunday, March 13, 2011 to be eligible for this rate. Please book your roomp.s. Take advantage of our team discounts! See page 7 for details. early, as the rooms available at this rate are limited. To Register: Call 866-207-6528 or visit us at
  3. 3. HAlF-DAY WoRkSHoPS • Monday, April 4, 2011Morning Workshop • 8:30 – 12:00 Afternoon Workshop • 1:30 – 5:008:00 Registration and Morning Coffee for workshop 1:00 Registration for Afternoon workshop8:30 A: ACHIEvINg gCP COMPlIANCE IN EMERgINg COUNTRIES 1:30 B: ENSURINg yOUR SITE PARTNERS ARE gCP COMPlIANT Pharmaceutical companies and CROs are rapidly expanding to emerging The FDA has said that even small deviations in quality can prevent countries in order to more rapidly and cost-effectively recruit for clinical your product from being approved. In this enhanced enforcement trials that continue to grow in size and complexity. It is necessary to environment, sponsors must take steps to ensure a strong partner- evaluate cultural attributes, healthcare infrastructure and identify the key ship with their sites. This workshop aims to teach you how to take the challenges of conducting a high quality trial that will withstand inspections “heartbeat” of the GCP compliance practices of your investigator site from global regulatory authorities. Whether you use a local CRO, site, IRB partners and where their gaps may ultimately leave you surprisingly or other vendor in one of the emerging countries or a Global player with exposed. Our workshop leaders cover how to: presence in that region, there is an added level of oversight and manage- • Determine the amount of education and training needed at the site level ment to ensure compliance and avoid lapses in meeting international qual- • Use the monitoring visit in the most productive way ity standards. You might qualify a vendor at a US location, only to find out • Understand the new FDA audit practice and assess whether your that their affiliate offices outside of the US might not measure up. Do you sites are “audit ready” assume the company’s staff in emerging regions understand and adhere to • Ensure your sites and monitors realize the differences between Notes their global SOPs? Are the levels of documentation accurate? How do you to File and CAPA assess differences in qualifications and experience? Our speakers cover: • Determine areas where sites are most vulnerable to compliance • Conducting careful due diligence, planning, and proactive management breaches • Approaches to optimize opportunity while minimizing risks • Conduct a site risk assessment: Things to consider regardless of • FDA, ICH and International standards vs country specific regulations, who’s looking guidances and practices • Discover red flags that your site is entering dangerous waters and • Comparison of quality issues between the US and emerging countries get them back on course • Complexities of vendor selection when working across the globe and • Tell when a site is truly non-compliant versus sloppy and how to with different cultures approach each issue appropriately • Key factors to consider when overseeing teams at global or local • Deal with investigator non-compliance CROs in emerging countries DistinguisheD WORkshOP leaDeRs: • What can be done to prevent compliance related issues during the conduct of a study christine Pierre, President, RX tRiAlS • General inspection readiness for sponsors and sites, covering India, liz Wool, ccRA, cMt, President & ceo, QD-QuAlitY AND tRAiNiNG China, Argentina and Tanzania SolutioNS, iNc.; Member, Board of trustees, Association of clinical Research Professionals (AcRP) DistinguisheD WORkshOP leaDeRs: Sandra SAM Sather, MS, BSN, ccRA, ccRc, cliNicAl PAtHWAYS, llc Munish Mehra, PhD, Managing Director, GloBAl DRuG DeVeloPMeNt eXPeRtS Sharon luzie, Head, Quality Monitoring & compliance, JoHNSoN & JoHNSoN Dr. Helen Q. li, emerging Market QA-Asia lead, PFiZeR MeDicAl QuAlitY ASSuRANce 3:00 30-Minute Break Val Mikhailovski, Head Global clinical Quality & compliance, Global 5:00 workshop Concludes clinical Research & Development, NoVARtiS VAcciNeS & DiAGNoSticS10:00 30-Minute Break12:00 workshop Concludes; luncheon for Morning workshop delegates MAIn ConFEREnCE DAY onE • Tuesday, April 5, 20117:30 Registration and Morning Coffee 9:15 PANEl dISCUSSION Industry Response to Regulatory Agency Changes: driving the8:00 CHAIRPERSONS’ wElCOME Business in the New Enforcement Environment William Woodward, former VP, Global compliance and training, Our panel addresses: WYetH PHARMAceuticAlS • Changes in industry compliance practices resulting from changes at FDA Monjit Summy, MRPharmS, DMS, Head of Global R&D QA, and EU health authorities SHiRe PHARMAceuticAlS • Is your current risk-based model appropriate? What approach should you use?8:15 FdA KEyNOTE AddRESS • Utilizing Quality by Design as a risk management approach • The types of approaches sponsors and providers taking with over- Update on Current Enforcement Initiatives and guidance on Current sight: Are there collaborative approaches that have worked? gCP Challenges • Response to the FDA’s Final Rule governing safety analysis and reporting The current FDA administration under the leadership of Margaret • New challenges in the differing environments of clinical and pharma- Hamburg has vowed to create a strong agency that supports compli- covigilance ance via effective enforcement. However, as clinical trials continue to • Where should industry focus its resources? grow in complexity and size and are often conducted across the globe MODeRatOR: in emerging countries, what level of compliance is acceptable versus Annette Horner, Senior Director, clinical compliance, coMPliANce unacceptable? Is 100% GCP compliance an expected standard or an iMPleMeNtAtioN SeRViceS (ciS) unattainable ideal? Our presenter provides an update on: Panelists: • DSI’s risk-based approach to inspections terrance J. Stevens, Director, cQA, ARRAY BioPHARMA • Providing an acceptable response to an FDA 483 or Warning Letter: What has and has not been deemed acceptable Joanne Spallone, Global Head, Audit, clinical Quality Assurance, • Protocol deviations/violations: What is serious and what may be uSeH, NoVARtiS PHARMAceuticAlS coRPoRAtioN acceptable Janice B. Wilson, PhD, Vice President corporate Quality Assurance, • FDA’s current efforts in assessing oversight of CROs by sponsors BioNeurology, elAN PHARMAceuticAlS, iNc. • The FDA/EMA Pilot Program Mark Behm, Director compliance Advice & Assurance, clinical Ann Meeker-o’connell, MS, consumer Safety officer, office of Quality and capability Development, AStRAZeNecA compliance, cDeR, FDA 10:15 Networking and Refreshment Break
  4. 4. BREAKOUT SESSIONS: CHOOSE A OR BA: Quality Management B: Risk Management and Metrics10:45 CONTINUOUS IMPROvEMENT OF gCP QUAlITy – ESTABlISHINg A 10:45 QUAlITy RISK MANAgEMENT IN gCP ANd PHARMACOvIgIlANCE: lEARNINg ORgANIzATION THE NEw PARAdIgM This session focuses on: Our speaker discusses the general principle of Quality Risk Manage- • How to develop robust process standards, monitor processes and ment (QRM) in GCP and PV, how it works and what regulators are establish significant key performance indicators currently saying about it. He also covers strategic risk management in • Deploy risk analysis to proactively identify potential compliance is- GCP and PV with governance model and processes, including obtain- sues and establish quality indicators ing senior management support. Finally, tools are highlighted which • Implement quality in clinical trials by design can be used in QRM, such as automated tools that pull data from • Define a transparent CAPA system with input from all sources and systems, calculate risk according to set algorithms or questionnaires, clearly defined accountability and probe in a standardized way into the processes to reveal the risks • Apply systematic and timely root cause analysis lying below. • Utilize automated and centralized documentation to support knowl- Dr. Peter Schiemann, Global Head, Quality Risk Management, clinical edge sharing Quality Assurance, F. HoFFMANN-lA RocHe ltD. • 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. KG Daniel 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 11:30 UTIlIzINg STANdARdIzEd ClINICAl TRIAl PERFORMANCE METRICS QA ANd ClINICAl TO dRIvE QUAlITy MANAgEMENT IN ClINICAl TRIAlS This session presents an approach to development of a highly In this session, presenters discuss a collaborative effort to develop integrated model of collaboration between Clinical Quality Assurance and utilize standardized clinical trial performance metrics, including and Clinical Development that supports implementation of a Quality quality metrics, to drive process improvement and quality management Systems Management approach to the clinical development process. of clinical trials. Our speakers discuss: After this session attendees should be able to: • Standardized performance metrics aimed to improve efficiency and • Describe an integrated model for collaboration between Clinical delivery of clinical trial operations Quality Assurance and Clinical Development • Study start-up and study conduct quality scoring tools that evaluate • List several key components necessary to implement clinical Quality protocol writing, site selection and site performance with an aim to Systems Management in the clinical development environment balance the quest for short-term speed against the need to run an • Discuss the roles of Clinical Operations and Clinical Quality in the efficient, high quality trial Quality Systems Management model • Opportunities to participate in a MCC member metrics benchmarking • Describe potential benefits to the QA-Clinical relationship and database overall program quality through the implementation of clinical Quality Guy Mascaro, President, MetRicS cHAMPioN coNSoRtiuM (Mcc) Systems Management Jeanne Green, chair, Mcc Process improvement / Quality, Donna edgerton, Senior Director, clinical Quality Standards QA, Management Working Group, MetRicS cHAMPioN coNSoRtiuM MilleNNiuM: tHe tAKeDA oNcoloGY coMPANY (Mcc) Karen Brennan, VP, clinical operations, MilleNNiuM: tHe tAKeDA oNcoloGY coMPANY12:15 luncheon 2:30 INCORPORATINg gCP INSPECTION REAdINESS FROM dAy ONE OF yOUR PROjECT1:30 FEATUREd AddRESS There are elements of your quality plan which must be built into the How Sponsors and Providers Can Operationally Address FdA project at the outset (e.g., monitoring plan), rather than being the Requirements and Initiatives through a Quality Systems Approach last thing to organize at the end of a trial. Although there is no formal Our FDA speaker returns to follow up her keynote address with practi- requirement to have certain processes in place, you must be able cal industry advice including: to articulate your quality system and your risk management strategy • The range of acceptable monitoring practices for clinical trials, throughout a trial. Our speaker covers: including monitoring as part of sponsor’s larger, risk-based quality • How to define and mitigate your risks early on in the trial oversight • How to organize your documents before an inspection • CTTI update: Leveraging existing data and new technology (EDC) • The type of escalation process you should have to inform monitoring strategies, central approaches to clinical trial • How to effectively interact with the FDA: Dos and Don’ts oversight, and monitoring and quality plans • How to substantiate process improvements with documentation: Can • How clinical trial oversight and R&D compliance may fit within a you tell the complete story to the regulators? larger enterprise-wide compliance program • How to help prepare your sites for a successful interaction with a • Systems or processes the FDA observes during audits that may be regulatory agency best practices • How to provide effective CAPA without overcommitting corrective • Clinical trials disclosure under FDAAA, Title VIII action and timelines Ann Meeker-o’connell, MS, consumer Safety officer, office of J. Michael Sobczyk, Director, Global clinical Quality, BioGeN iDec compliance, cDeR, FDA 3:30 Networking and Refreshment Break
  5. 5. BREAKOUT SESSIONS: CHOOSE A OR BA: Quality Management B: Risk Management and Metrics4:00 CAPAS FOR gCP: A SUMMARy OF Exl’S jANUARy 2011 ClINICAl 4:00 SITE SURvEy RESUlTS! IMPACT OF INvESTIgATOR SITE METRICS CAPA CONFERENCE ON SPONSORS Our speaker presents a recap of the lecture, case study, round- With the change afoot in the monitoring model, who is ensuring your table discussion and interactive exercise presented at our January sites are GCP compliant? Our speaker delivers results from a 2010 18-19, 2011 conference, meant to move our grasp of corrective and survey of over 100 sites where 80% have been in the site business for preventive actions in the GCP environment an important step forward, 5 plus years. Information was collected on staffing, payments terms to ultimately to support your company’s overall clinical quality efforts. The investigators, ROI for coordinators and site’s current practices regard- GCP arena has come to a crossroads wherein processes must be put ing compliance and quality assurance at their sites. These metrics in place to correct current problems and demonstrate that the problem will provide useful information sponsors need to know in order to has indeed been fixed. In addition, processes must be designed to effectively assess sites’ compliance programs and best practices that prevent the problem from recurring. He reviews: should be employed to build successful relationships with their sites. • CAPA action items for clinical development christine Pierre, President, RxtRiAlS • Current challenges of CAPA implementation • Summary of regulatory expectations • Industry examples William Woodward, former VP, Global compliance and training, WYetH PHARMAceuticAlS5:00 INTERACTIvE ROUNd TABlE dISCUSSIONS Choose your preferred topic and discuss in an intimate setting. At- “Thank you very much for this excellent tendance per table is limited. You will be asked for your selection when you register. conference. The lively discussions around 1. Optimizing Training of QA Staff at Sponsors and Service Providers 2. Gaining Support of Senior Management to Obtain Additional Staff the presentations were really beneficial.” and Resources –Dr. Sabine Schäfer-Preuß, Senior International 3. Ensuring Quality in the Virtual Environment Training Manager, lOC Coordination and Training, 4. Clinical Vendor Oversight 5. The Link between Clinical Data Integrity and Product Promotion: NYCOMED GMBh Confirming Claims Are Substantiated with Robust Clinical Data 6. Open Table If you would like to suggest a roundtable discussion topic please email Program Director, Pam Sobotka at day One Concludes MAIn ConFEREnCE DAY TWo • Wednesday, April 6, 20117:45 Morning Coffee 9:30 EMA UPdATE: OvERvIEw OF EMA INSPECTIONS ANd COllABORATIvE EFFORTS wITH THE US FdA8:15 CHAIRPERSONS’ OPENINg REMARKS ANd RECAP OF dAy ONE The FDA and EMA are currently working on building a mutual under- William Woodward, former VP, Global compliance and training, standing of their GCP inspection processes utilized in the EU/EEA and WYetH PHARMAceuticAlS US through the sharing of information and cooperation in the conduct Monjit Summy, MRPharmS, DMS, Head of Global R&D QA, SHiRe of inspections. The point is not necessarily to agree on the findings PHARMAceuticAlS observed. Rather, the two groups are working towards detecting the same findings in their inspections in order to come to the same conclu-8:30 ACHIEvINg A COMMON gCP STANdARd IN INTERNATIONAl sion. Our presenter addresses: • Explanation of EMA’s process-based inspections ClINICAl TRIAlS: ETHICS, QUAlITy, ANd COMPlIANCE • Inspection procedures, combining investigator sites and sponsor site • US and European expectations for GCP in international clinical trials inspections • The ICH and WHO attempts to standardize GCP across countries and • Definitions of what are “critical” or “major” or “minor” observations regions european Regulatory Authority invited • GCP in emerging countries: national interests trumping international standards 10:15 Networking and Refreshment Break • 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:, 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) To Register: Call 866-207-6528 or visit us at
  6. 6. BREAKOUT SESSIONS: CHOOSE A OR BA: Global Inspectional Approaches B: Risk Management and Metrics10:45 A PRACTICAl APPROACH TO MANAgINg INSPECTIONS By THE MHRA 10:45 PROTOCOl COMPlExITy AS A FACTOR IN RISK MANAgEMENT Our speaker, who manages MHRA inspections at Shire Pharmaceuticals This session reviews how protocol complexity adds to operational and in the United Kingdom, provides first-hand information on: compliance risk in clinical trials. Strategies to minimize complexity are • Experiences with MHRA inspections in the UK and lessons learned discussed and the need for proactive risk management explored. from both GCP and PV perspectives Elements of complexity our speaker covers include: • How is the MHRA checking for adequate oversight of trials? • Size of the clinical trial • Update on the regulation on Breach of GCP and subsequent reporting • Multiple primary/secondary endpoints requirements • Protocol requirements that deviate from institutional standard(s) of care • Examples of what is most commonly focused on and commented on • Confirmation of eligibility by central review during inspections • Progression free survival as a primary endpoint • Planning and preparation for inspections • Dose adjustment/titration requirements Monjit Summy, MRPharmS, DMS, Head of Global R&D QA, SHiRe Marta Fields, Director, clinical Quality Assurance, SeAttle GeNeticS PHARMAceuticAlS 11:30 KEy PERFORMANCE INdICATORS (KPIs), KEy QUAlITy INdICATORS11:30 BUIldINg THE gCP FOUNdATION FOR ClINICAl TRIAlS IN ASIA (KQIs) vERSUS KEy RISK INdICATORS (KRIs): HOw TO Following the 2007 overhaul of the State Food and Drug Association dIFFERENTIATE ANd UTIlIzE FOR TRENdINg ANd ANAlySIS of China (SFDA), new provisions were put in place to strengthen over- Whether called KQIs or leading/lagging indicators, there is a consen- sight of drug safety. Our presenter worked closely with PhRMA, US sus that metrics should be collected and utilized to change an existing FDA Regulators and Asian regulatory officials in 2009 to help build the behavior for the better. Setting up a metrics program and then using foundation of the GCP environment in Asia. This presentation updates the metrics effectively can mean the difference in future successes in us on this effort and specifically offers information and insight into: our changing regulatory environment. Our panel discusses: • Setting standards for the acceptance of global data • Trending audit findings, resulting in a risk management approach • Specific GCP efforts with Asian regulatory authorities • How to monitor critical and major observations • Efforts ensuring success • The difference between KPIs, KQIs and KRIs with examples Dr. Helen Q. li, emerging Market QA-Asia lead, PFiZeR MeDicAl Panelists: QuAlitY ASSuRANce 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 & JoHNSoN12:15 luncheon1:30 HEAlTH CANAdA’S gCP COMPlIANCE PROgRAM Do You Want to Reach the Audience at This Event? • History of the program • Inspection planning • Site selection • Inspection process • Updated trends and commonly found observations Alicja Kasina Phc, MSc, Drug Specialist, GcP compliance unit, HPFB If you are interested in: inspectorate, HeAltH cANADA • Reaching a senior-level audience (Director level and above) of Clinical QA and2:15 PANEl dISCUSSION Compliance professionals at pharma and biotech companies (those professionals who Optimizing the Expanding Role of Monitoring with varied Approaches: impact their companies’ decision to partner with you via their qualification audits) A debate Recent warning letters and compliance trends suggest that monitoring • Reaching sponsor-side Clinical Operations professionals (Manager level and above, activities and monitoring reports are failing to detect and identify criti- who work hand-in-hand with QA to oversee the quality of your work and help make 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 the outsourcing decision) a new approach to monitoring activities. However, one size does not fit • Showcasing your company’s stellar audit/inspection record to influence future partner- all. Our panel presents different approaches and tools for monitoring and debate their effectiveness and efficiency depending on the size ing decisions and type of company utilizing them. MODeRatOR: • Draw attention to your company’s tools, processes, or software, that offer sponsors carol Bognar, Senior Director, GcP Services, tHe WeiNBeRG GRouP confidence in the quality of your work Panelists: . . . you should consider being part of this important conference. Sabrina comic-Savic, Senior Director GcP, R&D, tHe MeDiciNeS coMPANY Maximize your marketing dollars by exhibiting, or increase your exposure Maggie Ayers, BSc, Director, clinical Study Management, Global clinical Science, AStellAS PHARMA GloBAl DeVeloPMeNt, iNc. even further by sponsoring a cocktail reception, luncheon or breakfast. Sharon luzie, Head, Quality Monitoring & compliance, JoHNSoN & To learn more about these marketing opportunities, please call Business JoHNSoN development Manager, lucas Carrasco at 212-400-6231; E-mail at3:00 Conference Concludes
  7. 7. Conference Conference Support from:Partner: ACRP is the primary resource for clinical research professionals in the phar- maceutical, biotechnology and medical device industries, and those in hospital, Compliance Implementation academic medical centers and physician office settings. ACRP was founded in Services (CIS) is a consulting 1976 to address the distinct educational and networking needs of research nurses and others who supported firm specializing in compliance the work of clinical investigations. With its own professional society came the recognition of a new distinctive strategies for pharmaceutical profession – that of the clinical researcher. More than 30 years later, ACRP is a global association comprisedcompanies, from Global Clinical Research & Development of more than 18,000 individuals in over 60 countries dedicated to clinical research and development.through Manufacturing, U.S. Commercial Compliance and The Metrics Champion Consortium (MCC) is an open, multidisci-Government Programs. Founded in 2004, CIS provides its plinary, non-profit organization comprised of biotechnology, pharmaceuti-clients with a deep understanding of industry laws and cal and service provider organizations. The mission of MCC is to develop,regulations, innovative and practical applications and through a collaborative process, Performance Metrics within the Biotechnology and Pharmaceutical industrycustom solutions to establish a “Culture of Compliance” with the intent to jointly encourage performance improvement, effectiveness, efficiency, and appropriatethat is both meaningful and sustainable. levels of controls for both Sponsors and Service Providers in support of the drug development process.Our experts identify, assess and prioritize your organiza-tion’s exposure to compliance risks, subsequently devel- Additional Support from:oping and implementing risk evaluation and mitigationtechniques to ensure adherence to legal and regula-tory requirements.Five Ways to Register group discount Program: Discounts cannot be combined; Early Bird Rates do not apply; All discounts are taken from the standard rate.FAx: 888-221-6750 Save 25% per person when Registering FourMAIl: Exl Events, Inc. For every three simultaneous registrations from your company, you will 555 8th Ave, Ste 310 receive a fourth complimentary registration to the program (must register New York, NY 10018 4 at one time). This is a savings of 25% per person. Save 15% per person when Registering ThreePhONE: 866-207-6528 Can only send three? You can still save 15% off of every registration. To findONlINE: out more on how you can take advantage of these group discounts, please call 866-207-6528.EMAIl: 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 Registration Fees for Attending Exl’s payments are due 2 weeks prior to the event. Registrations after March 21st 2nd annual Proactive gCP Compliance: require immediate payment. Cancellations: If you need to cancel your registration for an upcoming ExL EARlY BIRD PRICING conference, please note the following policies derived from the Start Date of Register by February 25th, 2011: the event: Conference + Both Workshops $2195 Four weeks or more: A full refund (minus a $95 processing fee), or a voucher Conference + One Workshop $1995 to another ExL event valid for two years from the voucher issue date. Conference Only $1695 Four weeks or Less: A voucher to another ExL event valid for two years from the voucher issue date. STANDARD PRICING To receive a refund or voucher, please fax your request to 888-221-6750. Register after February 25th, 2011: Please Note: Conference registrations may be transferred to other colleagues Conference + Both Workshops $2395 in the event you are unable to attend. There will be an administrative charge Conference + One Workshop $2195 of $300 to substitute, exchange and/or replace attendance badges with a Conference Only $1895 colleague occurring within five business days of any ExL conference. Please notify ExL Pharma,, prior to the event with the ONSITE PRICING name and contact information of the replacement attendee. Conference + Both Workshops $2495 Please Note: Speakers and agenda are subject to change without notice. In Conference + One Workshop $2295 the event of a speaker cancellation, every effort to find a suitable replacement Conference Only $1995 will be made. *The opinions of this faculty do not necessarily reflect those of the companiesInquire about our Full-Time Academic and Government Rates – call 866-207-6528 they represent nor ExL Events, Inc.*
  8. 8. Registration Form Method of Payment: ❑ Check ❑ Credit Card Make checks payable to ExL Events, Inc. Card Type: ❑ MasterCard ❑ Visa ❑ Discover ❑ Amex Mail: Exl Events, Inc. Phone: 866-207-6528 555 8th Ave, Ste 310 Fax: 888-221-6750 Card Number New york, Ny 10018 Email: Online: Exp. Date Name on Card Signature yES! Please Register me for the: ❑ Conference AND Workshop A ❑ Conference AND Workshop B ❑ Conference AND Both Workshops ❑ Conference Only 555 8th Avenue, Suite 310 New York, NY 10018 Please contact me: PlEASE MENTION PRIORITY CODE: P1309 ❑ I’m interested in marketing opportunities at this event ❑ I wish to receive email updates on Exl Pharma’s upcoming events Name Title Company Dept. Address City State Zip Email Telephone Benchmark your Clinical Compliance Strategy 2nd annual Proactive GCP with the Following Companies on Our Faculty:Proudly ARRAY BIOPhARMA NOVARTIS PhARMACEUTICAlSPresents: ASTEllAS PhARMA CORPORATION ASTRAZENECA NOVARTIS VACCINES CoMPlIAnCE & DIAGNOSTICS BIOGEN IDEC PFIZER BOEhRINGER-INGElhEIM SEATTlE GENETICS ElAN PhARMACEUTICAlS ShIRE PhARMACEUTICAlS F. hOFFMANN-lA ROChE lTD. ThE MEDICINES COMPANY JOhNSON & JOhNSON Building in Quality to Meet New Requirements MIllENNIUM: ThE TAkEDA ONCOlOGY COMPANY and Ensure Patient Safety PlUS! Hear from: April 4-6, 2011 • westin Arlington gateway • Arlington, vA ClINICAl PAThWAYS, llC METRICS ChAMPION COMPlIANCE IMPlEMENTATION CONSORTIUM NEw FOR 2011! Take advantage of SERVICES, INC. FDA QD-QUAlITY AND TRAINING SOlUTIONS, INC. • Assessing site compliance and improving in-depth half-day GlOBAl DRUG DEVElOPMENT RxTRIAlS site quality ExPERTS STRATEGIC INITIATIVE FOR • Risk-based approaches to compliance workshops on: GOOD ClINICAl PRACTICE DEVElOPING CAPACITY IN AllIANCE – EUROPE (GCPA) EThICAl REVIEW (SIDCER) • Building a cooperative relationship between • Achieving gCP Compliance ThE WEINBERG GROUP hEAlTh CANADA QA and Clinical Operations in Emerging Countries • New approaches to monitoring activities • Ensuring your Site Partners Conference With Support from: • Minimizing protocol complexity are gCP Compliant Sponsor: • More time to interact with the FdA! To Register: Call 866-207-6528 or visit us at