Best Practices for Maintaining Continuous Compliance on a Global Scale. August 12-13, 2014 Sonesta Hotel Philadelphia Philadelphia, PA

Transcription

1 3 rd Clinical Trials Inspection Readiness Summit August 12-13, 2014 Sonesta Hotel Philadelphia Philadelphia, PA Top Reasons to Attend Only conference in the industry that is exclusively GCP-focused rather than GMP regarding inspection preparation Deep-dive analysis into regulatory criteria needed to remain compliant during a clinical inspection Excellent knowledge and sharing of inspections and inspection readiness across the globe Senior Specialist, GCP Compliance, Merck Best Practices for Maintaining Continuous Compliance on a Global Scale Presenting Over 15 Compelling Case Studies for 2014 Covering: CRO Management Regulations Updates Global Perspectives Provides industry leaders with proactive strategies shared through case studies designed to prepare their investigators for an inspection throughout an entire clinical trial CROs will share procedural tips on how to prepare sites for auditors Learn from industry professionals on how they prepare for a clinical inspection Trial Master Files Pharma covigilance Inspection Readiness Led by Our Expert Speaking Faculty: Inspector s Views Dawn Wydner, Senior Director Americas, R&D Regulatory Compliance, Janssen, Former FDA Investigator Mary Ann Battles Director Clinical Quality Assurance, Clinical Quality Standards, Millennium J.P. Miceli Senior Manager, Clinical Documentation, Vertex Val Mikhailovski Director Clinical Compliance, Abbvie Peggy Siemon-Hryczyk, Group Director, Clinical Ops, Project Management, Biometrics and Data Management, Eisai Sandy Shire, DMD, MPA, CAPT (Ret) USPHS, Associate Director, Interprofessional Programs, Clinical Associate Professor, Arizona State University, Former FDA Investigator sponsor: Deborah Twombly Senior Clinical Auditor Officer, Alkermes Ivan Walrath TMF Business Process Owner, Pfizer Stephanie Zafonte Director Clinical Project Management, NIAID Craig Duffy Supervisor, Clinical Logistics-Clinical Drug Supply, Biogen IDEC To Regis

2 Dear Colleague, Inspections can occur at any time and you need to be ready to act. The consequences of a failed inspection can be dire including hefty fines, lost jobs and waning credibility for a project. Inspection readiness is not just a one time event. In fact, the inspection readiness process is driven by people who excel at thinking ahead and take into account the constantly evolving variables of clinical research; Including new staff, new sites and new vendors. Thinking about problems that could arise during an inspection is the key to maintaining continuous compliance at clinical trial sites and ensuring that all systems are a go. The 3rd Clinical Trials Inspection Readiness Summit presents life science industry professionals sharing case studies of how to put into place proactive measures to reduce the risk of a failed inspection. Effective clinical research documentation, FDA submissions, TMF processes and vendor management are critical to audit preparation. The professionals we bring together are the thought leaders who are elevating inspection readiness to a higher plane. Additionally this summit will provide you with a space not only to learn, but also to network and bring your top of mind challenges directly to former inspectors and leaders in this space. 13% 7% 15% 15% 10% 5% 15% Attendee Profile: 50% 70% Clinical operations Compliance Quality R&D Other Company Profile: Pharma/ Biotech/ Medical Device CRO Technology Vendor Consultant This years Summit Will Feature Six Interactive Case Study Presentations on Ways to: Identify what an Inspector is Looking For During an Audit Implement Inspection Readiness at a Sponsor Company Enhance the Sponsor and CRO Communication and inspection preparedness Prepare for an Inspection from the EMA Implement etmf in Large Scale Studies Streamline Inspection Readiness Through Airtight Written SOP s and Team Training I look forward to meeting you in Philadelphia this August! Sincerely, Natasia Langfelder Natasia Langfelder Conference Production Director, 3rd Clinical Trials Inspection Readiness Summit nlangfelder@exlpharma.com Scott Grossman Scott Grossman Conference Production Team Leader sgrossman@exlpharma.com What Your Colleagues are Saying about ExL s Inspection Readiness Series: A lot of learning based on presenter and peer experience Lead Advisor, Astrazeneca Great-speakers were excellent! Director Clinops, Tarsa Information was very well presented and valuable Sr. Training Specialist, Janssen Who Should Attend: Professions in the life sciences industry with responsibilities in the following areas: Clinical Quality Assurance/Control/Compliance Global Compliance/Quality Management/ Regulatory Affairs Clinical Operations/Affairs Safety & Risk Management/Operations Auditing Clinical Monitoring/Research Clinical Site Management/Project Management/Document Coordination Clinical Trials Trial Master Files Pharmacovigilance This program is also of interest to clinical QA/ compliance professionals involved with: CROs Institutional Review Boards Investigative Sites Data Management/Computer Software Consulting Firms presentations were relevant and sufficiently detail appropriate for an experienced audience Deputy Director, Sanofi This has been the best conference I have ever attended. The speakers have all been great and the use of humor in several presentations is a welcome relief to information that is often tedious. CCRP, Mayo Clinic Very effective, well delineated VP BD, Phlexglobal Perfect size, good location, good content Principal, Alpha Prime Consulting Network with: Life Sciences Companies Clinical Operations Professionals Compliance and Quality Professionals To Regis call

3 AGEnda Day 1 Tuesday August 12, :15 Registration Opens & Continental Breakfast 8:45 Chairperson s Opening Remarks 9:00 The Inspector s View: What Inspectors are Looking for During an Inspection A history of how the FDA inspection regulations have evolved over time from a former FDA investigator What the inspector really looks at and they they do during a full process inspection Learn which sponsor mistakes are the most commonly made Explore the future trends in this space Sandy Shire, DMD, MPA, CAPT (Ret) USPHS, Associate Director, Interprofessional Programs, Clinical Associate Professor, Arizona State University, Former FDA Investigator The Inspector s View 9:45 tmf Inspection Preparedness and Security Using Quality Checks, Monitoring, and Audits Identifying five different ways you can provide content to an inspector Being prepared to reveal your internal inspection process itself as a potential object of audit Putting protection in place to keep information secure when sharing information and being prepared to demonstrate this protection to regulators Ivan Walrath, TMF Process Owner, Pfizer 10:30 Build your TMF Inspection Preparedness Timeline Learn what needs to be done and when to do it Start-up considerations when creating the QC plan Conduct periodic reviews; how often should they take place and who s responsibility is it? Close-out responsibilities, end of study QC and final reconciliation Toni Lakin-Ritter, Business Development Manager, PhlexGlobal J.P. Miceli, Senior Manager, Clinical Documentation, VERTEX 11:00 networking and Refreshment Break 11:30 streamlining Inspection Readiness Through Airtight Written SOP s and Team Training Ensuring written Standard Operating Procedures are clear, in alignment with FDA regulations and allow for easy access of files during audit Training staff to ensure knowledge and implementation of SOPs are practiced Lessons learned from the rollout of recent product launches Proactively identify process/procedural/systems gaps and implement continuous improvement solution Craig Duffy, Supervisor, Clinical Logistics-Clinical Drug Supply, Biogen Idec 12:30 Luncheon 1:30 Customizing Off the Shelf Solutions to Prepare an Inspection Readiness Regime that works for you What you need to put into your inspection readiness template Unique and necessary tools for success How to best allocate resources during this process for maximum results Lisa Murphy, Associate Director, Quality Standards, R&D Compliance, Biogen Idec 2:00 strategies to Build and Maintain Effective Sponsor & CRO Communication Learn important selection criteria that goes into choosing which CRO to partner with Communication methods and chain of command that must be established to avoid playing telephone SOW change to support the Sponsor s inspection readiness activities and to be available (on call) in the event of an inspection Strategies to build a long-lasting and profitable working relationship Peggy Siemon-Hryczyk, Group Director, Clinical Ops, Project Management, Biometrics and Data Management, Eisai 3:00 examining Protocol Adherence for Sites and Sponsors Harmonize Terminology Adapt to changes in the Regulatory landscape Ensure that the information you are submitting is accurate and reflects site/sponsor actions Do you consider a Note to File a fix? Know when training/retraining is the answer Stephanie Zafonte, Director Clinical Project Management, NIAID 3:30 afternoon Networking Break 4:00 Best Practices for Inspection Readiness Resource Management & Budgeting How to assess inspection readiness of your key vendors remaining compliant is a costly process and budgets must be carefully balanced Learn how to best allocate limited resources Strategies for obtaining additional resources and funds through increased corporate buy-in Deborah Twombly, Senior Clinical Auditor Officer, Alkermes 4:30 panel Discussion: Ensure a Symbiotic Sponsor- Vendor Relationship from the Beginning Through Inspection Management Manage rising costs of clinical trials through vendor sourcing and negotiation How to handle changing technology outsourcing Perspective from small companies that rely heavily on outsourcing Moderator: Valerie Wilkins, Associate Director, Clinical Quality Assurance, Novartis Lisa Murphy, Associate Director, Quality Standards, R&D Compliance, Biogen Idec Stephanie Zafonte, Director Clinical Project Management, NIAID 5:30 Conclusion of Day One To Register please visit or call

4 AGEnda Day 2 Wednesday August 13, 2014 The Inspector s View 8:15 Continental Breakfast 8:45 Chairperson s Recap of Day One 9:00 The Inspector s View: Implement an Inspection Readiness Process Lessons learned in inspection readiness from a former inspector who audited over 155 facilities Hear which best practices that have been implemented at Jansen as a result of what would have been asked for during an inspection Leverage new technologies and techniques to be able to provide inspections 100% of the documents they need in as little as two days Learn proactive strategies to ensure a continued state of inspection readiness Dawn Wydner, Senior Director Americas, R&D Regulatory Compliance, Janssen, Former FDA Investigator 9:30 Maintaining Inspection Ready Sites in Emerging Markets Develop an action strategy for managing clinical trial sites in China, Africa, India and other developing markets Explore the difference in regulatory guidelines in order to tailor SOPs for each site Navigate the vendors in this space and appropriate criteria for selection Adapt to cultural differences and time zones to ensure harmony Val Mikhailovski, Director Clinical Compliance, Abbvie 1:00 Panel Discussion: Crucial Preventative Measures for Managing Global Sites Leverage new technology to manage overseas teams Manage risk through effective communication techniques Assemble the correct team to oversee international sites Techniques to train and maintain a staff you can rely on Panelists: Nehal Bhatt, Head QMS Compliance, Teva Pharmaceuticals Val Mikhailovski, Director Clinical Compliance, Abbvie Sophie Moya, Quality Assurance Manager, Guerbet Group 1:30 Panel Discussion: Learn From Past Mistakes: Steps to Take After Receiving a Warning Letter Panelists share their lessons learned in the wake of receiving a warning letter What steps were taken in regard to vendor management How on-site staff were trained to better manage risk going forward DeVaughn Edwards, Director of Quality Operations/Compliance, Johnson & Johnson Mary Ann Battles, Director Clinical Quality Assurance, Clinical Quality Standards, MILLENNIUM 10:00 International Spotlight: Preparing for an Inspection from the European Medicines Agency A unique case study of inspection readiness preparation in France Explore the difference in GCP and GMP inspections in the EU Address the challenges arising from the globalization of clinical research Discuss the implications of the joint FDA/EMA initiative on inspections for generic applications Sophie Moya, Quality Assurance Manager, Guerbet Group 11:00 networking and Refreshment Break 11:30 Case Study: Implement etmf in Large Scale Studies Vertex Pharmaceuticals implemented three late stage all etmf studies to gauge the efficiency of switching to a paperless system Learn what worked and what didn t work and which metrics to use to benchmark progress Proper budget management and resource allocation for an etmf system Addressing culture change J.P. Miceli, Senior Manager, Clinical Documentation, Vertex 12:00 Luncheon 2:30 the Rise of Pharmacovigilance: Looking at Pharmacovigilance s Increased Importance and Regulations Changes Discuss global requirements for good pharmacovigilance practice Explain the impact of the latest US and European regulations on international safety reporting and review methods Describe the challenges sponsor companies face when complying with foreign safety regulations Create a checklist of good pharmacovigliance audit practices Swati Tendolkar, Program Manager, Global System Quality Assurance, Johnson & Johnson 3:00 managing Risk Through Creating a Culture of Continuous Compliance Learn how J&J rolled out a policy that supports Inspection Readiness at all times How the policies were developed and which metrics were used to judge effectiveness Successful roll-out, including at overseas trials Dirk Gille, VP Head Pharmaceutical R&D QAVP Head Pharmaceutical R&D QA, Johnson & Johnson 3:30 Chairperson Closing Remarks 3:45 Conference Conclusion To Register please visit or call

5 Media Partners VENUE: Pricing Info: Early Bird Pricing Register by June 27th, 2014 $1,895 Standard Pricing $2,095 Onsite Pricing $2,195 GROUP DISCOUNT PROGRAMS Offers cannot be combined, early bird rates do not apply. To find out more on how you can take advantage of these group discounts, call 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). Save 15% per person when registering three Can only send three? You can still save 15% off of each registration. Sonesta Hotel Philadelphia 1800 Market Street Philadelphia, PA Phone: (215) The Sonesta Hotel Philadelphia offers a spectacular downtown location that is convenient to whatever brings you to the City of Brotherly Love. Located near world-class restaurants and boutique shopping at ritzy Rittenhouse Square in Center City, the hotel is within the business district and walking distance to many popular Philadelphia attractions, historic landmarks, museums and theaters. Room Reservations: To make reservations please call SONESTA and request the negotiated rate for ExL Pharma August Meetings. The group rate is available until July 21st, Please book your room early as rooms available at this rate are limited. Opportunities Do you want to spread the word about your organization s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs. To learn more about these opportunities, contact, Eric Morrin, Business Development Manager at or emorrin@exlpharma.com PAYMENT Make Please checks make checks payable payable to ExL to: Events, PMA" Inc. and write code C490 on your check. You many also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer, and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. Please note, 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. CANCELLATION POLICY If you need to cancel your registration for an upcoming ExL conference, please note the following polices derived from the start date of the event: Four weeks or more: A full refund (minus $95 processing fee), or a voucher to another ExL event valid for 18 months from the voucher issue date. Four weeks or less: A voucher to another ExL event valid for 18 months from the voucher issue date. To receive a refund or voucher, please fax contact your our request offices to at (201) or call ExL Pharma reserves the right to cancel any conference it deems necessary and will not be responsible for airfare, hotel or any other costs incurred by registrants. ExL Pharma s liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date, content, speaker or venue. TERMS AND CONDITIONS By registering for an ExL Events, Inc. ( ExL Pharma ) event, you agree to the following set of terms and conditions listed below: Registration Fee: The fee includes the conference, all program materials and designated continental breakfasts, lunches and refreshments. The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL events, Inc. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL Events, Inc. s ( ExL s ) designated speakers and is designed for informational purposes for its attendees, and is NOT INTENDED for purposed of copywriting, not redistribution to other outlets without the express written permission of ExL s designated speaking parties. Neither ExL, nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY OF THE CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of or endorse the views or opinions given by any third party content provider. ExL presentations may point to the other Internet sites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

6 Method of Payment: q Check q Credit Card q YES! Register me for this conference! Name: Title: Company: Dept: Address: City: State: Zip: Phone: Fax: Card Type: q MasterCard q Visa q AMEX Card Number: Exp. Date: Name on Card: Signature: Please contact me: q I m interested in marketing opportunities at this event q I wish to receive updates on ExL Pharma s upcoming events CONFERENCE CODE: C523 3 rd Clinical Trials Inspection Readiness Summit Excellent knowledge and sharing of inspections and inspection readiness across the globe Senior Specialist, GCP Compliance, Merck Best Practices for Maintaining Continuous Compliance on a Global Scale August 12-13, 2014 Sonesta Hotel Philadelphia Philadelphia, PA r s Views Dawn Wydner, Senior Director Americas, R&D Regulatory Compliance, Janssen, Former FDA Investigator Sandy Shire, DMD, MPA, CAPT (Ret) USPHS, Associate Director, Interprofessional Programs, Clinical Associate Professor, Arizona State University, Former FDA Investigator Top Reasons to Att Only conference in the industry that is exclusively GCP-focused rather than GMP regarding inspection preparation Deep-dive analysis into regulatory criteria needed to remain compliant during a clinical inspection Provides industry leaders with proactive strategies shared through case studies designed to prepare their investigators for an inspection throughout an entire clinical trial CROs will share procedural tips on how to prepare sites for auditors Learn from industry professionals on how they prepare for a clinical inspection