The World Congress Summit on Risk-Based Monitoring and the Quality Risk Management of Clinical Trials

The World Congress Summit on Risk-Based Monitoring and the Quality Risk Management of Clinical Trials

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  S a ve u p t o $ 6 0 0 w h e n y o u r e g i s t e r b y F r i d a y, d e c e m b e r 1 2 , 2 0 1 4 ! T h e Wo r l d C o n g r e s s S u m m i t o n Risk-Based Monitoring and the Quality Risk Management of Clinical Trials Assess, Control, Review, and Adjust Risk Across the Trial Lifecyle January 27-28, 2015 | Wyndham Philadelphia Historic District | Philadelphia, PA To p R e a s o n s to Attend Drive your RBM strategy by benchmarking with early adopters Maximize results through fostering collaboration between clinical development and quality professionals Improve connectivity between the Site and Sponsor Negotiate a change management strategy across internal and external stakeholders Adapt the model and de-risk each clinical trial Establish metrics to guide risk mitigation planning Plus a Pre-Conference Workshop on: Integrate, Analyze, & Plan Your QRM Strategy Kimberly A. Wong Oleson Senior Vice President, Clinical Affairs Sunshine Heart, Inc. Christine Pierre President Society for Clinical Research Sites Mark Travers Global Head, Clinical Study Units sanofi Media Partners Organized by Organized by: People Technology Process RBM Featured Speakers include Peg Connelly Head, Portfolio Quality Risk Management Pfizer Rachel Edwards, BSc, PhD Director and Regional Head for Central and Emerging Europe, Middle East and Africa, Global Study Operations Amgen Margaret F. Fay, PhD, RN, CCRC Director, Global Clinical Monitoring, Clinical Operations Medtronic, Inc. David W. Fryrear Senior Director, Clinical and Pharmacovigilance Quality Assurance AbbVie Janis Little Vice President, Global Regulatory Quality Allergan To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: [email protected]
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  T h eWo r l d C o n g r e s s S u m m i t o n Risk-Based Monitoring and the Quality Risk Management of Clinical Trials T h i s s u m m i t o ff e r s : 20 expert speakers in clinical trial oversight and quality risk management 14 small, mid-sized, and large trial sponsor perspectives 4 clinical research site leaders 4 case studies w h o s h o u l d a tt e n d : Pharmaceutical and Medical Device Industries Clinical Operations Quality Assurance Quality Auditing Safety Data Management Study Monitoring Biostatistics Clinical Research Sites Investigator Clinical Research Coordinator Site Director Dear Colleague, Clinical trials must be conducted more safely and efficiently if patients are to benefit from new therapies in the development pipeline. Risk management throughout the product lifecycle from the study planning phase to its conclusion enables a trial sponsor to reduce or prevent risk or lessen the severity of a harmful event. Risk-based approaches, adapted to each trial, allow the Sponsor to not only address cost, but better identify, manage, and remove risk to ensure patient safety and data quality. The World Congress Summit on Risk-Based Monitoring and the Quality Management of Clinical Trials offers pharmaceutical and medical device professionals a forum where they can learn from peers and experts who are taking steps to implement risk-based monitor-ing using a quality risk management or quality by design approach to conducting clinical trials. Specific topics on the agenda include: • An end-to-end risk management model • The evolving role of the clinical quality professional in risk-based approaches • Change management strategies for people, processes and technology • How to link your risk assessment to build better protocols • RBM metrics • How to create better connectivity between the Site and Sponsor • Strategies for large, mid-sized, and small trial sponsors • Central monitoring and key enablers If you are open to adopting new practices and committed to improving the clinical trial process, you don’t want to miss this Summit. I look forward to meeting you on January 27-28, 2015 in Philadelphia. Sincerely, P.S. Don’t forget about the team discount. Find out more about special group package discounts by calling 800-767-9499 or emailing wcreg@ worldcongress.com Brett Wilson Associate Director, Global Business Development, Operations, Brist ol-Myers Squibb TransCelerate RBM Workstream Co-Lead Chairperson, World Congress Summit on Risk-Based Monitoring and the Quality Risk Management of Clinical Trials CONSIDER A SPONSORSHIP PACKAGE • Present to Key Players in Your Target Market • Take Advantage of 1-on-1 Sponsor/Attendee Meetings Facilitated On-Site CAPTURE A TRUE ROI Throu gh Spo nsors hip of the Following: Agenda Thought Leadership • Networking Cocktail Reception • Breakfast Symposia • Luncheon • Executive Networking Breaks To inquire about Sponsorship, Exhibit, Branding, and Executive Networking Opportunities, Contact: Suzanne Caroll, Manager, Business Development, World Congress • Call 781-939-2648 or email [email protected] To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: [email protected]
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  DAY ONE –Tuesday, January 27, 2015 • Pre-Summit Workshop 7:30 am – 8:30 am Workshop Registration and Morning Coffee 8:30 am – 11:45 am INTERACTIVE Workshop: Integrate, Analyze, & Plan Your Quality Risk Management (QRM) Strategy An educational, skill building workshop that offers attendees examples, and an opportunity to engage in case study group exercises, designed to enhance their capabilities to develop integrated QRM processes and assess and manage risk utilizing these principles. I. Recognize How to Integrate QRM within Clinical Quality Systems • Develop strategies to successfully integrate QRM in GCP • Apply QRM to study site management and to optimize performance • Learn how to promote QRM at the research sites • Case study group exercise II. Utilize QRM to Analyze Risk and for Action Planning • Adapt various risk assessment models to GCP • Assign risk thresholds based on systems and project specific needs • Identify effective tools to grade and score areas of risk • Build a QRM plan linked to safety, data, and monitoring study plans • Case study group exercise Interactive Session: Breakout group discussions! Sandra “SAM” Sather, MS, BS, CCRC, CCRA, Member, ACRP Academy Boar d of Trust ees a nd Regulatory Affairs Comm itt ee Ms. Sather is an industry veteran whose mission is to promote clinical quality systems worldwide for investigational sites, sponsors/ CROs and ethics committees. She has over 25 years of clinical experience with a Master of Science in Education with a specialization in Training and Performance Management. In 2002, Ms. Sather co-founded Clinical Pathways, a clinical research consulting firm located in the Research Triangle Park area in North Carolina, USA, and works with sponsors, vendors, and sites relating to drug and device trial execution. She is dual certified by the Association for Clinical Research Professionals (ACRP), serves on the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC). She is a frequent facilitator and speaker for industry projects and events. There is a 15 minute coffee and networking break from 10:00 am – 10:15 am 11:45 am – 1:00 pm Lunch on Your Own/Main Summit Registration DAY ONE – Tuesday, January 27, 2015 • main Summit 1:00 pm – 1:15 pm Chairperson’s Welcome Brett Wilson Associate Director, Global Business Development, Operations Brist ol-Myers Squibb TransCelerate RBM Workstream Co-Lead 1:15 pm – 2:00 pm Is Risk-Based Truly Risky? An Industry Perspective on Risk Based Approaches for Clinical Trial Conduct • Examine the external factors in our landscape that drive change in the way that clinical trials are conducted • Analyze the common myths about risk-based monitoring • Determine the business value of risk-based trial conduct Kimberly A. Wong O leson Senior Vice President, Clinical Affairs Sunsh ine Heart , I nc. 2:00 pm – 2:45 pm Link Your Risk Assessment to Your Study Protocol – Better Identify, Manage, and Remove Risk • Discuss the importance of having a cross-functional team • Gain insights on where the risk assessment process best benefits protocol development • Perform the risk assessment concurrent with study protocol development • Hear the latest refinements on the RACT tool and examples of how it’s been working in practice Jessica Holthuizen Clinical Operations Head Johnson & Johnson To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: [email protected]
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  DAY ONE –Tuesday, January 27, 2015 (continued) 2:45 pm – 3:15 pm Networking and Refreshment Break 3:15 pm – 4:00 pm Lessons Learned on RBM Metrics — Results from the TransCelerate Pilots • Examine lessons learned from TransCelerate pilots including measures that were developed around quality, efficiency, and cycle time • Evaluate the contribution that Source Data Verification (SDV) and review makes to clinical trial safety and data quality • Hear case examples: – metrics – SDV – Change management support Brett Wilson Associate Director, Global Business Development, Operations Brist ol-Myers Squibb TransCelerate RBM Workstream Co-Lead Case Study 4:00 pm – 4:45 pm Enhance Connectivity between the Site and Sponsor for Effective Implementation • Hear results from a Linking Leaders and SCRS survey on perceptions of the impact of RBM • Discuss the importance of transparency, education, tools, and other resources in communicating an RBM approach and methodology • Identify ways for the site and sponsor to become proactive partners to implement change Janis L ittle Vice President, Global Regulatory Quality Allergan Christine Pierre President Society for Clinical Research Sites Case Study 4:45 pm – 5:45 pm Panel Dual Perspectives — Sites and Sponsors on Achieving Alignment • Evaluate and adapt organizational structure and culture to support RBM • Negotiate a management strategy and influence change at the Sites • Address the issue of the patient’s perception and the impact of ‘risk’ versus ‘adaptive’ monitoring terminology Moderator: Christine Pierre President Society for Clinical Research Sites Panelists: Rachel E dwards, BSc, PhD Director and Regional Head for Central and Emerging Europe, Middle East and Africa, Global Study Operations Amgen Vince G illen Director, Lehigh Center for Clinical Research Yvonne McCracken Vice President, Operations and Compliance, RxTrials Jane M. Shen, PharmD Director, Strategic Relationships PMG Research , I nc. Craig Wozniak Head, Americas Clinical Operations, Therapy Area Delivery, GlaxoSmith Kline 5:45 pm – 6:45 pm Cocktail and Networking Reception DAY two – Wednesday, January 28, 2015 7:30 am – 8:30 am Morning Coffee 8:30 am – 8:45 am Chairperson’s Welcome and Review of Day One Brett Wilson Associate Director, Global Business Development, Operations Brist ol-Myers Squibb TransCelerate RBM Workstream Co-Lead 8:45 am – 9:30 am Medtronic’s Innovative End-to-End Quality Risk Management Model • Learn how quality risk management can be engineered for a successful program through the total lifecycle of trial conduct • Identify the main deliverables, processes, and systems • Hear Medtronic’s experience with implementation of QRM processes and tools Margaret F . F ay, PhD, RN, CCRC Director, Global Clinical Monitoring, Clinical Operations Medtr onic, I nc. Case Study To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: [email protected]
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  DAY two –Wednesday, January 28, 2015 (continued) 9:30 am – 10:15 am Panel Break Down the Silos between Clinical Quality and Operations Professionals for Improved Trial Execution • Outline steps to embed quality-by-design and continuous quality improvement • Define the roles between clinical and quality team members • Collectively determine areas of risk to develop an RBM strategy • Establish “quality as a culture” within the organization Moderator: Arti Bajpai President, Comp liance Quality I ntegrat ion (CQI ) Consulting Panelists: David W. F ryrear Senior Director, Clinical and Pharmacovigilance Quality Assurance, Abb Vie Kevin Douglass Associate Director, Data Management Daiich i Sankyo Peg Connelly Head, Portfolio Quality Risk Management Pfizer 10:15 am – 10:45 am Networking and Refreshment Break in the Executive Networking Lounge 10:45 am – 11:30 am How We Did It — A Site, Trial Sponsor, and CRO RBM Pilot Study • Discuss how implementation of RBM allows a site, trial sponsor, and CRO to share accountability for integrated quality and risk management • Identify criteria and outline a plan for partnering on the right trial and processes • Evaluate lessons learned and results to-date Thought Leaders TBA Case Study 11:30 am – 12:30 pm Panel Meet the Challenges of RBM Implementation for Small to Mid-Sized Trial Sponsors • Discuss the advantages and disadvantages of utilizing a risk-based monitoring strategy • Address the cost of RBM implementation in accordance with the investors’ expectations • Analyze alternative models through CRO partnerships with clinical operations Moderator: Deven V. Parmar, MD, F CP Director - Clinical Development Prolong Pharmac euticals Panelists: Jessica L ee, MS, MPH Vice President, Clinical Operations Inovio Pharmac euticals Shailesh Chavan, MD Senior Director, Clinical Development, Drug Safety and Medical Affairs Biotest Pharmac euticals 12:30 pm – 1:30 pm Luncheon in the Executive Networking Lounge 1:30 pm – 2:15 pm Facilitate Central Monitoring Methodology to Cost Effectively Prevent Risk • Evaluate technology requirements to do effective central monitoring • Hear examples of the various models that TransCelerate member companies are piloting • Learn critical people, process, and technology enablers Mark Travers Global Head, Clinical Study Units sa nofi 2:15 pm – 3:00 pm Interactive Q&A Moving the Needle on RBM — Ask the Experts Get your most pressing questions answered by a panel of experts and leave with an action plan. • Learn how to take your RBM pilot to the next level • Gain practical advice for overcoming internal hurdles in adopting a risk-based approach • Hear perspectives on what the future of risk-based trials could look like and how we should begin to prepare for the future now Moderator: Mark Travers Global Head, Clinical Study Units sa nofi Panelists: Deven V. Parmar, MD, F CP Director, Clinical Development, Prolong Pharmac euticals Additional Panelists TBA 3:00 pm Chairperson’s Closing Remarks, Close of Summit To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: [email protected]
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  S a ve u p t o $ 6 0 0 w h e n y o u r e g i s t e r b y F r i d a y, d e c e m b e r 1 2 , 2 0 1 4 ! Registration Fee: Register By 12/12/2014 Register By 1/09/2015 Register By Standard 01/27/2015 Conference $ 1795.00 $ 2095.00 $ 2395.00 Conference Plus 1 Workshop $ 1995.00 $ 2295.00 $ 2595.00 pharma & biotech Conference $ 1195.00 $ 1495.00 $ 1795.00 Conference Plus 1 Workshop $ 1395.00 $ 1695.00 $ 1995.00 Fee for conference includes welcome coffee, lunch, reception, refreshments, and web-based conference documentation available pre- and post-event, accessible through password-protected website. Checks in U.S. funds drawn from U.S. bank payable to: WC Research Inc. No personal checks accepted. Verification may be required for rate approvals. Please contact us should you have any special needs. SPECIAL TEAM DISCOUNTS: Your organization may send ONE executive FREE for every three delegates registered. All registrations must be made at the same time to qualify. To register your team, contact us at 800-767-9499. Participant Substitution and Cancellations: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or before 30 days prior to the start of the event will be refunded, less a $395 administrative charge. No refunds will be made after this date; however, the registration fee less the $395 administrative charge can be credited to another World Congress conference if you register within 6 months from the date of this conference. In case of conference cancellation, World Congress’ liability is limited to refund of the conference registration fee only. World Congress reserves the right to alter this program without prior notice. Satisfaction guaranteed: World Congress stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable World Congress conference of your choice. Register Now! E-MAIL WEBSITE WorldCongress.com/ RBM [email protected] Best Value PHONE 800-767-9499 781-939-2400 outside the U.S. PRSRT STD U.S. Postage PAID Gallery Venue: Wyndham Philadelphia Historic District 400 Arch Street Philadelphia, PA 19106 215-923-8660 Room Rate: $129 Cut-off Date: 1/5/15 World Congress 500 West Cummings Park, Suite 5200 Woburn, MA 01801 PB15017 ATTN Mail Room: If undeliverable please forward to clinical operations/study monitoring/quality assurance Please mention WC Research/World Congress when registering to receive this special rate! T h e Wo r l d C o n g r e s s S u m m i t o n Risk-Based Monitoring and the Quality Risk Management of Clinical Trials Assess, Control, Review, and Adjust Risk Across the Trial Lifecyle January 27-28, 2015 | Wyndham Philadelphia Historic District | Philadelphia, PA Featured Speakers include Janis Little Vice President, Global Regulatory Quality Allergan Jessica Holthuizen Clinical Operations Head Johnson & Johnson Peg Connelly Head, Portfolio Quality Risk Management Pfizer Craig Wozniak Head, Americas Clinical Operations, Therapy Area Delivery GlaxoSmithKline • QbD Protocol Design and Conduct • Quality Risk Management • Risk-Based Monitoring • Risk-Based Auditing • Sponsor-Site Alignment To register, please visit www.worldcongress.com/contactcenters • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: [email protected] To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: [email protected]