Organized by: TOP REASONS 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 To regisTer, please visiT www.worldcongress.com/rbm • phone: 800-767-9499 • Fax: 781-939-2543 • email: [email protected]January 27-28, 2015 | wyndham philadelphia hisToric disTricT | philadelphia, pa 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 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 assess, conTrol, review, and adJusT risk across The Trial liFecyle The World Congress Summit on Risk-Based Monitoring and the Quality Risk Management of Clinical Trials People Process Technology RBM Media Partners Organized by save up To $600 when you regisTer by Friday, december 12, 2014! PLUS a Pre-Conference Workshop on: Integrate, Analyze, & Plan Your QRM Strategy
Transcript
Organized by:
T o p R e a s o n s T o a T T e n d 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
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:
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,
Brett Wilson Associate Director, Global Business Development, Operations, BRiSTol-MyeRSSquiBB TransCelerate RBM Workstream Co-Lead
Chairperson, World Congress Summit on Risk-Based Monitoring and the Quality Risk Management of Clinical Trials
P.S. Don’t forget about the team discount. Find out more about special
c o n s i d e r a s p o n s o r s h i p p a c k a g e • Present to Key Players in Your Target Market • Take Advantage of 1-on-1 Sponsor/Attendee Meetings Facilitated On-Site
CAPTURE A TRUE ROI ThROUgh SPOnSORShIP 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]
T h e W o 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
day one – Tuesday, January 27, 2015 • pre-summiT workshop7:30 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) strategyAn 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
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.
11:45 am – 1:00 pm Lunch on Your Own/Main Summit Registration
day one – Tuesday, January 27, 2015 • main summiT1:00 pm – 1:15 pm Chairperson’s Welcome
Brett Wilson Associate Director, Global Business Development, Operations BRiSTol-MyeRSSquiBB 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
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
JessicaHolthuizen Clinical Operations Head JoHnSon&JoHnSon
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 BRiSTol-MyeRSSquiBB TransCelerate RBM Workstream Co-Lead
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
Janislittle Vice President, Global Regulatory Quality AlleRgAn
Christine Pierre President SoCieTyfoRCliniCAlReSeARCHSiTeS
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 SoCieTyfoRCliniCAlReSeARCHSiTeS
Panelists: Racheledwards,BSc,Phd
Director and Regional Head for Central and Emerging Europe, Middle East and Africa, Global Study Operations AMgen
Craig Wozniak Head, Americas Clinical Operations, Therapy Area Delivery, glAxoSMiTHKline
5:45 pm – 6:45 pm Cocktail and Networking Reception
day Two – wednesday, January 28, 20157:30 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 BRiSTol-MyeRSSquiBB 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
Margaretf.fay,Phd,Rn,CCRC Director, Global Clinical Monitoring, Clinical Operations MedTRoniC,inC.
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, CoMPliAnCequAliTyinTegRATion(Cqi)ConSulTing
Panelists:
davidW.fryrear Senior Director, Clinical and Pharmacovigilance Quality Assurance, ABBVie
Kevin Douglass Associate Director, Data Management dAiiCHiSAnKyo
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
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:
devenV.Parmar,Md,fCP Director - Clinical Development PRolongPHARMACeuTiCAlS
Shailesh Chavan, MD Senior Director, Clinical Development, Drug Safety and Medical Affairs BioTeSTPHARMACeuTiCAlS
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
MarkTravers Global Head, Clinical Study Units SAnofi
2:15 pm – 3:00 pm
Interactive Q&A
Moving the needle on RBM — ask the expertsGet 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:
MarkTravers Global Head, Clinical Study Units SAnofi
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.
