6th Annual Clinical Quality Oversight Forum
Start:
Mon, 5 Oct 2015, 08:00
End:
Wed, 7 Oct 2015, 04:00
Website:
Venue:
Exhibit
Symposia
Workshops
Organiser
Sponsor
General Info
Top Five Reasons To Attend
1. Learn from the industry’s leading clinical operations and quality experts as they candidly share their experiences, strategies and guidance for selecting and managing your clinical partners to ensure compliance and maximum performance.
2. Benchmark your clinical quality oversight strategy against other similar-sized companies to ensure your approach is optimal and effective.
3. Integrate risk-based approaches for effectively selecting, monitoring and managing your clinical vendors and sites — while optimizing your resources.
4. Position your trial for success by ensuring your clinical vendors and sites are inspection ready with the latest tools, technologies and audit strategies.
5. Design your own agenda and choose your preferred learning environment with the selection of interactive workshops, session tracks, educational presentations, dynamic panels, interactive roundtables and ample networking opportunities
Who Should Attend
Professionals from pharma, biotech and medical device companies; CROs; and other clinical trial service providers whose responsibilities involve the following:
· Quality Management/Clinical Quality Management o Clinical Quality Assurance/QA/CQA o Clinical Quality Control/QC/CQC · Clinical Operations/Management/Research/Development · Compliance/Clinical Compliance/Regulatory Compliance · Monitoring/Site Management/Study Management | · Clinical Outsourcing/Vendor Management/Third Party Management · Good Clinical Practice/GCP · Auditing · Clinical Risk/Risk Assessment · Regulatory Affairs · Medical Affairs |
This event is also of interest to: | |
· Investigative Sites · Academic Research Organizations · Central, Imaging and ECG Labs | · IVRS Companies · EDC Companies · Other Clinical Service Providers |
Pricing and Registration
Pricing information for 6th Clinical Quality Oversight Forum | |
Early Bird Pricing — Register by August 21, 2015 Price | |
Conference and Full-Day Seminar | $2,395 |
Conference and Two Workshops | $2,395 |
Conference and One Workshop | $2,095 |
Conference Only | $1,795 |
Standard Pricing | Price |
Conference and Full-Day Seminar | $2,595 |
Conference and Two Workshops | $2,595 |
Conference and One Workshop | $2,295 |
Conference Only | $1,995 |
Onsite Pricing | Price |
Conference and Full-Day Seminar | $2,695 |
Conference and Two Workshops | $2,695 |
Conference and One Workshop | $2,395 |
Conference Only | $2,095 |
*Includes Sales Tax and Service Fees
Pre-Conference Day | ||
Monday, October 5 – Pre-Conference Day | ||
7:45AM – 8:30AM | Registration and Continental Breakfast | |
FULL-DAY INTERACTIVE SEMINAR | ||
| MHRA
INSPECTIONS Effectively Preparing for Tough MHRA Inspections — Managing Expectations, Prepping Sites and Vendors, and Reviewing Lessons Learned from Recent Inspections Paul
Strickland, Managing
Director, STRICKLAND QUALITY
ASSURANCE | |
WORKSHOP A | ||
8:30AM – 12:00PM | QMS
AT SMALL TO MID-SIZE COMPANIES Developing and Implementing an Effective Quality Management System with Limited Resources to Ensure Optimal Oversight and Management Sharon
Reinhard, President, CLINICAL COMPLIANCE SOLUTIONS, LLC | |
12:00PM
– 1:00PM | Lunch for Seminar and Workshop A Participants | |
12:30PM – 1:00PM | Registration for Workshop B Participants | |
FULL-DAY INTERACTIVE SEMINAR CONTINUED | ||
1:00PM – 4:30PM | MHRA
INSPECTIONS Effectively Preparing for Tough MHRA Inspections — Managing Expectations, Prepping Sites and Vendors, and Reviewing Lessons Learned from Recent Inspections Paul
Strickland, Managing
Director, STRICKLAND QUALITY
ASSURANCE | |
WORKSHOP B | ||
1:00PM – 4:30PM | TRIAL
MASTER FILE Utilizing the TMF as a Tool to Oversee and Manage the Quality of Clinical Vendors and Sites Donna
Dorozinsky, President, JUST IN TIME GCP | |
4:30PM – 4:30PM | Day Concludes | |
Main Conference Day 1 | ||
Tuesday, October 6 | ||
7:30AM – 8:15AM | Registration and Continental Breakfast | |
8:15AM – 8:30AM | CHAIRPERSON’S
WELCOME AND INDUSTRY UPDATE Kathy Goin, Vice President, Clinical Operations, TREVENA, INC. | |
8:30AM – 9:30AM | PFIZER
CASE STUDY: CLINICAL QUALITY METRICS Developing a Concise Set of High-Value Quality Metrics to Create an Organizational Framework for Effectively and Efficiently Managing Clinical Quality Jonathan Rowe, Ph.D.,
M.S., M.A., Head, Quality Performance Management, PFIZER | |
9:30AM – 10:15PM | EVOLVING
RISK INDICATORS Identifying Relevant Risk Indicators for Each Stage of the Trial to Optimize Quality Oversight by Mitigating Risk Early and Cost Effectively Duncan Hall, Chief Executive Officer, TRIUMPH RESEARCH INTELLIGENCE | |
10:15AM – 10:45AM | Networking and Refreshment Break | |
10:45AM – 11:45AM | PANEL
DISCUSSION: SELECTION AND QUALIFICATION Best Practices for Selecting and Qualifying Clinical Vendors and Sites to Mitigate Risk Moderator: | |
11:45AM – 12:30PM | VERTEX CASE STUDY:
DATA-DRIVEN COMPLIANCE Conducting Data Analysis to Proactively Identify Issues and Leverage Existing Technologies, Processes and Relationships to Implement an Effective Data Quality Oversight Strategy Deidra Poucher, RN, MSHS, RQAP-GCP, Associate Director, GCP Auditing, VERTEX PHARMACEUTICALS INC. | |
12:30PM – 1:30PM | ||
1:30PM – 2:30PM | PANEL
DISCUSSION: GCP QUALITY MANAGEMENT SYSTEMS Practical Strategies for Optimizing Clinical Oversight Through the Use of Quality Management Systems Moderator: | |
2:30PM – 3:15PM | OPTIMIZE
DATA QUALITY François Torche, CEO, CLUEPOINTS | |
3:15PM – 3:45PM | Networking and Refreshment Break | |
3:45PM – 4:45PM | PANEL DISCUSSION: EVOLVING MONITORING METHODOLOGIES Comparing Experiences with Risk-Based, Centralized and Remote Monitoring Methodologies and Sharing Practical Tips for Effective Execution Moderator: | |
4:45PM – 5:30PM | ROUNDTABLE DISCUSSIONS Each conference participant selects one topic from the following list to discuss in an intimate setting. 1. QUALITY BY DESIGN: Recognizing the Trial Protocol as a Critical Quality Management Tool 2. EDUCATION AND TRAINING: Examining the Evolving Training and Education Needs and Developing an Effective Risk-Based Strategy 3. QUALITY AGREEMENTS: Discussing the Purpose and Critical Components of an Effective Quality Agreement 4. QUALITY INDICATORS: Identifying and Utilizing Key Quality Indicators to Mitigate Risk and Assess the Ongoing Performance of Clinical Vendors and Sites 5. RISK-BASED AUDITING: Best Practices for Developing Effective Risk-Based Clinical Auditing Plans and Approaches 6. OPTIMIZING RESOURCES AT SMALL COMPANIES: Discussing Resource Issues and Operational Concerns Unique to Smaller Companies 7. GLOBAL OVERSIGHT CHALLENGES: Identifying and Overcoming Common Challenges When Overseeing Vendors and Sites on a Global Level 8. VENDOR CONTRACTS: Developing a Contract that Incorporates Quality Requirements and Oversight Expectations to Ensure Data Integrity 9. OVERSEEING TECHNICAL SERVICE PROVIDERS: Proven Strategies for Effectively Overseeing Quality at Labs, ePROs, EDC and Other Technical/Specialist Service Providers 10. THIRD-PARTY OVERSIGHT: How Do You Effectively Outsource Oversight Responsibilities and What Does That Entail? | |
5:30PM – 6:15PM | Networking Reception | |
Main Conference Day 2 | ||
Wednesday, October 7 | ||
7:30AM – 8:00AM | Registration and Continental Breakfast | |
8:00AM – 8:15AM | CHAIRPERSON’S OPENING AND RECAP OF PREVIOUS DAY Kathy Goin, Vice President, Clinical Operations, TREVENA, INC. | |
8:15AM – 9:00AM | CLINICAL CAPAs Effectively Responding to Noncompliance with Proper Development and Execution of Corrective and Preventive Actions (CAPAs) Kevin J. Wilson, Manager - Quality Systems, Medicines Quality Organization, ELI LILLY & CO. | |
9:00AM – 9:45AM | QUALITY OVERSIGHT OF LATE PHASE RESEARCH Developing a Robust Yet Pragmatic Quality Oversight and Compliance Strategy for Registries and Late Phase Studies Christine Sahagian, Head of Registries and Late Phase QA and Compliance, SHIRE | |
9:45AM – 10:30AM | PANEL DISCUSSION: ACHIEVING INSPECTION READINESS Proven Strategies and Best Practices for Ensuring Vendors and Sites Are Inspection Ready Moderator: Steven Talerico, Associate Director, SRPM, GLOBAL INSPECTIONS LEAD, GLOBAL CLINICAL TRIAL OPERATIONS, MERCK Panelists:Kathy Goldstein, PharmD, RPh, CCRA, Director, Clinical Quality Operations, ALEXION PHARMACEUTICALS, INC. Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Linda Sullivan, Co-Founder and President, METRICS CHAMPION CONSORTIUM (MCC) | |
10:30AM – 11:00AM | Networking and Refreshment Break | |
TRACK A | ||
11:00AM – 11:45AM | INDUSTRY SURVEY RESULTS: SMALL TO MID-SIZED COMPANIES Evaluating the Small/Mid Sponsor Landscape and Benchmarking Your Outsourcing Strategy, QMS Development and Oversight Challenges Against Similarly Sized Companies Linda Sullivan, Co-Founder and President, METRICS CHAMPION CONSORTIUM (MCC) | |
11:45AM – 12:30PM | RISK-BASED AUDITING Developing a Comprehensive Risk-Based Auditing Approach as an Effective Oversight Tool Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC | |
TRACK B | ||
11:00AM – 11:45AM | MERCK CASE STUDY: VENDOR COMMUNICATION PLAN Establishing a Clear Communication Plan with Clinical Vendors to Ensure Transparency and Compliance Ray LaVera, Associate Director, Clinical Quality and Process Management, MERCK | |
11:45AM – 12:30PM | REGENERON CASE STUDY: ESCALATION PLANS Proactively Developing an Effective Escalation Plan to Streamline Execution and Issue Resolution Kristy Nease, Director, Clinical Compliance and Training, REGENERON PHARMACEUTICALS, INC. | |
12:30PM – 1:30PM | Lunch | |
1:30PM – 2:15PM | DOCUMENTING VENDOR OVERSIGHT Effectively Documenting the Oversight Process to Ensure Inspection Readiness Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES, INC. | |
2:15PM – 3:00PM | PANEL DISCUSSION: INTEGRATING QUALITY AND OPERATIONS Establishing Effective Communication Channels and Synchronizing Processes Between Clinical Quality and Operations to Streamline Quality Oversight Moderator: Janice Hutt, Chief Operating Officer, THE AVOCA GROUP Panelists: Ray LaVera, Associate Director, Clinical Quality and Process Management, MERCK Darrell Morrow, Senior Director, Quality Systems, ACCELERON PHARMA Christine Sahagian, Head of Registries and Late Phase QA and Compliance, SHIRE | |
3:00PM – 3:00PM | Close of Conference | |
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