6th Annual Clinical Quality Oversight Forum

Start

Mon, 5 Oct 2015, 08:00

End

Wed, 7 Oct 2015, 04:00

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Venue:

ExL’s 6th Clinical Quality Oversight Forum, taking place October 5-7 at the Sonesta Hotel in Philadelphia, focuses on ensuring trial integrity by effectively assessing, optimizing and managing the quality of clinical vendors and sites. This forum acts as the annual gathering for clinical quality, operations, management and audit professionals to engage and candidly share their experiences, struggles, obstacles and achievements when working with varying clinical partners, including CROs and investigator sites. Learn from this experienced group and take away proven, results-driven, risk-based strategies for optimizing your company’s clinical vendor and site oversight approach.

Exhibit

Symposia

Workshops

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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

Click to register here.

Pre-Conference Day
Monday, October 5 – Pre-Conference Day

7:45AM – 8:30AM	Registration and Continental Breakfast

FULL-DAY INTERACTIVE SEMINAR

8:30AM – 12:00PM	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 former Director, Inspections and Intelligence, Global R&D Compliance, AMGEN UK Stacey L. Basham, RQAP-GCP, Assistant Director, R&D GCP Quality Assurance, ABBVIE Erika P. Zavod, Director, SOPs, Procedures and Training Global Clinical Operations, TEVA PHARMACEUTICALS GLOBAL R&D

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 Katie D. Alberta, BSN, Global Head, CQA; GCP and GPvP,ALKERMES, INC.

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 former Director, Inspections and Intelligence, Global R&D Compliance, AMGEN UK Stacey L. Basham, RQAP-GCP, Assistant Director, R&D GCP Quality Assurance, ABBVIE Erika P. Zavod, Director, SOPs, Procedures and Training Global Clinical Operations, TEVA PHARMACEUTICALS GLOBAL R&D

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 Susan Ridge, Director, Clinical Operations Administration (retired), SUNOVION

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* *Denise Calaprice-Whitty, Ph.D., Senior Consultant, THE AVOCA GROUP*

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: *Sharon Reinhard, President, CLINICAL COMPLIANCE SOLUTIONS, LLC* Panelists: *Katie D. Alberta, BSN, Global Head, CQA; GCP & GPvP, ALKERMES, INC.* *Jim Sheets, Senior Director, Clinical Quality Assurance, FIBROGEN, INC.* *Cheri Wilczek, President, CLINAUDITS, LLC*

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		Lunch
1:30PM – 2:30PM		PANEL DISCUSSION: GCP QUALITY MANAGEMENT SYSTEMS Practical Strategies for Optimizing Clinical Oversight Through the Use of Quality Management Systems Moderator: *Terry Robinson, Senior Director, Pharmaceutical Practice, APPIAN CORPORATION* Panelists: *Stacey L. Basham, RQAP-GCP, Assistant Director, R&D GCP Quality Assurance, ABBVIE* *Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES, INC.* *Kevin J. Wilson, Manager - Quality Systems, Medicines Quality Organization, ELI LILLY & CO.*

2:30PM – 3:15PM		OPTIMIZE DATA QUALITY Combining Risk-Based Monitoring with an Effective Data Quality Oversight Strategy to Mitigate Risk *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: *Michael J. Howley, Ph.D., Associate Clinical Professor, Business, LEBOW COLLEGE OF BUSINESS, DREXEL UNIVERSITY* Panelists: *Bill Johnson, President, WILLIAM S. JOHNSON CONSULTING* *Deidra Poucher, RN, MSHS, RQAP-GCP, Associate Director, GCP Auditing, VERTEX PHARMACEUTICALS INC.* *Maryann Livolsi, MSN, RN, RQAP, GCP, Head of Clinical QA and Compliance Programs, R&D Quality Assurance and Compliance, SHIRE*

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