October 5-7, 2015 | Sonesta Philadelphia | Philadelphia...

To Register Call 866-207-6528 or Visit www.exlevents.com/qualityoversight

CLINICAL QUALITY OVERSIGHT FORUM

6th AnnualOctober 5-7, 2015 | Sonesta Philadelphia | Philadelphia, PA

PFIZER CASE STUDY: CLINICAL QUALITY METRICSDeveloping a Concise Set of High-Value Quality Metrics to Create an Organizational Framework for Effectively and Efficiently Managing Clinical Quality

FEATURED SESSIONS

Sponsors and Exhibitors

Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites

Kathy Goin Vice President, Clinical Operations TREVENA, INC.

Jonathan Rowe, Ph.D., M.S., M.A., Head, Quality Performance Management, PFIZER

Denise Calaprice-Whitty, Ph.D., Senior Consultant,

THE AVOCA GROUP

CONFERENCE CHAIR

EXPERT PANEL DISCUSSIONS❖ Selection and Qualification Strategies ❖ GCP Quality Management Systems❖ Evolving Monitoring Methodologies❖ Achieving Inspection Readiness ❖ Integrating Quality and Operations

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

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.

RISK-BASED AUDITING Developing a Comprehensive Risk-Based Auditing Approach as an Effective Oversight Tool Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Senior GCP Auditor Consultant, UNITED THERAPEUTICS

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.

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.

PRE-CONFERENCE DAY

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

MORNING WORKSHOP QMS AT SMALL TO MID-SIZE COMPANIES Developing and Implementing an Effective Quality Management System with Limited Resources to Ensure Optimal Oversight and Management

AFTERNOON WORKSHOP TRIAL MASTER FILE Utilizing the TMF as a Tool to Oversee and Manage the Quality of Clinical Vendors and Sites

www.exlevents.com/qualityoversight

To Register Call 866-207-6528 or Visit www.exlevents.com/qualityoversight2|

Dear Colleague,

An effective oversight strategy is critical to the success of your clinical trial. With outsourcing at an all-time high and continuing to rise, risk-based approaches for quality management being implemented, and new quality management systems and processes for tracking quality data being adopted, the complexities are many and the challenges great to effectively assessing, optimizing and managing the quality of your clinical partners. Now in it’s 6th year, ExL’s Clinical Quality Oversight Forum provides a unique interactive forum for clinical professionals to candidly share, discuss and develop ideas and strategies for identifying and mitigating risk when working with clinical vendors and sites.

I look forward to seeing you in October! Please don’t hesitate to contact me if you have any questions.

Sincerely,

Kristen Hunter

Kristen HunterEvent [email protected] 212-400-6241

WHO SHOULD ATTEND?

The event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:

❖ Quality Management/Clinical Quality - Clinical Quality Assurance/QA/CQA - 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/Auditor ❖ Clinical Risk/Risk Assessment ❖ Regulatory Affairs ❖ Medical Affairs

The event is also of interest to:❖ Investigative Sites ❖ Academic Research Organizations ❖ Central, Imaging and ECG Labs ❖ IVRS Companies ❖ EDC Companies ❖ Other Clinical Service Providers

VENUESonesta Philadelphia 1800 Market Street Philadelphia, PA 19103

The new Sonesta Philadelphia Downtown 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.

To make reservations please call 1-800-SONESTA (766-3782) and request the negotiated rate for ExL’s October Meetings. You may also make reservations online using the following weblink: http://bit.ly/1EC18vv

The group rate is available until September 14, 2015. Please book your room early as rooms available at this rate are limited.

DO YOU WANT TO REACH THE AUDIENCE AT THIS EVENT? If this audience represents your potential clients, then take advantage of the opportunity to exhibit, present an educational session, share your expertise on a panel discussion, host a networking event and/or distribute promotional materials at this conference. ExL works closely with you to customize a package that suits all of your needs.

To learn more about these opportunities, please contact Andrew Sinetar, Event Sales Director, at 212–400–6237 or [email protected].

70% Pharmaceutical, Biotech and

Medical Device Companies

12% CROs

12% Other Clinical Service

Providers

6% Other

50% Clinical Quality/Compliance

30% Clinical Operations/Management

10% Outsourcing/Vendor Management

5% Audits/Inspections

5% Other

2014 AUDIENCE PROFILE

Company Type

Department

50%

30%

10%

5%5%

70%

12%

12%

6%


6th Annual

mailto:[email protected]


To Register Call 866-207-6528 or Visit www.exlevents.com/qualityoversight |3

MONDAY, OCTOBER 5, 2015 PRE-CONFERENCE DAY❖

7:45 Registration and Continental Breakfast

8:30 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 ❖ Reviewing what’s changed

- Evaluating the reasons MHRA inspections are quickly becoming the most “feared” type of inspection - Discussing the recent changes that have occurred and whether you

should be concerned ❖ Understanding the MHRA

- Who are the MHRA?- Evaluating the similarities and differences between the role of MHRA

and other regulatory agencies ❖ Examining the qualities of an MHRA inspection

- Identifying aspects unique to MHRA inspections - Pinpointing their areas of focus - Being aware of what to expect

❖ Knowing the Inspector - Interactive exercise: Access the mind of an inspector - Evaluating what you would you include on your own inspection and

using that to better prepare

10:00 30-Minute Networking Break

12:00 Lunch for Seminar Participants

1:00 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


Erika P. Zavod, Director, SOPs, Procedures and Training Global Clinical Operations, TEVA PHARMACEUTICALS GLOBAL R&D ❖ Preparing for an inspection

- Developing the pre-inspection dossier - Establishing the critical components

- Defining what actions need to be taken to adequately prepare for the inspection

- Discussing serious breach and urgent safety measure legislation ❖ Facilitating an inspection

- Learning how to get the optimum result from the inspection- Analyzing techniques that have helped in the past- Understanding and defining the roles of the facilitation team

❖ Reviewing common findings- Focusing your preparation on the areas where the MHRA makes the

most findings — information from the agency itself ❖ Responding to findings

- Crafting a response — your response can make a dramatic difference to the impact of a finding- A poor response can raise your risk rating- A thorough response gives the inspectors confidence that you will

resolve the issue- Examining tips for responding in an appropriate manner


4:30 Seminar Concludes

MHRA INSPECTIONS

MHRA INSPECTIONS CONTINUED

FULL-DAY INTERACTIVE SEMINAR HALF-DAY WORKSHOPS


8:30 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.❖ Understanding the key elements of a Quality Management

System (QMS)- Examining strategic and tactical activities- Learning how to implement these activities in clinical operations,

data management, statistics and pharmacovigilance areas ❖ Mapping out the components of a clinical QMS

- Deciding which SOPs and documentation you should have in place across GCP/GPvP

- Clarifying what metrics, methods or trend analysis you can perform to assess quality

- Demonstrating management awareness of quality issues and commitment to continuous improvement

- Delivering an inspection ready program❖ Applying the QMS in the Clinical/GCP environment❖ Determining how to resource the clinical QMS activities ❖ Exploring varying methods for documenting QMS activities❖ Demonstrating sponsor oversight❖ Leveraging the QMS to ensure you are inspection ready❖ Evaluating activities within your own company utilizing the information,

tools and templates provided to workshop participants


12:00 Workshop A Concludes and Lunch for Workshop A Participants

12:30 Registration for Workshop B Participants

1:00 Utilizing the TMF as a Tool to Oversee and Manage the Quality of Clinical Vendors and SitesDonna Dorozinsky, President, JUST IN TIME GCP

Susan Ridge, Director, Clinical Operations Administration (retired), SUNOVION ❖ Defining the TMF and the understanding the value

- Identifying how the TMF evolved over the last decade- Reviewing the function of a TMF and establishing why it is necessary - Recognizing the need for and benefit of having a complete TMF

❖ Modeling the structure for a complete TMF - Defining the critical components - Managing TMF content held in a multitude of locations - Mapping the information - Deciding who has access to the TMF- Assessing the purpose and effective use of Notes to File (NTF)

❖ Ensuring a complete TMF - Developing standards and checklists for all documents - Identifying missing information- Establishing initial and ongoing TMF review strategies - Defining the responsibilities of sponsor and CRO for ensuring the

TMF is complete ❖ Using a TMF as an oversight tool

- Conducting risk-based QC of the TMF to identify problem areas - Performing ongoing TMF reviews to ensure the quality and

completeness of trial data - Examining the TMF to find quality gaps in the study

❖ Achieving inspection readiness


4:30 Workshop B Concludes

WORKSHOP A: QMS AT SMALL TO MID-SIZE COMPANIES

WORKSHOP B: TRIAL MASTER FILE



“I’ve had the privilege of participating in and presenting at several ExL Pharma conferences in the US and Europe. This company arranges some of the best-organized and informative industry conferences in my experience. Topics are

relevant, presenters are engaged, and the mix of presentation/ panel/ discussion strikes the right balance for effective education. In addition, the people at ExL Pharma are truly professional in their development and execution of these important events.”

Anton Ehrhardt, PhD, Senior Director, Oncology Field Operations, SANOFI-AVENTIS


8:15 CHAIRPERSON’S WELCOME AND INDUSTRY UPDATE

Kathy Goin, Vice President, Clinical Operations, TREVENA, INC. ❖ Building a common language for quality

- Explaining the terms❖ Defining oversight and assessing why is it important ❖ Examining current industry trends, their drivers and the

impact on oversight strategies

8:30 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 ❖ Defining quality metrics and addressing how to

differentiate those from operational metrics❖ Understanding the importance of, and how to develop, a

framework for the organization of quality metrics❖ Evaluating the different categories of quality metrics and

the purposes of each, the expected relationships between metrics in these categories, and the level(s) at which each should be reviewed and actioned- Identifying which metrics are critical for the effective

quality oversight of clinical vendors and sites ❖ Learning to assemble information to promote a

comprehensive evaluation of quality management findings❖ Reviewing the latest results from Pfizer’s six-month full

implementation plan, along with key lessons learned

9:30 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❖ Recognizing the value in a set of risk indicators that

change as a clinical trial evolves❖ Identifying effective risk indicators at varying stages of trial

development and execution ❖ Utilizing different data sources for different risk indicators ❖ Understanding the audit implication of changing risk

indicators, and ensuring your platform can support that need

❖ Proactive risk analysis through a flexible risk indicator set as a cost-effective tool to identify risk earlier

10:15 Networking and Refreshment Break

10:45 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 and GPvP, ALKERMES, INC.

Jim Sheets, Senior Director, Clinical Quality Assurance, FIBROGEN, INC.

Cheri Wilczek, President, CLINAUDITS, LLC❖ Employing strategies for effective risk and capability

assessments when choosing a clinical vendor and/or site - Determining which critical financial, business and quality

factors to take into consideration - Defining effective quality assurance practices when

selecting and qualifying vendors and sites - Identifying assessment tools and processes that have

worked well - Instituting study-specific criteria and comparing it

to capabilities❖ Utilizing qualification audits as a risk assessment tool for

vendors and sites- Examples of types of audit observations that impact

selection and qualification

11:45 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.❖ Evaluating current data sources to assess risk and

determine possible quality issues ❖ Defining key components of an effective data quality

oversight plan ❖ Utilizing existing technologies to execute a data quality

oversight plan ❖ Leveraging vendor and site relationships to improve data

quality

12:30 Lunch

TUESDAY, OCTOBER 6, 2015 MAIN CONFERENCE❖

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TUESDAY, OCTOBER 6, 2015 MAIN CONFERENCE❖

1:30 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:

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. ❖ Defining what is a quality management system (QMS) is ❖ Examining the varying types of QMS ❖ Reviewing challenges and lessons learned when developing

and implementing a QMS ❖ Discussing practical examples of utilizing the QMS to

mitigate risk and monitor the performance of vendors and sites

2:30 OPTIMIZE DATA QUALITY

Combining Risk-Based Monitoring with an Effective Data Quality Oversight Strategy to Mitigate RiskFrançois Torche, CEO, CLUEPOINTS❖ Recognizing the reality of 0% SDV and 100% data quality

oversight ❖ Examining a unique statistical approach to interrogating

operational data resulting in an optimum set of Key Risk Indicators (KRIs)

❖ Coupling KRIs with central statistical monitoring to effectively de-risk late phase studies

❖ Identifying potentially critical data anomalies from examinations of over 50 studies

❖ Improving data quality and integrity by relying on both technology and process change


3:45 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, WILLIAM S. JOHNSON CONSULTING

Deidra Poucher, RN, MSHS, RQAP-GCP, Associate Director, GCP Auditing, VERTEX PHARMACEUTICALS INC.

Christine Siaton, MBA, Quality Assurance & Compliance Lead, SHIRE❖ Defining the varying monitoring approaches and

understanding the differences ❖ Assessing which monitoring approach makes sense based

on the criteria of the study and the available resources❖ Identifying common implementation and compliance

challenges on both the sponsor and the site level, and best practices for overcoming them

❖ Developing strategies for working better with sites when implementing new monitoring models

❖ Evaluating changing training and education needs ❖ Generating tips, tricks and best practices based on

panelists’ experiences

4:45 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 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?

5:30 Networking Reception

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TRACK A TRACK B11:00

Evaluating the Small/Mid Sponsor Landscape and Benchmarking Your Outsourcing Strategy, QMS Development and Oversight Challenges against Similarly Sized Companies

Linda Sullivan, Co-Founder & President, METRICS CHAMPION CONSORTIUM (MCC)❖ Sharing the MCC’s never before presented small to mid-sized

company survey results:- Comparing your company’s outsourcing strategy to others in the industry

- Evaluating how your vendor management and quality oversight practices compare to similarly sized companies

- Learning how smaller companies are using scorecards as an oversight tool

- Identifying the industry’s common oversight challenges when working with limited resources

Establishing a Clear Communication Plan with Clinical Vendors to Ensure Transparency and Compliance

Ray LaVera, Associate Director, Clinical Quality and Process Management, MERCK

❖ Recognizing the need for a communication plan ❖ Defining the critical elements of an effective communication

strategy/plan ❖ Developing communication road maps for varying scenarios to

manage expectations❖ Demonstrating how a communication plan relates to the

contract and quality agreements

INDUSTRY SURVEY RESULTS: SMALL TO MID-SIZED COMPANIES

MERCK CASE STUDY: VENDOR COMMUNICATION PLAN

First Time

Presented


WEDNESDAY, OCTOBER 7, 2015 MAIN CONFERENCE ❖


8:00 CHAIRPERSON’S OPENING AND RECAP OF PREVIOUS DAY

Kathy Goin, Vice President, Clinical Operations, TREVENA, INC.

8:15 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.❖ Establishing the criteria for when a CAPA is necessary Developing a CAPA system to effectively monitor and

track status ❖ Coordinating with the sponsor and the site when executing

a CAPA- Assessing who should be involved and when- Determining how transparent the process should be to

ensure effectiveness ❖ Effectively monitoring the CAPA to ensure it’s completed in

a timely manner

9:00 QUALITY OVERSIGHT OF LATE PHASE RESEARCH

Developing a Robust Yet Pragmatic Quality Oversight and Compliance Strategy for Registries and Late Phase StudiesChristine Sahagian, Head of Registries and Late Phase QA and Compliance, SHIRE❖ Understanding applicable regulations and standards❖ Aligning the organization on nomenclature❖ Working with stakeholders to develop appropriate and

effective procedures for late phase programs

❖ Establishing a risk-based auditing approach to oversee registries and late phase research

9:45 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, Senior GCP Auditor Consultant, UNITED THERAPEUTICS

Linda Sullivan, Co-Founder & President, METRICS CHAMPION CONSORTIUM (MCC)❖ Reviewing the panel’s recent vendor and site inspection

experiences ❖ Comparing and contrasting inspections by different

regulatory authorities - Identifying which agency is most feared and why - Analyzing how inspections are changing

❖ Outlining best practices for managing expectations and preparation strategies

❖ Defining the role of the sponsor and the CRO during a site inspection

❖ Sharing lessons learned and/or advice on inspection readiness, gained from inspection experience

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TRACK A TRACK B11:45

Developing a Comprehensive Risk-Based Auditing Approach as an Effective Oversight Tool

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Senior GCP Auditor Consultant, UNITED THERAPEUTICS ❖ Recognizing the differences between risk-based auditing and

risk-based monitoring ❖ Identifying the critical components of an effective risk-based

auditing plan ❖ Establishing risk thresholds and parameters to focus

auditing efforts ❖ Allocating resources to conduct, execute and manage the audits ❖ Interpreting the audit yields and benefits to adjust auditing

efforts

Proactively Developing an Effective Escalation Plan to Streamline Execution and Issue Resolution

Kristy Nease, Director, Clinical Compliance & Training, REGENERON PHARMACEUTICALS, INC. ❖ Having a plan and/or defined processes in place at the start of

the trial to handle any identified noncompliance or errors ❖ Working with partners at the onset to collectively define and

agree upon - Triggers for investigation- Processes for distributing information - Key roles and responsibilities

❖ Identifying the appropriate levels of transparency when a noncompliance is found

❖ Walking through the critical elements of an effective escalation plan

❖ Utilizing the escalation plan to avoid playing the blame game and focus efforts on finding a solution

12:30 Lunch

“This seminar was one of the best I have attended.” Joan Millsaps, Director, Business Operations and Outsourcing Management,

BRISTOL-MYERS SQUIBB CORPORATION

RISK-BASED AUDITING REGENERON CASE STUDY: ESCALATION PLANS

1:30 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.❖ Knowing what processes and actions should be

documented to demonstrate that effective oversight is being conducted

❖ Explaining how oversight processes and actions should be recorded - Answering the following questions:

- What are the inspectors looking for? - What is important? - What is not enough? - Is there such a thing as over documentation?

❖ Integrating the appropriate documentation actions into your oversight processes from the start of the trial so you are always inspection ready

2:15 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❖ Defining the roles and responsibilities of clinical quality and

operations teams to avoid redundant and conflicting efforts ❖ Developing a communication plan for addressing issues

and concerns ❖ Making effective process/communication plans for

interacting with vendors - Deciding who should be engaged with the vendor and

when ❖ Addressing the impact of disconnect between these

functions on quality oversight ❖ Delving into best practices for streamlining communication

and operations to ensure compliance

3:00 Close of Conference

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Registration Fees for Attending ExL’s 6th Clinical Quality Oversight Forum:

Early Bird Pricing - Register by Friday, August 21, 2015Conference and Full-Day Seminar. . . . $2,395 Conference and Two Workshops. . . . . $2,395 Conference and One Workshop . . . . . $2,095Conference Only. . . . . . . . . . . . . . . . $1,795

Standard Pricing - Register After August 21, 2015Conference and Full-Day Seminar. . . . $2,595 Conference and Two Workshops. . . . . $2,595 Conference and One Workshop . . . . . $2,295Conference Only. . . . . . . . . . . . . . . . $1,995

Onsite Pricing Conference and Full-Day Seminar. . . . $2,695 Conference and Two Workshops. . . . . $2,695 Conference and One Workshop . . . . . $2,395Conference Only. . . . . . . . . . . . . . . . $2,095

Inquire about Full-Time Academic and Government Rates – call 866-207-6528.

GROUP DISCOUNT PROGRAMSave 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 four at one time). This is a savings of 25% per person.

Save 15% Per Person When Registering ThreeCan only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call 866-207-6528.

IMPORTANT: Discount offers may not be combined. Discounts only apply to standard rate, early bird rate DOES NOT apply.Make checks payable to ExL Events, Inc. and write code C591 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full prior to the commencement of the conference.

TERMS & 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.

PAYMENT: Must be received in full by the conference date. All discounts will be applied to the Conference Only fee (excluding add-ons)‚ 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 discount pricing options.

CANCELLATION AND REFUND POLICY:If you need to cancel your registration for an upcomingExL event, please note the following policies derived from the Start Date of the event:• Four weeks or more: A full refund (minus a $295 processing fee) or a credit voucher to another ExL event valid for 12 months from the voucher issue date.• Less than four weeks: A credit voucher to another ExL event valid for 12 months from the voucher issue date.If you cancel at any time after receiving the conference documentation, the credit voucher issued will be $395 less.

CREDIT VOUCHERS: Credit Vouchers are valid for 12 months from date of issue. Credit Vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is no longer applicable now or in the future. Once a Credit Voucher has been applied toward a future event, changes cannot be made.

In the event of a cancellation on the attendees’ behalf, the Credit Voucher will no longer be valid.

SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference.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‚ speakers or venue.* The opinions of ExL speakers do not necessarily

reflect those of the companies they represent or ExL Events, Inc.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made.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 purposes of copyrighting or 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 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 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.

REGISTRATION INFORMATION❖

Fax: 888-221-6750Five Ways to Register:

Email: [email protected]

Online: www.exlevents.com/qualityoversight Phone: 866-207-6528 Mail: ExL Events, Inc.494 8th Ave, 4th FloorNew York, NY 10001

QUESTIONS? COMMENTS? • Do you have questions or comments about the agenda?

• Is there a specific topic missing that you would like to see addressed?

• Would you like to get involved as a speaker, panelist or roundtable moderator?

Please contact Event Director Kristen Hunter at 212-400-6241 or [email protected]. She’d be happy to discuss any of the above with you, or address any other questions you have about this program.

MEDIA PARTNERS:

Outsourcing -Pharma.com

36OPMTHE FULL SPECTRUM OF PRODUCT MANAGEMENT

36O

“ My compliments to the entire ExL Pharma team for how you operate. You have a well-oiled operation. Everyone has a positive “can do” attitude. The entire experience was extremely positive and I can’t thank you enough!”

Janis L. Hall, MBA, COP, Former Director, Global Pharma R&D Sourcing, Cardiovascular and Metabolism, JANSSEN RESEARCH & DEVELOPMENT, LLC

“ Conference was a positive open forum that provided an opportunity for sponsors and vendors to come together and share experiences and lessons learned, and identify a path to improve sponsor oversight through better channels of communication.”

Maryann Livolsi, Associate Director, Global R&D Quality Assurance, SHIRE PHARMACEUTICALS

“ The conference and speakers were all excellent. This was a very valuable conference and input from the participants will improve our quality oversight of vendors.”

Brandy Schenck, Auditor, Quality Assurance, INFINITY PHARMACEUTICALS

“ This was one of the best I’ve attended in a long while. Interactions were excellent.”

Grace Crawford, Senior Director, QA, ICON

TESTIMONIALS

MORE INFORMATION❖

ASSOCIATION PARTNERS:





ExL Events, Inc.Mail: 494 8th Avenue, 4th Floor New York, NY 10001

Phone: 866-207-6528

Online: www.exlevents.com/qualityoversight

Email: [email protected]

Fax: 888-221-6750

Five Ways to Register:Method of Payment: q Check q Credit Card

Make checks payable to: ExL Events, Inc.

Card Type: q MasterCard q Visa q Discover 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 email updates on ExL Pharma’s upcoming events

CONFERENCE CODE: C591q Yes! Register me for the Conference and Full-Day Seminar (MHRA Inspections)

q Yes! Register me for the Conference and Two Workshops

q Yes! Register me for the Conference and Workshop A (QMS at Small/Mid Cos)

q Yes! Register me for the Conference and Workshop B (Trial Master File)

q Yes! Register me for the Conference Only

Name:___________________________________ Title:__________________

Company:_______________________________________________________

Dept.:___________________________________________________________

Address:_________________________________________________________

City:_______________________________________ State:______ Zip:______

Email:___________________________________________________________

Phone:_____________________________ Fax:__________________________

To Register Call 866-207-6528 or Visit www.exlevents.com/qualityoversight


6th Annual October 5-7, 2015 | Sonesta Philadelphia | Philadelphia, PA

Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites

Jonathan Rowe, Ph.D., M.S., M.A., Head, Quality Performance Management, PFIZER

Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES, INC.

Paula Brust, Director, Quality Assurance (GCP), VITAL THERAPIES, INC.

Kevin J. Wilson, Manager - Quality Systems, Medicines Quality Organization, ELI LILLY & CO.

Christine Sahagian, Head of Registries and Late Phase QA and Compliance, SHIRE


Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Senior GCP Auditor Consultant, UNITED THERAPEUTICS

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

Kathy Goin Vice President, Clinical Operations TREVENA, INC.

EXTENDED INTERACTIVE SESSIONS❖ FULL-DAY SEMINAR: MHRA Inspections ❖ HALF-DAY WORKSHOP: QMS At Small To

Mid-Size Companies ❖ HALF-DAY WORKSHOP: Trial Master File

EXPERT PANEL DISCUSSIONS❖ Selection and Qualification Strategies ❖ GCP Quality Management Systems ❖ Evolving Monitoring Methodologies❖ Achieving Inspection Readiness ❖ Integrating Quality and Operations

Sponsors and Exhibitors

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NFE

REN

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Deidra Poucher, RN, MSHS, RQAP-GCP, Associate Director, GCP Auditing, VERTEX PHARMACEUTICALS INC.




October 5-7, 2015 | Sonesta Philadelphia | Philadelphia...

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