Proactive GCP Compliance9th

Effective Risk-Based Approaches for Optimizing Clinical Quality and Achieving Inspection Readiness

March 19-21, 2018 | Sheraton Philadelphia University City Hotel | Philadelphia, PA

Joanne Spallone, Global Development Quality Audit Head, NOVARTIS

CONFERENCE CHAIR

INTERACTIVE HALF-DAY WORKSHOPS

FEATURED SESSIONS

LinkedIn Proactive GCP Compliance

ENSURING DATA INTEGRITY Examining Effective Strategies for Ensuring Data Integrity When Executing Risk-Based Management Approaches Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN

Besty Fallen, Regulatory and Clinical Process Consultant, BAFALLEN CONSULTING, LLC

INTERPRETING AND RESPONDING TO ICH E6 R2Understanding the Critical Elements of ICH E6 R2 and the Impact on Clinical Quality and Operations Peggy J. Berry, MBA, RAC, President and CEO, SYNERGY CONSULTING CONSULTING, LLC

SENIOR LEADERS PANEL: PROACTIVE RISK MANAGEMENT Understanding How Senior Leaders Are Developing a Culture of Quality to Drive a Proactive Risk Management Approach Panelists

PFIZER CASE STUDY: RISK MANAGEMENT MODERNIZATION Examining the Evolution of Risk Management Post-ICH E6 R2 and Outlining the Critical Changes That Have Occurred Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

TRIAL MASTER FILE Developing and Maintaining an Inspection-Ready Trial Master File (TMF) Bryan Souder, Director, TMF Head, MERCK

ACADIA CASE STUDY: SHIFTING TO PROACTIVE RISK MANAGEMENT Examining a Small Company’s Transition From Reactive Issue Resolution to ICH E6 R2 Compliant Proactive Risk Management and a Continual State of Inspection Readiness

Maryann Livolsi, MSN, RN, RQAP-GCP, Senior Director, R&D Quality Assurance, ACADIA PHARMACEUTICALSStefan van den Akker, M.Sc., Director, R&D Quality and Risk Management, ACADIA PHARMACEUTICALS

TESARO CASE STUDY: STANDARDIZING GxP SOPs Establishing a Foundation of Base Processes and Action Sequences That Are Consistent Across the Organization for Identification and Mitigation of Risk

Dan Greenwood, Senior Director, Quality Assurance, TESAROTwitter #GCPConference

Sponsors

Katie Alberta, Global Head, QA; GLP, GCP,

GPvP and PDMA,ALKERMES

Fred Feldstein, Vice President, Global Head of BioResearch Quality and

Compliance, JOHNSON & JOHNSON

Simon Trowell, Vice President, Quality and

Risk Management, R&D Projects, Clinical Platforms

and Sciences, GSK

SMALL COMPANY CASE STUDIES

Dear Colleague, Now in its ninth year, ExL’s Proactive GCP Compliance conference continues to act as the annual forum for senior-level clinical quality, compliance, and clinical operations executives to gather, learn, and discuss strategies to achieve and maintain global GCP compliance. Join us to learn how to effectively build quality risk management approaches into your clinical operations to optimize research, maintain GCP compliance, contain costs, and ensure patient safety.

55% Clinical Quality/Compliance

10% Other

10% Audits/Inspections

25% Clinical Operations/Management

Who Should Attend?This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinicl trial service providers whose responsibilities involve the following:

Good Clinical Practice/GCP

Clinical Quality Assurance/CQA

Clinical Quality Control/CQC

Compliance/Global Compliance

Quality Management/Global Quality Management

Clinical Operations/Development/Affairs/Management

Quality Systems

Vendor Oversight

Clinical Monitoring

Clinical Data

Regulatory Affairs

Safety and Risk Management/Operations Audit

.

2017 Audience Demographics

Company Type

Function

70% Pharma, Biotech, Device Companies

20% Other Clinical Service Providers

5% CROs

7:45 Registration and Continental Breakfast for Morning Workshop Participants

8:30 WORKSHOP A: INTERPRETING AND RESPONDING TO ICH E6 R2Understanding the Critical Elements of ICH E6 R2 and the Impact on Clinical Quality and Operations Peggy J. Berry, MBA, RAC, President and CEO, SYNERGY CONSULTING

› Identifying the aspects of ICH E6 and the addendum that impacts GCP » Defining the portions that relate to GCP » Understanding the elements that have changed as a result of the addendum » Evaluating regional variations and different possible interpretations

› Examining current operations to assess where changes must be made to remain compliant » Determining what does not need to change » Conducting a gap analysis of processes

› Developing an action plan to remain compliant » Assessing and assigning risk levels to prioritize resource allocation based on criticality » Constructing a methodological approach to achieve full compliance

› Executing the necessary changes » Evaluating who should be responsible for implementation and adherence » Examining possible barriers to implementation and how to overcome them » Creating metrics to visualize and oversee operations and ensure continual compliance

10:00 30-Minute Networking Break

12:00 Lunch for Morning Workshop Participants

12:30 Registration for Afternoon Workshop

1:00 WORKSHOP B: ENSURING DATA INTEGRITYExamining Effective Strategies for Ensuring Data Integrity When Executing Risk-Based Management Approaches Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGENBesty Fallen, Regulatory and Clinical Process Consultant, BAFALLEN CONSULTING, LLC

› Comparing data integrity and data quality and understanding how they impact one another › Evaluating current data sources to assess risk and determine possible quality issues  › Developing a data oversight plan to proactively identify issues  › Discussing best practices for conducting ongoing data analysis to assess the health of the data and the study   › Sharing technology and process changes that have resulted in improved data integrity and data quality  › Understanding the roles of vendors and sites in optimizing data integrity and data quality  › Leveraging the Trial Master File (TMF) to ensure data integrity

2:30 30-Minute Networking Break

4:30 Workshop Concludes

Hotel Information Sheraton Philadelphia University City Hotel

3549 Chestnut Street | Philadelphia, PA 19104

To make reservations, guests can call 1-888-627-7071 and request the group rate for ExL’s 9th Proactive GCP Compliance Conference. You may also make reservations online using the following weblink: https://goo.gl/KSPVAD. The group rate is available until February 26, 2018. Please book your room early, as rooms available at this rate are limited.*ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.

Monday, March 19, 2018 | Workshops

8:00 Registration and Continental Breakfast

8:45 CHAIRPERSON’S WELCOME AND INDUSTRY UPDATE Joanne Spallone, Global Development Quality Audit Head, NOVARTIS

9:15 SENIOR LEADERS PANEL: PROACTIVE RISK MANAGEMENT

Understanding How Senior Leaders Are Developing a Culture of Quality to Drive a Proactive Risk Management Approach PanelistsKatie Alberta, Global Head, QA; GLP, GCP, GPvP and PDMA, ALKERMESFred Feldstein, Vice President, Global Head of BioResearch Quality and Compliance, JOHNSON & JOHNSON Simon Trowell, Vice President, Quality and Risk Management, R&D Projects, Clinical Platforms and Sciences, GSK • Defining quality culture and what it means at your

company • Articulating the importance of a quality culture to gain

internal buy-in • Leveraging the quality culture to drive a continual

inspection-ready state • Evaluating effective proactive risk management

strategies

10:15 Networking Break

10:45 PFIZER CASE STUDY: RISK MANAGEMENT MODERNIZATION

Examining the Evolution of Risk Management Post-ICH E6 R2 and Outlining the Critical Changes That Have Occurred Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER • Discussing the drivers behind risk management before

R2 and how risks were identified, examined and mitigated

• Outlining the critical factors of ICH E6 R2 that changed the risk management approach

• Examining how risk management was modernized in response to ICH E6 R2

• Leveraging risk management to predict GCP risk and the impact on monitoring and auditing planning

• Describing an approach for identifying important questions to ask about a protocol that can identify risk

11:30 BUILDING A CULTURE OF COMPLIANCE Establishing an Effective Culture of Compliance to

Drive Clinical Quality Optimization Catherine Arthey, President, DARCY CONSULTING • Defining a culture of compliance and understanding the

purpose and benefits • Assessing your current state as a baseline to know where

and how to start • Developing an implementation plan and prioritizing the

steps • Knowing when you have completed the cultural change

and achieved the end goal • Examining real examples of process improvements that

resulted from this culture change

12:15 Lunch

1:15 TRIAL MASTER FILE Developing and Maintaining an Inspection-Ready Trial

Master File (TMF) Bryan Souder, Director, TMF Head, MERCK • Understanding the purpose and value of a TMF• Defining what an inspection-ready TMF means to

different regulatory bodies • Evaluating how different regulatory agencies may interact

with the TMF during an inspection • Assessing the current state of your TMF to determine

how to achieve inspection-ready status • Identifying common areas of non-compliance • Developing an action plan to achieve and maintain that

inspection-ready state

2:00 ACADIA CASE STUDY: SHIFTING TO PROACTIVE RISK MANAGEMENT

Examining a Small Company’s Transition From Reactive Issue Resolution to ICH E6 R2 Compliant Proactive Risk Management and a Continual State of Inspection Readiness Maryann Livolsi, MSN, RN, RQAP-GCP, Senior Director, R&D Quality Assurance, ACADIA PHARMACEUTICALSStefan van den Akker, M.Sc., Director, R&D Quality and Risk Management, ACADIA PHARMACEUTICALS • Understanding the conditions and drivers for developing

and implementing a proactive risk-based management approach

• Defining the end goal of inspection readiness and developing a roadmap to get there

• Initiating cultural change to connect the silos and remove the barriers to integrate quality management and study teams

• Shifting attention from for-cause to risk-based, complete independence to integration, CAPAs to quality indicators and top-down reporting to transparent communication at all levels

• Evaluating the transition progress, obstacles that were overcome, best practices and lessons learned

Tuesday, March 20, 2018 | Main Conference Day OneCA

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“Attendees are mostly high-level, resulting in valuable discussions on advanced processes and advanced solutions.”

—Global Head, CQA; GCP and GPvP, ALKERMES

2:45 Networking Break

3:15 PANEL DISCUSSION: GLOBAL REGULATORY INSPECTIONS

Navigating the Global Regulatory Challenges and Changing Landscape for Inspections PanelistsNancy Bitters, Inspection Management Lead, Biopharma, Global Research and Development Quality, EMD SERONO Mike Sobczyk, Senior Director, Compliance, GILEAD SCIENCES Steven Talerico, M.S., Director, GCP Inspection Management (GIM), Global Inspections Lead, Global Clinical Trial Operations (GCTO), MERCK • Evaluating recent and upcoming regulations and

guidances that impact GCP • Discussing the challenges with foreign regulatory body

inspections -Identifying which locations and regulatory agencies are proving to be the most challenging

• Sharing experiences with cross-agency inspections and if that will be an increasing trend

• Addressing the role and impact of “satellite” or remote inspections

• Sharing predictions on how global inspections will continue to evolve

Tuesday, March 20, 2018 | Main Conference Day One

4:15 ROUNDTABLE DISCUSSIONS Each conference participant selects one topic from

the following list to discuss in an intimate setting. You’ll be asked for your topic selections via email a few weeks out from the conference and will have the opportunity to also sign up on site.

1. RISK-BASED AUDITING: Developing Auditing Plans That Focus Efforts on High-Risk Areas

2. QUALITY AGREEMENTS: Understanding the Purpose of a Quality Agreement and How It Differs From a Contract

3. QUALITY MANAGEMENT PLANS: Outlining the Critical Factors of an Effective Quality Management Plan

4. MEASURING RISK: Defining Critical Quality Factors and Metrics to Accurately Assess Risk

5. RISK-BASED MONITORING: Implementing an Effective Risk-Based Monitoring Approach

6. INSPECTION READINESS: Building Inspection Readiness As a Continual State, Not a Process

7. ELECTRONIC INFORMED CONSENT FORMS (eICF): Understanding Expectations and the New Guidance Document Surrounding eICFs

8. REMOTE MONITORING: Discussing Best Practices and Lessons Learned When Monitoring Remotely

9. QUALITY MANAGEMENT SYSTEMS (QMS) AT SMALL COMPANIES: Implementing an Effective QMS When Working With Limited Resources at a Small Company

10. OVERSIGHT OF SUB-CONTRACTORS AND THIRD PARTIES: Reviewing Requirements and Discussing Best Practices for Effectively Overseeing the Quality of Sub-Contractors and Third Parties

5:15 Day One Concludes

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“The GCP Compliance conference delivered on all fronts. The speakers and attendees were knowledgeable and many were influencers or directors of strategy in their respective organizations. The mixed format (talks, workshops, panels, round tables) kept us all engaged and afforded excellent opportunities for the exchange of ideas as well as networking. I hope to be back next year!”

—President, ALGORITHM, INC.

“This was probably the best industry conference I have attended. It was well worth attending and featured many talented speakers who shared their valuable expertise. I learned a great deal.”

—Associate Director, R&D Compliance, BIOGEN IDEC

“One of the most vibrant and interactive conferences I have attended — it was most impressive and I am keen to attend next year!”

—VP Global Quality Assurance, PREMIER RESEARCH

“This is one of the few conferences that continually provides focused discussions amongst a diverse group. Once again I’ve gained many takeaways that my team will look at implementing.”

—Associate Director, Clinical Quality Management, OTSUKA

7:45 Registration and Continental Breakfast

8:30 CHAIRPERSON’S OPENING AND RECAP OF PREVIOUS DAYJoanne Spallone, Global Development Quality Audit Head, NOVARTIS

8:45 MEASURING CLINICAL RISK Outlining a Practical Approach for Identifying and

Measuring Risk in Clinical Trial Operations Denise Calaprice, Ph.D., Senior Consultant, THE AVOCA GROUP • Understanding the purpose of a comprehensive risk

measurement system • Defining the different classes of metrics that should be

used to assess and monitor risk in clinical trial operations • Outlining a practical framework to support

comprehensive consideration of the full pathway to each important clinical trial outcome and the nature of events that could put each at risk

9:30 PANEL DISCUSSION: RISK MANGEMENT TOOLS Evaluating Various Systems, Tools and Processes

That Have Proven Effective for Proactively Measuring, Tracking and Managing Clinical Risk PanelistsRichard Azueta, Head, GxP Audit, NOVARTISCheri Wilczek, President, CLINAUDITS, LLCAdditional Panelists TBD• Sharing what’s worked and what hasn’t to measure,

manage and track risk in clinical operations -Leveraging the trial master file as a risk management tool

-Understanding how audits can be used to assess risk management

• Reviewing effective strategies for leveraging a quality management system to proactively identify risk

10:30 Networking Break

11:00 TRANSCELERATE’S FREE RISK ASSESSMENT CATEGORIZATION TOOL (RACT)

Leveraging RACT to Define, Categorize and Quantify Clinical Trial Risk Karine Julien, Executive Director, Quality Assurance Therapeutic Area Head, Primary Care, MERCK • Understanding RACT as a tool to standardize risk

interpretation to reduce subjectivity, and improve overall risk management awareness in the industry

• Utilizing RACT to define the study Impact, Probability and Detectability (IPD) and completion status

• Evaluating how RACT is customizable and scalable to companies and studies of all sizes

• Visualizing the overall risk assessment of the study to allow for better control and collaboration to take action and mitigate

11:45 PANEL DISCUSSION: TRAINING OPTIMIZATION Evaluating Effective Strategies to Optimize GCP

Training and Mitigate Risk of Non-Compliance Panelists Jennifer Clark, Director, Quality Systems, FERRING PHARMACEUTICALS, INC. Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGENShari Zeldin, BS, CCRC, Clinical Research Compliance Officer, Department of Medicine, UNIVERSITY OF WISCONSIN• Evaluating the effectiveness of traditional training

methods and where it can be improved• Understanding what types of training methods meet

regulators’ expectations • Discussing what new kinds of training programs,

methodologies and harmonized approaches have proven to be effective

• Measuring the effectiveness of training programs and how to demonstrate value and decreased risk

12:45 Lunch

1:45 TESARO CASE STUDY: STANDARDIZING GxP SOPs Establishing a Foundation of Base Processes and

Action Sequences That Are Consistent Across the Organization for Identification and Mitigation of Risk Dan Greenwood, Senior Director, Quality Assurance, TESARO • Recognizing the operational and compliance benefits of

eliminating the variability in SOPs across GxP • Examining the resulting consistent approach to auditing

and vendor communication across the organization • Understanding the procedural and language differences

between GMP and GCP and how they were bridged -Optimizing GCP operations by leveraging efficiencies from GMP practices

• Improving risk identification and mitigation with standardized procedures

2:30 PANEL DISCUSSION: ESCALATION PLANS AND CLINICAL CAPAs

Discussing Effective Procedures for Handling and Resolving Issues Once They’ve Been Identified Panelists Teresa DeVincentis, Senior Director, Clinical Quality Management, CELGENEDawn Lundin, Director, Quality Assurance, MERCK Doreen McGirl, Director, Quality Assurance, CARDIOVASCULAR RESEARCH FOUNDATION• Defining the issue escalation plan, communication plan,

and CAPA and understanding how they relate • Establishing transparency and avoiding a blame culture

to uncover any issues as early as possible • Evaluating who should be involved in establishing and

managing issue escalation plans and CAPAs • Translating past experiences into action items that avoid

recurrence

3:30 CHAIRPERSON’S CONCLUDING REMARKSJoanne Spallone, Global Development Quality Audit Head, NOVARTIS

3:45 Close of Conference

Wednesday, March 21, 2018 | Main Conference Day Two PA

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Media Partners

GROUP DISCOUNT PROGRAMS*Offers may not be combined. Early Bird rates do not apply.*

For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four). This is a savings of 25% per person.

Can 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 212-400-6240.

TERMS AND CONDITIONS:By registering for an ExL Events (“ExL”) 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:Make checks payable to ExL Events and write C1008 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied 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 group discount pricing options.**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.**CANCELLATION AND REFUND POLICY:If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event:• Four weeks or more: A full refund (minus a $295 processing fee) or

a voucher to another ExL event valid for 12 months from the voucher issue date.

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To receive a refund or voucher, please email cancel@exlevents.com or fax your request to 888-221-6750.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 not 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 cancellation on the attendees’ behalf, the credit voucher will no longer be valid.ExL Events does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event.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 Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or any other expenses incurred by registrants.ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers and/or venue.*The opinions of ExL’s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events.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’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting 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 EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY 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 websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

Registration Information

Pricing information for the 9th Proactive GCP Compliance conference

EARLY BIRD PRICING — Register by February 2, 2018

Conference Only .......................................................................................Conference + 1 Workshop .......................................................................Conference + 2 Workshops .....................................................................

$1,795$2,095$2,395

STANDARD PRICING

Conference Only .......................................................................................Conference + 1 Workshop .......................................................................Conference + 2 Workshops .....................................................................

$1,995$2,295$2,595

ONSITE PRICING

Conference Only .......................................................................................Conference + 1 Workshop .......................................................................Conference + 2 Workshops .....................................................................

$2,095 $2,395$2,695

*Includes Sales Tax and Service Fees

SAVE 25%

SAVE 15%

contact our offices at (201) 871-0474.

Please make checks payable to: “PMA"

contact our offices at (201) 871-0474.

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Joanne Spallone, Global Development Quality Audit Head, NOVARTIS

CONFERENCE CHAIR

PFIZER CASE STUDY: RISK MANAGEMENT MODERNIZATION Examining the Evolution of Risk Management Post-ICH E6 R2 and Outlining the Critical Changes That Have Occurred Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

Proactive GCP Compliance9th

Effective Risk-Based Approaches for Optimizing Clinical Quality and Achieving Inspection Readiness

SponsorsKatie Alberta, ALKERMES

Fred Feldstein, JOHNSON & JOHNSON

Simon Trowell,GSK

March 19-21, 2018 | Sheraton Philadelphia University City Hotel | Philadelphia, PA

SENIOR LEADERS PANEL: PROACTIVE RISK MANAGEMENT Understanding How Senior Leaders Are Developing a Culture of Quality to Drive a Proactive Risk Management Approach Panelists

FEATURED SESSIONS

Please make checks payable to: “PMA"