Loading…
This event has ended. Visit the official site or create your own event on Sched.

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

Trk 11: Quality in CT-GCP [clear filter]
Sunday, June 26
 

8:30am

#23: How to Prepare for an FDA Inspection
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial will provide information on how to build quality into a clinical trials program. A record number of FDA inspections, both domestic and international, and OHRP audits have resulted in an increased number of warning letters to sponsors, principal investigators, and IRBs. Using case studies, simulations and actual findings, participants will be able to describe how to approach clinical trials that fully comply with good clinical practice expectations. Participants will also learn about the considerations for noncompliance and the types of findings in an audit that can lead to regulatory problems. This tutorial will describe the role of the FDA and the preparation of a site for an FDA inspection. We will cover the audit from different perspectives and focus on helpful hints and procedural issues regarding what to do in case they are chosen for an FDA inspection. There will be a discussion on how to host the audit and how best to prepare for the actual audit. The audience will be taught some of the do's and don'ts of a successful inspection.

Who should attend?

This tutorial is designed for QA and clinical staff in companies, pharmaceutical/biological companies that are involved in clinical trials and QA activities for clinical research.

Learning Objectives

• Describe how to prepare for an FDA inspection;
• Describe how to respond to an FDA inspection;
• Examine audit findings including their impact on quality research;
• Discuss possible outcomes of an FDA inspection.


Speakers
avatar for Michael Hamrell

Michael Hamrell

President, MORIAH Consultants
Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in pharmaceuticals, contract research, government and biotech industries, in domestic and international regulatory affairs... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am

#222: Valuing the Clinical Trial Patient
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-566-L01-P; CME 1.00; IACET 1.00; RN 1.00

Increasingly, during clinical research development, decisions are made on how to make trials more patient centric, increase patient engagement, and how/when patients will receive their individual research results. In this session, a patient advocate will share perspectives on each of these elements of research design and execution and a bioethicist will share the bioethical considerations for providing individual clinical trial test results to patients. Finally, participants will also hear about a pharmaceutical company's challenges and lessons learned when they decided to thank their clinical trial patients in a national television advertisement.

Learning Objectives

Recognize an increased awareness of clinical trial patients desired benefits from participating in a research study; Describe bioethical considerations when determining whether to provide clinical trial patients with their individual trial test results; Discuss a sponsor company’s experience with thanking clinical trial patients in a television advertisement.

Chair

Jane Perlmutter

Speaker

Bioethical Considerations with the Return of Individual Research Results and Incidental Findings to Clinical Trial Research Participants
Sandra Prucka, MS

Panelist
Deborah Howe



Chair
avatar for Jane Perlmutter

Jane Perlmutter

Founder and President, Patient Advocate
Jane Perlmutter is long-term cancer survivor, involved in a wide-range of advocacy which is rooted in her own experiences, but also informed by her formal training and professional experience. She focuses on clinical trials--ensuring the patient voice is considered in selection of... Read More →

Speakers
avatar for Deborah Howe

Deborah Howe

Associate Director, Vendor Alliance Lead, Bristol-Myers Squibb
Deborah Howe is an Associate Director in Vendor Alliance Management in Global Clinical Operations at Bristol-Myers Squibb. Deborah joined Bristol-Myers Squibb in 2005 and has held positions of increasing responsibility in the area of clinical trial enrollment and engagement. Deborah... Read More →
avatar for Sandra Prucka

Sandra Prucka

Innovation Lead, Eli Lilly and Company
Before coming to Eli Lilly and Company in 2009 I was a clinical genetic counselor and Director of Genetic Counseling Services at the University of Alabama at Birmingham. I have been in the Tailored Therapeutics group at Lilly for 7 years. During this time I completed an internship... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#244: Transforming Clinical Development Through Enterprise Quality Management
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Quality oversight throughout the clinical development life cycle is complex, crosses many functions, and can pose changes in seamlessly communicating and managing quality risks identified along the way. This session will discuss the role of executive leadership in driving and ensuring transparent communication about quality throughout an organization. Additionally, presenters will describe how their organizations have developed and implemented a enterprise quality management approach tailored to their particular context.

Learning Objectives

Identify the benefits of implementing a holistic, clinical-focused quality management system; Discuss how enterprise quality management can be tailored to an organization’s operating context; Recognize how executive leadership can drive a quality-focused culture and timely execution.

Chair

Ann Meeker-O'Connell, MS

Speaker

Executive Leadership Position on Quality
John Hubbard, PhD

Establishing a Quality Management System During Accelerated Growth of a Lean Operation
Coleen Glessner, MBA

Research and Development QA Integrated Quality Strategy: An Approach to Ensuring Quality and Managing Quality Risks Across the Drug Life Cycle
Kevin Grebner



Speakers
avatar for Coleen Glessner

Coleen Glessner

Vice President, R&D Quality and Compliance, Alexion
As Vice President, Head of Research and Development Quality and Compliance at Alexion, Coleen leads the establishment of a quality management system for R&D to assure the highest standards of Quality in ultra-rare diseases. Most recently, she has been focused on implementing sustainable... Read More →
avatar for Kevin Grebner

Kevin Grebner

Director, Clinical Quality Assurance, AbbVie, Inc.
Kevin Grebner is a director in R&D Quality Assurance at AbbVie. Kevin leads the Program Management team responsible for developing and managing the Clinical QA strategy in support of compounds throughout the development life cycle. In his 32 year career at Abbott/AbbVie, Kevin has... Read More →
avatar for John Hubbard

John Hubbard

President and Chief Executive Officer, BioClinica
Dr. Hubbard has held positions of increasing responsibility in the Pharmaceutical, SMO and CRO industries. In his current position as Global President of the Clinical Research Division for ICON plc, he has oversight of more than 4,400 employees conducting 360 projects in 55 offices... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#269: Making Quality Stick: Building a Complete Quality Culture
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

Interactive panel discussions and audience data gathering provides examples of cultural elements to further implementation and sustainment. The audience will leave with ideas to change the mindset from tone at the top to DNA of the broad enterprise. We will discuss the role of culture in quality management systems, how to build a quality culture, and a local non-pharma executive provides perspective on building a quality culture.

Learning Objectives

Discuss examples of successes and challenges in implementing quality management systems including how culture plays a role; Describe methods, tips, and approaches to managing detractors so that you can drive a culture of quality.

Chair

Coleen Glessner, MBA

Speaker

Panelist
Elizabeth Luczak, MBA

Panelist
William Andrew Erhardt, DrMed



Chair
avatar for Coleen Glessner

Coleen Glessner

Vice President, R&D Quality and Compliance, Alexion
As Vice President, Head of Research and Development Quality and Compliance at Alexion, Coleen leads the establishment of a quality management system for R&D to assure the highest standards of Quality in ultra-rare diseases. Most recently, she has been focused on implementing sustainable... Read More →

Speakers
WE

William Erhardt

Vice President, Global Product Development, Pfizer Inc
Bill is a board certified physician in Pediatrics and Pediatric Infectious Diseases and has completed a Staff Fellowship in Regulatory Sciences at the U.S. FDA. Bill joined Pfizer in 1999. Since joining the company Bill has served as a leader in both Clinical Development and Medical... Read More →
avatar for Elizabeth Luczak

Elizabeth Luczak

Vice President, Regulatory Compliance Quality Assurance, Covance Inc.
Elizabeth is Vice President of Regulatory Compliance/Quality Assurance at Covance (division of LabCorp) where she heads a global group of quality assurance professionals providing quality management strategies across clinical development services. Elizabeth has more than 25 years... Read More →


Tuesday June 28, 2016 4:00pm - 5:00pm
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am

#320: Design Thinking to Redesign the Clinical Trial Business Model and Improve Efficiency and Quality of Clinical Trials
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 0.50; IACET 0.50; RN 0.50

Design thinking is a customer-centric approach designers use to solve complex problems. A design mindset is focused on solutions, starting with the perspective of the end-user-and their needs. This session will provide a brief introduction to design thinking, describe its benefits and potential applications to clinical development, and provide a brief example of how one company applied the methodology. The session will be followed by an Engage and Exchange session where participants will apply design thinking concepts hands on.

Learning Objectives

Recognize the basics of design thinking; Describe the case for applying the design thinking methodology in clinical development; Identify areas in which design thinking could be applied in clinical development to enhance trial success and the participant experience.

Chair

Patricia Leuchten


Chair
avatar for Patricia Leuchten

Patricia Leuchten

Chief Executive Officer and President, The Avoca Group
Patricia Leuchten has more than 25 years of experience in the pharmaceutical industry and is a leading authority on global clinical outsourcing and strategic alliances. In 1999, she founded The Avoca Group, a consulting and research firm specializing in clinical outsourcing, alliance... Read More →

Wednesday June 29, 2016 10:30am - 11:00am
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#319: Unlocking the Mysteries of Knowledge Management and Potential Applications for Clinical Development
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Knowledge is a valuable asset that organizations acquire through experience and possess within their employees. Implementing a structured approach to managing knowledge can effectively help achieve desired business outcomes of quality improvements and employee engagement. This session will provide an overview of key principles of knowledge management (KM), discuss elements of a KM framework that can support application within clinical development, and offer ideas on how KM practices can be applied to specific business processes.

Learning Objectives

Recognize key principles of knowledge management and suggested approaches to implementation strategy; Identify a knowledge management framework that can be tailored and applied within a clinical development organization; Discuss how knowledge management may be applied to a specific business process or functions.

Chair

Kathy Salzano

Speaker

Overview of TransCelerate Conceptual Knowledge Management Framework
Christa A. Maurer

Unlocking the Mystery of Knowledge Management: Applying Concepts to a Trial Master File
David William Fryrear, MSc

Application of Knowledge Management in Regulatory Intelligence
Carolyn Louise Hynes, PhD



Chair
avatar for Kathy Salzano

Kathy Salzano

Director, Quality and Continuous Improvement, Merck & Co., Inc.
Kathy Salzano is a Director of the Quality and Continuous Improvement organization at Merck & Co., Inc. Kathy has over 25 years of experience at Merck in various leadership roles supporting the execution and oversight of GCP quality and compliance programs within Clinical Development... Read More →

Speakers
avatar for David Fryrear

David Fryrear

Senior Director, R&D Quality Assurance, AbbVie, Inc.
David Fryrear is a Senior Director in R&D Quality Assurance at AbbVie.  In this role, he is the global head of clinical and pharmacovigilance quality assurance and has responsibility for R&D documentation standards and Quality Knowledge Management.  Prior to joining AbbVie in January... Read More →
avatar for Carolyn Hynes

Carolyn Hynes

Senior Director, Global Regulatory Intelligence, GlaxoSmithKline
Carolyn Hynes is a Senior Director in the Global Regulatory Affairs Department at GlaxoSmithKline and is based in the UK. She leads the Global Regulatory Intelligence team. Prior to joining GSK in 2011, she spent 10 years working at Janssen Research & Development where she was a Director... Read More →
avatar for Christa Maurer

Christa Maurer

Sr. Compliance Specialist, Bristol-Myers Squibb Company
For the past 5 years, Christa has managed a team of Quality Managers responsible for operational risk management and inspection readiness in Asia and the Americas. She previously worked abroad in China and India in her quality role. Her prior experience includes Outsourcing & Contract... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#346: Anticipating and Responding to Challenges in Issue Management
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will include an overview of the Transcelerate Issue Management Conceptual Framework and theTrancelerate Trending and Analytics. We will discuss innovative solutions for managing, monitoring, and mitigating protocol deviations and include a CRO perspective on managing issues and explains how a triage mechanism sorts the plethora of issues to allow focus on issues that matter in the clinical development space, and use of methodologies should bring about a decrease in issues.

Learning Objectives

Describe key aspects of effective, sustainable issue management from triage to effectiveness actions; Identify the benefits of a conceptual approach for proactive planning and implementation of trending issues and the use of predictive analytic activities in risk mitigation and proactive risk management; Discuss the negative impact from protocol deviations and how to proactively and continuously manage this risk; Identify innovative solutions to manage, monitor and mitigate protocol deviations.

Chair

Susan V. Callery-D'Amico, BSN

Speaker

Controlling the Killer KRI: New Solutions to Address Protocol Deviations
Kenneth Wu

FDA Perspective
Jean M. Mulinde, MD



Chair
avatar for Susan Callery-D'Amico

Susan Callery-D'Amico

Vice President, R&D Quality Assurance, AbbVie, Inc.
Susan Callery D’Amico is a pharma leader with extensive experience in quality assurance and clinical development. She is the VP, R&D Quality Assurance, AbbVie, with the mission to drive quality excellence and continuous improvement as a strategic advantage across the lifecycle of... Read More →

Speakers
avatar for Jean Mulinde

Jean Mulinde

Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDA
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Kenneth Wu

Kenneth Wu

Consultant, Kenneth Wu and Associates
Kenneth Wu is the principal consultant at Kenneth Wu and Associates, LLC. He has been consulting for the past ten years. His clients have spanned from large global pharmaceutical companies, biotechnology start ups, medical device companies to contract research organizations (CROs... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#367: Quality at the Edge(s): Design It Right and Keep It Going in Non-Interventional Studies
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

Quality must be assured at all stages of clinical development. Quality planning and risk management begins well before the first protocol for a clinical program is drafted and continues through the life cycle of the product, including postmarking studies. Approaches, including protocols assessment by cross-functional teams and development of control strategies, can identify and address risks before the study starts. At the other end of the clinical development cycle, interest in postmarketing, noninterventional studies is increasing from both the regulatory perspective and their potential support new indications. This session will discuss how these studies have their own set of challenges, yet proper oversight can be achieved through innovative approaches.

Learning Objectives

Describe a framework to reduce risk in early-phase trials; Identify how to drive value from the protocol review stage; Discuss the necessity and challenges of cross-functional risk assessment; Describe the current landscape and expectations for sponsors of non-interventional research; Recognize oversight activities with respect to challenges of postmarketing observational trials; Discuss innovative solutions for overcoming the challenges through risk adapted surveillance activities.

Chair

David William Fryrear, MSc

Speaker

A Proactive QRM Framework that Breaks Down Functional Silos and Drives Higher Quality into Clinical Trials
Tim Strauss, MS

Sponsor Oversight of Non-Interventional Research
Christine R. Sahagian, MS



Chair
avatar for David Fryrear

David Fryrear

Senior Director, R&D Quality Assurance, AbbVie, Inc.
David Fryrear is a Senior Director in R&D Quality Assurance at AbbVie.  In this role, he is the global head of clinical and pharmacovigilance quality assurance and has responsibility for R&D documentation standards and Quality Knowledge Management.  Prior to joining AbbVie in January... Read More →

Speakers
CS

Christine Sahagian

Head, Clinical and Medical QA and Compliance, Shire US Inc
Christine is Head of Clinical and Medical QA and Compliance at Shire. She began her career with clinical trial operations responsibilities at Parexel and CareStat/Battelle CRO. Christine has also had roles in Outsourcing and Clinical QA and Compliance at Vertex, Biogen, and Cubist... Read More →
avatar for Tim Strauss

Tim Strauss

President, Quality Solutions, QI Path


Wednesday June 29, 2016 4:00pm - 5:00pm
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#368: Conducting Trials in China
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will describe some of the unique challenges with conducting clinical trials in China. We will describe approaches and challenges with the application of good clinical practices and include information on how risk-based analyses can be used to select appropriate sites for further review and potential audit.

Learning Objectives

Describe approaches and challenges with application of GCPs in China; Identify how risk-based analyses can be used to select appropriate sites for further review and potential audit.

Chair

Daniel Liu, PhD, MSc

Speaker

Overview of Steps to Doing a Clinical Trial in China
Daniel Liu, PhD, MSc

Risk-Based Monitoring and Enrollment Pattern Analysis: Efficient Approaches for the Assessment Required by CFDA
Wenjun Bao, PhD

Update on Clinical Trials in China
Carol Zhu, MBA



Chair
avatar for Daniel Liu

Daniel Liu

Chief Science Officer, Beijing Clinical Service Center
Daniel Liu, PhD, has served for more than two decades in global clinical research departments, in both management and operations, for such multinational drug companies as Novartis, Pfizer, Sanofi, Schering-Plough, Johnson & Johnson, and Medidata. Dr. Liu has served as Core Expert... Read More →

Speakers
avatar for Wenjun Bao

Wenjun Bao

Chief Scientist and R&D Manager, JMP Life Sciences, SAS Institute Inc.
Dr. Wenjun Bao is a Chief Scientist and R&D manager for JMP Life Sciences of SAS Institute Inc. She has rich experiences in clinical, biochemistry, molecular biology and bioinformatics researches. She has been a research grant review committee member for NIH since 2005 and research... Read More →
avatar for Carol Zhu

Carol Zhu

Senior Vice President and Managing Director, DIA China


Wednesday June 29, 2016 4:00pm - 5:00pm
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA