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Monday, June 27
 

8:30am EDT

#101: Opportunities for Improving Informed Consent of Clinical Research Volunteers
Limited Capacity seats available

Component Type: Symposium
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

Learn about new strategies for improving the informed consent process. Recommendations and tools for re-focusing on the informed consent process will be provided. Examples, opportunities and future directions related to use of eConsent will be shared. Finally, the challenges and solutions for consenting adult and pediatric patients in antibacterial clinical trials will be discussed.

Learning Objectives

Describe recommendations for improving the informed consent process in clinical research; Discuss the TransCelerate eConsent project including benefits for research volunteers as the industry moves from paper to eConsent; Recognize actions that can be taken to encourage site eConsent adoption and proactively address issues that commonly surface during eConsent site implementation; Identify opportunities for improving consent in challenging situations.

Chair

Jennifer Lentz

Speaker

Transforming Informed Consent: Initiatives of the Clinical Trials Transformation Initiative and TransCelerate BioPharma, Inc.
Jennifer Lentz

Engaging Investigators and Site Staff in Adoption and Implementation of e-Consent: A World View
Susan Brink, DrPH

Applicable Lessons Learned from the CTTI Antibacterial Drug Development Program
Pamela Tenaerts



Chair
JL

Jennifer Lentz

Consultant, Global Informed Business Lead, Eli Lilly and Company
Jennifer Lentz has been the Global Informed Consent Business Lead at Eli Lilly and Company for the last 4 years. She has been involved in consent projects with Clinical Trials Transformation Initiative, Transcelerate, and Innovative Medicines Initiatives. Prior to joining Lilly, Jennifer... Read More →

Speakers
avatar for Susan Brink

Susan Brink

Executive Vice President, e-Consent Products and Services, Enforme Interactive
Dr. Brink has been involved in creation of e-consent since 2003. As PI on a NIH SBIR grant to develop an electronic informed consent, she led the team in vision, guidance and research for SecureConsent. Her Enforme portfolio includes expansion of SecureConsent e-consent system into... Read More →
avatar for Pamela Tenaerts

Pamela Tenaerts

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States
Pamela Tenaerts is the Executive Director at the Clinical Trials Transformation Initiative (CTTI) where she works closely with the Executive Committee to develop and implement strategies to accomplish CTTI’s mission. She provides senior level oversight of the day-to-day operations... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium

8:30am EDT

#103: Decision Tools to Drive Efficient Recruitment and Retention: Making Recruitment a Science
Limited Capacity seats available

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

In this session, we will display a tool that helps integrate recruitment planning into the fabric of a trial’s operational design. We will also debate the most appropriate usage of the tool and how to integrate it into the planning process.

Learning Objectives

Describe a new tools developed by sponsors to determine the best recruitment strategy for any given protocol; Show the impact these tools have had on developing budgets and tactics for recruitment planning; Discuss the positives and potential pitfalls of using these tools.

Chair

James Kremidas

Speaker

Matchmaking: Systematizing Best Fit Tactics for Study Needs
Lewis Millen

The Art and Science of Site Level Recruitment Planning: Tools, Tactics, and Tips?
Beth D. Harper, MBA



Chair
avatar for James Kremidas

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)
Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. He was Senior Vice President, Patient Recruitment, at two different large CROs for over six years where he and his team were responsible for developing and implementing... Read More →

Speakers
avatar for Beth Harper

Beth Harper

President, Clinical Performance Partners, Inc.
Beth is the President of Clinical Performance Partners, Inc. a clinical research consulting firm specializing in enrollment and site performance management. She has passionately pursued solutions for optimizing protocols, enhancing patient recruitment and retention and improving sponsor... Read More →
avatar for Lewis Millen

Lewis Millen

Operational Intelligence Leader, Roche Products Limited


Monday June 27, 2016 8:30am - 9:45am EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am EDT

#144: Root Cause Analysis: Getting to ‘Why’ When Something Goes Wrong in Your Trial
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

It is easy to get lost in the terminology around understanding the why of a problem – audit finding, response, CAPA, root cause analysis, fishbone diagram. This practical session will get you working with others on an example issue, using some basic ideas on root cause analysis and trying them out. You will learn the basics of getting to why without worrying about the terminology. Getting to the why when something goes wrong on your trial means you have the best chance of determining ways to stop the same thing impacting your trial (or another one) again. It’s a key part of a learning organization.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Apply root cause analysis techniques to determine probable root causes of an issue (such as from an audit finding); Explain the purpose of root cause analysis.

Chair

Keith John Barber

Speaker

Facilitator
Helen Howitt



Chair
avatar for Keith Barber

Keith Barber

Executive Director, INC Research
Keith Barber has worked in Quality, Process, Training and Clinical management positions for over 20 years. He currently manages INC's Process Quality Management department, which includes CAPA management, controlled document management and internal GXP consultancy. Keith has also... Read More →

Speakers
avatar for Helen Howitt

Helen Howitt

Director, Process Quality Management, INC Research


Monday June 27, 2016 10:45am - 11:45am EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am EDT

#124: Risk-Based Monitoring in Clinical Trials
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-518-L05-P; CME 1.25; IACET 1.25; RN 1.25

This symposium will examine the implementation of risk-based monitoring strategies in clinical trials and their impact on site performance, patient safety, data integrity, and study quality.

Learning Objectives

Discuss how risk-based monitoring (RBM) can help investigator sites improve overall site performance, with higher efficiency and improved patient safety; Describe best practices in site/CRO partnering to successfully drive efficiencies and improve oversight of patient safety and data quality; Identify the importance of planning the RBM strategy in order to make it actionable.

Chair

Ellen Kelso

Speaker

How to Successfully Plan and Implement a Risk-Based Monitoring Strategy
Francois Torche, MBA

Risk-Based Monitoring: What Does It Mean for Clinical Study Sites?
Jill Collins

The Impact of Risk-Based Monitoring on Site Performance: Reducing Risks While Improving Patient Safety and Study Quality
Robin Douglas, MA



Chair
avatar for Ellen Kelso

Ellen Kelso

Executive Director, Chesapeake IRB
Founder, managing member & CEO of Goodwyn IRB, Ellen Kelso is recognized for her experience & expertise in clin. trial mgt & reg. affairs. Has provided educ., consultation & services to the pharma industry supporting clinical research & regulatory strategies, submissions & compliance... Read More →

Speakers
avatar for Jill Collins

Jill Collins

Executive Director, Global Operations management, Innovation, INC Research
Jill Collins, Executive Director, Global Operations Management, Innovation at INC Research, with 20 years of experience in clinical operations, leads the development of transformative approaches to trials with a focus on data-driven process optimization, including INC’s RBM solution... Read More →
RD

Robin Douglas

Site Solutions Director, Site and Patient Networks, Quintiles
Robin Douglas has 22 years of clinical research experience, including 16 years as a site manager / administrator. Currently Robin serves as Site Solutions Director at Quintiles. Her core responsibility is to ensure an enhanced site experience when working with Quintiles which includes... Read More →
avatar for Francois Torche

Francois Torche

Chief Executive Officer, CluePoints
François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 19 years in the pharmaceutical industry, he has held positions as statistical programmer, developer and IT project leader for companies such as GSK, UCB and IDDI. During... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium

10:45am EDT

#137: Using Technology to Make Trials Accessible to More Clinical Trial Participants
Limited Capacity seats available

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

As clinical care moves toward increasingly patient-centric models, research must also account for the participant’s perspective in order to maximize clinical trial recruitment, enrollment, adherence, and completion. Quality indicators that capture information about participant preferences and challenges can be used to inform clinical trial feasibility. Leveraging mobile technologies, in particular, can potentially empower a participant population, while emphasizing participant understanding of the commitment involved and, simultaneously, easing burdens on sites and study staff. This session will explore mobile applications, including eConsent, and at-home clinical trials, as potential tools—even providing the capacity to conduct remote trials—to spur participation through increased participant engagement, convenience, and satisfaction.

Learning Objectives

Identify emerging technologies and methods for both achieving efficiencies and optimizing effectiveness in clinical trial design; Evaluate quality metrics related to participant satisfaction and challenges associated with study implementation; Assess technologies and methods for their impact on clinical trial feasibility from a participant-focused perspective; Describe how to create an integrated plan, leveraging available technologies and methods, to improve the success of clinical trials.

Chair

Linda M Coleman, Esq, JD

Speaker

Mobile Clinical Trial Technologies: Use Cases and GCP Compliance Considerations
Philip J. Coran, Esq

Mobile Technology in Research: A Compliance and Ethics Review Perspective
Linda M Coleman, Esq, JD

Mobile Health Applications and eConsent: A Sponsor’s Perspective
Kevin Hudziak, MS



Chair
LC

Linda Coleman

Director, Human Research Protection Program, Yale University
Ms. Coleman is the Director of the Human Research Protection Program at Yale University. Prior to joining Yale, she was the Vice President of Regulatory and Legal Affairs at Quorum Review and an attorney at Bennett Bigelow & Leedom. Ms. Coleman has experience in research ethics, regulatory... Read More →

Speakers
avatar for Philip Coran

Philip Coran

Principal, Global Compliance and Strategy, Medidata Solutions
Phil Coran is a Principal of Global Compliance & Strategy at Medidata. Prior to joining Medidata, Phil was at Pfizer for 12 years in the Medical Quality Assurance and Internal Audit groups. From 1999-2001, Phil was an IT Risk Consultant at Deloitte & Touche & Arthur Andersen accounting... Read More →
avatar for Kevin Hudziak

Kevin Hudziak

Consultant, Innovation Lead, Eli Lilly and Company
Kevin works in the Clinical Innovation group at Lilly as an Innovation Lead focused on implementing eConsent and other technologies across the Lilly portfolio. Kevin participated in the CTTI Informed Consent project and is currently a member of the TransCelerate eConsent project... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 11: Quality in CT/GCP, Session
 
Tuesday, June 28
 

10:30am EDT

#207: Advancing the Appropriate Use of Mobile Clinical Trials: The Clinical Trials Transformation Initiative
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-513-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session, we will present preliminary findings and future project plans for the Clinical Trials Transformation Initiative's Mobile Clinical Trials Program, comprised of three project areas: legal and regulatory issues, scientific and technological issues, and stakeholder perceptions.

Learning Objectives

Describe objectives, methods and preliminary findings of the Clinical Trials Transformation Initiative's Mobile Clinical Trials Program; Identify barriers, real and perceived, that inhibit widespread adoption of mobile technology in clinical trials; Consider opportunities to mitigate identified barriers to adoption.

Chair

Kristen Miller

Speaker

Clinical Trials in the 21st Century : If They Could Put a Man on the Moon…
Robert A. DiCicco, PharmD

Patient Perspective
Cynthia Geoghegan



Chair
avatar for Kristen Miller

Kristen Miller

Health Scientist Policy Analyst, Office of Medical Policy, CDER, FDA
Kristen Miller helps to lead FDA’s activities with Clinical Trials Transformation Initiative (CTTI), a public private partnership between FDA and Duke University that identifies and promotes practices to increase the quality and efficiency of clinical trials. She joined the FDA... Read More →

Speakers
avatar for Robert DiCicco

Robert DiCicco

Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over... Read More →
avatar for Cynthia Geoghegan

Cynthia Geoghegan

Patient Representative, Patients and Partners LLC
A patient advocate and cancer survivor with decades of health policy, communications and capacity-building experience, Cindy Geoghegan founded Patient & Partners to ensure that the patient perspective is strategically integrated into industry, academic, government and non-profit efforts... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm EDT

#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 EDT
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 11: Quality in CT-GCP, Session
 
Wednesday, June 29
 

10:30am EDT

#307: Mythbusting Site Productivity: Referral Practices and Untapped Site Options
Limited Capacity seats available

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

Site selection continues to be a challenge for study teams. How do you find the best sites, and how to you ensure they have access to the patients and can produce the data quality you need for your trials? In this symposium, we will share results of an extensive survey of physicians to learn about their actual referral patterns for clinical trials and the barriers/perceptions they have about referring patients to trials. We will also explore how to expand the sites we select beyond the typical academic center. How might community networks be better leveraged? How might we partner with patient advocacy groups to identify new and well suited sites to include in our trials? Pulling it all together - how can we then engage physicians other than the research sites to refer patients to our trials? And what information will be useful to both traditional and not so traditional sites to help them successfully enroll trials?

Learning Objectives

Compare data from physicians about clinical trial referral practices and perceptions; Describe experiences and lessons learned from partnering with a community network of physicians as a clinical trial site.

Chair

Jane E. Myles, MS

Speaker

Integrating Overlooked Health Care Networks into Clinical Trial Site Selection
Sowmya Banda

Study of Health Care Provider Perceptions and Patient Referral Practices
Mary Jo Lamberti

How Advocacy Is Impacting Site Productivity
David LeDuc



Chair
avatar for Jane Myles

Jane Myles

Head, Decentralized Trials Implementation, Covance
Jane is driving the global impmenentation of decentralized trials at Covance with a team of tech and trial experts. She is the Founder of JemTech consulting and the former Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation... Read More →

Speakers
SB

Sowmya Banda

Graduate Intern, Clinical Trial Planning and Operations, Bristol-Myers Squibb Company
Sowmya is the Clinical Trial Planning & Operations Graduate intern at Bristol-Myers Squibb. She supports Feasibility Analytics as well as Diversity & Patient Engagement within clinical operations. She is also a PharmD Candidate at the Ernest Mario School of Pharmacy at Rutgers Un... Read More →
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Associate Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
Mary Jo Lamberti is on the faculty at Tufts University and is Associate Director of Sponsored Research at Tufts Center for the Study of Drug Development (CSDD). She leads multi-company sponsored research studies and has extensive experience conducting research on biopharmaceutical... Read More →
avatar for David LeDuc

David LeDuc

Senior Director of Strategic Alliances, Addario Lung Cancer Medical Institute
As Sr. Director of Strategic Alliances, David leads efforts to identify and cultivate potential member institutions while leading the development of innovative partnerships to advance ALCMI's mission and accelerate the pass of research.  David has a breadth and depth of experience... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium

12:00pm EDT

#331: Applying Design Thinking to Clinical Development: Human-Centered Approaches to Improve Quality and Efficiency
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

In this fast-paced, highly interactive session, we will:

• Provide participants with a basic overview and vocabulary for human-centered design methodology through a brief didactic presentation;

• Through brief case studies, communicate examples of how human-centered design methods have been utilized by clinical development R&D organizations via a pharmaceutical industry consortia and by individual pharmaceutical companies to progress challenges and initiatives;

• Stage an interactive dialogue amongst participants on challenges and considerations specific to clinical development when integrating design thinking methods into areas of opportunity for improved efficiency and quality outcomes.

Participants will be challenged to rapidly learn the basic concepts of human-centered design, integrate their subject matter expertise to identify potential challenges and past analogous experiences, and develop creative solutions to using human-centered design as a catalyst for improving how industry solves common challenges in clinical development. Having achieved the above objectives, participants will leave with take-away materials to facilitate immediate integration of design thinking methods into their respective projects and initiatives.

This session is coordinated with “Design Thinking to Redesign the Clinical Trial Business Model and Improve Efficiency and Quality of Clinical Trials” (Wednesday, 10:30-11:00 am, Track 11).

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Identify areas where human-centric design approaches have or could be leveraged within clinical research to progress challenges and initiatives; Explain strategies for avoiding or overcoming common challenges to introducing design thinking methods into research organizations; Build a network of like-minded professionals who are interested and/or active in using design thinking in their projects and initiatives within clinical research and development.

Chair

Dennis Salotti, MBA, MS

Speaker

Facilitator
Steven B. Whittaker

Facilitator
JoAnn Muir



Chair
avatar for Dennis Salotti

Dennis Salotti

Chief Operating Officer, The Avoca Group
With 20 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis Salotti's experience spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations, and strategic management. Prior to Avoca, he was Director... Read More →

Speakers
avatar for JoAnn Muir

JoAnn Muir

Global Head Franchise Quality Assurance, Novartis Pharmaceuticals Corporation
JoAnn Muir is Global Head Quality Assurance/Vendor Oversight at Novartis. JoAnn has 20 years’ experience in clinical research and has spent her career in clinical trial management, drug development, and quality assurance. She supports clinical teams by providing regulatory compliance... Read More →
avatar for Steven Whittaker

Steven Whittaker

Executive Director, Quality Consortium, The Avoca Group
Steven Whittaker, Executive Director, Avoca Quality Consortium (retired from Eli Lilly and Co.) , consults for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution... Read More →


Wednesday June 29, 2016 12:00pm - 1:00pm EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 22: Engage and Exchange, Workshop

2:00pm EDT

#337: Overcoming Deficiencies in the Oversight of Outsourced Clinical Programs: Collaboration and Utilization of Industry Leading Guidelines and Tools
Limited Capacity seats available

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

This forum will present data on industry challenges/opportunities for improvement in sponsor oversight of CROs and service providers. Collaborative efforts for developing and implementing industry leading practice guidelines and tools will be shared.

Learning Objectives

Discuss the oversight requirements and expectations from regulators, sponsors and providers; Explain the collaborative effort to develop and utilize industry leading practices for the oversight of outsourced clinical programs; Demonstrate examples of vital guidelines and tools for achieving top-tier success through appropriate oversight practices.

Chair

Mike Collins, PhD

Speaker

Panelist
Grace M Crawford, MS

Panelist
Joseph Anthony Fortunato

Panelist
Steven B. Whittaker



Chair
avatar for Mike Collins

Mike Collins

Head of R&D Global Vendor Management, Alexion
Mike graduated from the University of Sheffield in the UK with a degree in Genetics. After an MSc in Applied Genetics; he completed his doctorate at the University of Birmingham. Mike has worked in clinical development for over 25 years at Hoechst and Pfizer. He is currently Head... Read More →

Speakers
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality and Compliance, AstraZeneca
Grace joined MedImmune in April 2015 to lead the Clinical Quality & Compliance function. Prior to joining MedImmune, Grace spent over 21 years at ICON where her main focus was leading the Clinical QA Department. She is active in industry participating in forums such as the Society... Read More →
avatar for Joseph Fortunato

Joseph Fortunato

Senior Vice President, Corporate Quality Assurance and Compliance, inVentiv Health Clinical
Joseph Fortunato has over 37 years of experience in the healthcare industry with leadership roles in large pharma and large CROs. _x000D_ _x000D_ Joe joined inVentiv Health Clinical in 2014 as the Sr. VP of Corporate QA and is responsible for leading a group of Quality Assurance professionals... Read More →
avatar for Steven Whittaker

Steven Whittaker

Executive Director, Quality Consortium, The Avoca Group
Steven Whittaker, Executive Director, Avoca Quality Consortium (retired from Eli Lilly and Co.) , consults for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model-Outsourcing, Forum

4:00pm EDT

#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 EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA