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Trk 22: Engage and Exchange [clear filter]
Monday, June 27
 

10:45am

#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
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:15pm

#147: Interpreting Meaningful Change on PRO Instruments: Methods in Action
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

One aspect of patient-reported outcome (PRO) instrument development that continues to perplex the field is the interpretation of change scores. How much change must be observed on a PRO instrument to be able to say that a patient has experienced a treatment benefit? This session will provide a brief background on commonly-used and novel methods for assigning meaning to PRO score changes, and then attendees will participate in one of three activities where these methods are demonstrated. The goal of the methods demonstrated in each of these three activities is to identify a threshold at which changes on the PRO instrument are deemed meaningful. The first activity will be a mock exit interview where a participant is probed about their experience during a clinical trial and the meaning behind their observed PRO scores. The second activity will be a mock bookmarking exercise where a participant rates hypothetical vignettes as better, worse, or the same as their own condition using items from a PRO instrument. The third activity will be a group exercise on synthesizing results from multiple methods into one responder definition (i.e., the triangulation process). The session attendees will reconvene at the end of these exercises to discuss the value and challenges of each method.

**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

Recognize the value of and challenges with different methods for informing the interpretation of change on PRO instruments by engaging in mock exercises demonstrating these methods in practice.

Chair

Cheryl D. Coon, PhD

Speaker

Facilitator
Scott Komo, DrPH



Chair
avatar for Cheryl Coon

Cheryl Coon

Principal, Outcometrix
Cheryl D. Coon, PhD is a psychometrician with over a decade of experience in the pharmaceutical field. She applies qualitative and quantitative methods to the development and evaluation of PRO instruments. During her years in the field, she has been involved in all stages of instrument... Read More →

Speakers
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →


Monday June 27, 2016 12:15pm - 1:15pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:30pm

#149: EMA's Publication Policy 0070: Best Practices for Implementation
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

In this session, we will share experiences and discuss best practices and solutions to challenges that sponsors are facing with EMA Policy 0070. EMA has provided general guidance but has not been prescriptive. They have also emphasized that this will be a learning process for both EMA and industry with an opportunity to provide feedback along the way. In this session, there will be a brief overview, followed by break-out discussions in small groups. Questions to be discussed include:

• What steps are sponsors taking to ensure that their approach and rationale are consistent from document to document? How may this feedback be shared with EMA to ensure consistency in what is accepted?

• How are companies approaching the anonymization of case narratives?

• How can organizations best write documents bearing in mind downstream CCI and patient de-identifying redaction (without using expensive vendors)? How are organizations managing their internal governance?

• How are companies handling the review of Informed Consent Forms for ‘older’ CSRs that are in scope of Policy 0070?

**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

Describe steps sponsors are taking to ensure their approach and rationale are consistent from document to document; Identify approaches sponsors are using to anonymize case narratives; Discuss how companies are handing the review of Informed Consent Forms for legacy clinical trials.

Chair

Robert Paarlberg, MS

Speaker

Facilitator
Helle M Gawrylewski, MA



Chair
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob created and directed global regulatory... Read More →

Speakers
avatar for Helle Gawrylewski

Helle Gawrylewski

Senior Director, Medical Writing and Alliance Management, Janssen Research & Development, LLC
Head Med Affairs Writing/ MW Alliances, previously director of Early Development and multiple therapeutic area writing at J&J for 17yrs. 2-term MW SIAC Chair, and CDISC Protocol Rep/Glossary Group from 2001. Held positions of increasing responsibility in MW and management for 40... Read More →


Monday June 27, 2016 1:30pm - 2:15pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

9:40am

#205: It’s Not You; It’s Me: Dealing with Team Challenges, Critique, and Criticism
Limited Capacity seats available

Component Type: Workshop
Level: Basic

The life science industry is dominated by teams. High-functioning teams create a dynamic where innovation and productivity flourish; however, even the most motivated teams can have challenging team members or be derailed by uninformative feedback, critique, and criticism. Obtaining team buy-in and actionable feedback can be challenging, especially while endeavoring not to appear defensive or strident. Initially, this session will outline specific team member personalities that can disrupt a project or process. Small groups will focus on strategies for keeping cool, obtaining information, and maintaining team rapport. Attendees will be encouraged to share their examples and solutions within their small group. This will be an interactive session for attendees at all levels.

**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

Discuss the challenges of critique and criticism; Detail strategies for handling challenging team members; Strategize how to create a better rapport.

Chair

Robin Whitsell


Chair
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc.
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 20 years’ experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →

Tuesday June 28, 2016 9:40am - 10:25am
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#228: Increase Value of Clinical Trials Through Impactful Branding
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

This session will offer participants an exciting opportunity to participate in an agency-style strategic brainstorm session designed to help clinical teams improve the value of their study brands by developing a stronger and more purposeful connection to the brand, key study objectives, and various stakeholders.

**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

Demonstrate strategic tools that can lead to more meaningful communications for internal and external stakeholders.

Chair

Neil Weisman

Speaker

Facilitator
Robert Klein

Facilitator
Marie Eckerd



Chair
BC

Barbara Conti

Director, Marketing, Continuum Clinical

Speakers
avatar for Marie Eckerd

Marie Eckerd

Global Feasibility and Recruitment Partner, AstraZeneca
Marie Eckerd is currently a Feasibility and Recruitment Partner at Astra Zeneca. She has lead large global programs through submission across various therapy areas. Previous to AstraZeneca, Marie held leadership positions in Project Management and Data Management with the former Wyeth-Ayerst... Read More →
avatar for Robert Klein

Robert Klein

Chief Strategy Officer, Continuum Clinical
Bob Klein, Chief Strategy Officer of Blue Chip Marketing Worldwide and Continuum Clinical, is dedicated to helping pharmaceutical and biotech companies unearth insights that accelerate clinical trail enrollment and retention. With more than 30 years of experience, Bob is responsible... Read More →


Tuesday June 28, 2016 10:45am - 11:45am
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:00pm

#231: Introduction to Structured Content
Limited Capacity seats available

Component Type: Workshop
Level: Basic

Typically content is created and managed and delivered as large static documents. Content is created multiple times by multiple authors and content is siloed between content creators and product lines. Multiple inconsistent versions of content exist.

Submission-related standards such as eCTD and SPL require structured content; however, these standards only provide the capability to submit content, they do not support the need to more effectively create and manage content. Structured content is today’s best practice for the creation, management, and delivery of content for clinical, labeling, and promotional materials. We will introduce you to the concepts of structured content in a fun, interactive way, then take you through real-world examples so you can understand the inner workings of structure. You will leave with 10 Steps to Structure guidelines.

**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

Discuss the concepts and benefits of structured content.

Chair

Ann Rockley, MLIS


Chair
avatar for Ann Rockley

Ann Rockley

Chief Executive Officer, The Rockley Group Inc.
Ann Rockley has helped pharmaceutical, medical devices, and healthcare providers create intelligent content strategies and adopt structured content management for more than 15 years. She has helped clinical, labeling, and marketing content teams meet the increasing demands of regulatory... Read More →

Tuesday June 28, 2016 12:00pm - 1:00pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#255B: Lost in Translation: The Importance of Data Presentation
Limited Capacity seats available

Component Type: Workshop
Level: Basic

Participants will “learn by doing” how poorly conceived and executed tables and graphs can actually prevent understanding of the science. In contrast, when data presentations are well-designed, they can communicate the key messages of even very large and complex data sets. After a short presentation on the fundamentals of good data presentation, participants will be divided into smaller working groups where they will be challenged with complex and difficult to understand examples of figures and datasets and asked to consider what are the key messages and the best method for communicating them. These real-life data examples are guaranteed to open eyes and enlighten. After each exercise, the groups will come back together to discuss, share, and analyze the messages and their presentations, and conclude with a summary of lessons learned.

**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

Demonstrate how to change uninformative tables and graphs into data presentations that communicate clearly.

Chair

Barry Drees, PhD


Chair
avatar for Barry Drees

Barry Drees

Senior Partner, Trilogy Writing & Consulting
Barry Drees received his PhD in molecular genetics at the University of California, San Francisco. Following his postdoctoral work as a fellow of the National Institute of Health, he worked as a medical writer at Hoechst/Aventis for 12 years. Barry is a frequent speaker on medical... Read More →

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

4:00pm

#278: Real Life Application of Risk-Based Monitoring
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

This session will include a facilitated discussion about common application experiences applied through case-based learning and will encourage audience members to share similar or different experiences in their risk-based monitoring implementations.

**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

Explain how to apply the implementation lessons of risk-based monitoring to your own situation.

Chair

Brett Wilson

Speaker

Facilitator
Lisa Horne-Lucero, BSN

Facilitator
Kate Owen



Chair
avatar for Brett Wilson

Brett Wilson

Head, Monitoring Excellence, Bristol-Myers Squibb Company
Brett Wilson, BSP, is Head of Monitoring Excellence at Bristol-Myers Squibb and leads both Risk Based Monitoring and eSource initiatives with TransCelerate BioPharma. Within BMS, Brett is responsible for ensuring an accountable and sustainable adaptive monitoring model focused on... Read More →

Speakers
avatar for Lisa Horne-Lucero

Lisa Horne-Lucero

Consultant, RBM Operations, Clinical Risk Management, Eli Lilly and Company
Lisa is an RBM Operations Consultant in Eli Lilly’s Clinical Risk Management organization. She develops and implements RBM processes, procedures and training as she guides study teams through the RBM implementation process. She has been a key leader in the implementation of RBM... Read More →
avatar for Kate Owen

Kate Owen

Vice President, Clinical Trial Management, Novo Nordisk Inc.
Kate is the Vice President of Clinical Trial Management at Novo Nordisk (Princeton, NJ) with 22 years’ experience within the biotech, pharmaceutical and CRO space. Her leadership has led to improved productivity, cost-effectiveness, quality and staff morale. She sponsors the Novo... Read More →


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

9:40am

#305: MedDRA: Use in the Review of New Drug Applications at the FDA
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

This session will provide an overview of the use of MedDRA and Standardised MedDRA Queries in the review of New Drug Applications. It will include practical exercises designed to promote discussion of best practices and solutions to challenges in premarketing pharmacovigilance. Participants will gain a valuable insight into how FDA analyzes MedDRA data, with an emphasis on data quality.

**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.

Chair

David Richardson, MD

Speaker

Facilitator
Christopher Damian Breder



Speakers
avatar for Christopher Breder

Christopher Breder

Medical Officer, Office of New Drugs, CDER, FDA
Dr Breder is Medical Officer at the FDA with a focus on neurological disorders. He serves as the FDA Topic leader on the ICH team that maintains the MedDRA Points to Consider document. Prior to his employment at the FDA, Dr Breder served in several leadership roles in industry. He... Read More →
avatar for David Richardson

David Richardson

Owner, Richardson M.D. Consulting, LLC
David W. Richardson, M.D. is a drug safety/pharmacovigilance consultant, based in Atlanta, Georgia. Dr. Richardson is an adult neurologist; he attended Harvard College and University of Pennsylvania School of Medicine. He is a part-time consultant for the MedDRA Maintenance and Support... Read More →


Wednesday June 29, 2016 9:40am - 10:25am
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#328: The Ethics of “Big Data” Biomedical Science
Limited Capacity seats available

Component Type: Workshop
Level: Basic

Drug developers, regulators, and payers are increasingly relying on large, linked, and networked databases to discover and test new therapies; inform regulatory and funding decisions; monitor therapies in practice and fine tune therapeutic approaches. The use of such “big data” resources is scientifically exciting but raises a number of ethical issues relating to participant consent and confidentiality; ownership, and benefit sharing; and effects on clinical trials, regulatory and funding processes, and the physician-patient relationship. This session will include an exercise to explore the ethical issues raised by biomedical research that uses “big data” resources.

**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

Recognize that there are many different kinds of “big data” with many different applications in public health and biomedicine; Discuss the key ethical issues arising from research involving “big data,” including consent, confidentiality, ownership, benefit sharing, and effects on clinical trials, regulatory and funding processes and the physician-patient relationship; Express whether, when and how “big data” research should be conducted so it is ethically sound.

Chair

Wendy Louise Lipworth


Chair
avatar for Wendy Lipworth

Wendy Lipworth

Senior Research Fellow, Centre for Values, Ethics and the Law in Medicine, University of Sydney
Dr Wendy Lipworth is a medically trained bioethicist and qualitative social researcher from the Centre for Values, Ethics and the Law in Medicine, University of Sydney, Australia. Her program of research focuses on the ethics and politics of biomedical innovation, with a particular... Read More →

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

12:00pm

#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
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#354: Protocol Optimization: Making It Real
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

Increasing complexity in clinical trial protocols makes implementation and reporting difficult. The lack of consistency across protocols compounds the issue. TransCelerate BioPharma Inc. has released a Common Protocol Template that provides a common structure and model language. The common protocol template is a foundational element in the longer-term movement towards an electronic protocol. Participants will rotate through interactive, discussion-based stations to learn about the Common Protocol Template and inform its future development. Topics will include:


• Implementation: benefits and overcoming common challenges
• Technology Enabled Edition: how content reuse and metadata capture is possible today
• Experience from the Trenches: lessons learned and FAQs about the template.

**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

Explain the value of harmonizing protocols across industry; Discuss the TransCelerate Common Protocol Template; Identify implementation challenges and strategies for overcoming them.

Chair

Robert L. Ferendo

Speaker

Facilitator
Virginia Nido, MS

Facilitator
Stacy J. Tegan

Facilitator
Bryan Yee



Chair
avatar for Robert Ferendo

Robert Ferendo

Consultant-Process & Technology, Eli Lilly and Company

Speakers
avatar for Virginia Nido

Virginia Nido

Head, Industry Collaborations, Genentech, A Member of the Roche Group
Virginia Nido is the Global Head of Industry Collaborations Management for Roche Product Development. In this role, Ms. Nido is accountable for strategic oversight of external collaboration initiatives. Ms. Nido serves on the Oversight Committee of TransCelerate Biopharma and the... Read More →
avatar for Stacy Tegan

Stacy Tegan

Sr. Manager, Regulatory Technology Consulting, Accenture
Stacy Tegan brings 20+ years of experience in the Pharmaceutical industry with expertise in Regulatory Operations, Clinical Development Processes, and Project Management. Starting in Regulatory Operations, she managed sponsor and outsourced publishing teams and led multiple transitions... Read More →
avatar for Bryan Yee

Bryan Yee

Strategic Planning and Operations Senior Manager, Amgen Inc.
Over the past 10 years Bryan has led global cross-functional teams in the design and implementation of large-scale transformation initiatives at Amgen. He is currently a member of a team focused on creating a best-in-class clinical development capability to bring more medicines to... Read More →


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

3:15pm

#356: Let's Enjoy Global Stakeholder Management
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

If you are sometimes having trouble identifying and managing your stakeholders in other regions, especially in East Asia, then please join us! In this session, which corresponds to “Global Stakeholder Management: Across the Ocean Between East and West” (Wednesday, June 29, 10:30 AM), we will have the opportunity answer your questions as well as share experiences, best practices, and advice.

**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

Discuss practical advantages and limitations of stakeholder management implementation.

Chair

Atsushi Tsukamoto


Chair
avatar for Atsushi Tsukamoto

Atsushi Tsukamoto

Vice President, New Drug Regulatory Affairs, Daiichi Sankyo Co., Ltd.
Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects... Read More →

Wednesday June 29, 2016 3:15pm - 4:00pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA