$2,085 – $6,275

2017 DMC Optimization Summit (EXL)

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Location

Sheraton Philadelphia University City Hotel

3549 Chestnut Street

Philadelphia, PA 19104

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No Refunds

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Description

DESCRIPTION

The 2017 DMC Optimization Summit is an advanced conference on endpoint adjudication. Over the course of this beyond-the-basics forum, attendees will 1) analyze strategies to craft a charter; 2) discuss principles for instituting a Clinical Endpoint Committee (CEC); 3) scrutinize procedures for capturing, managing and monitoring data; and 4) look at guidance documents for adjudication.

Through networking, case studies and panel discussions, professionals from biotech, pharmaceutical, and medical device companies will return to work with the necessary tools and acumen to enhance and streamline endpoint adjudication. This conference will feature an embedded master class on the first morning of the conference, which will clarify the fundamentals of endpoint adjudication.

With two days of educational content and ample networking time, the 2017 DMC Optimization Summit is a must-attend event for professionals aiming to adapt and otherwise improve upon endpoint adjudication best practices.

Top Five Reasons to Attend

  • Learn to balance the FDA’s regulatory requests and demands with the practicality of performing a CEC for a trial
  • Establish guidance documents for adjudication
  • Enhance trial integrity and prepare data for adjudication submission and approval
  • Analyze inconsistencies in adjudication data sets while learning to construct an effective database
  • Comply with regulations through standard submissions

Who Should Attend

This conference is designed for professionals in biotech, pharmaceutical and medical device companies with responsibilities in the following areas:

  • Medical/Clinical Safety
  • Medical/Scientific Affairs
  • Clinical Operations
  • Event Adjudication
  • Biostatistics
  • Pharmacovigilance
  • Protocol Management
  • Clinical Monitoring
  • Data Management
  • Electronic Data Capture
  • Clinical Development
  • Project/Trial Management
  • Regulatory
  • Study Design
  • Informatics
  • Safety Operations
  • Medical Products Safety

This conference is also of interest to:

  • Consultancies
  • Technology Solution Providers
  • Medical Imaging Vendors
  • Data Management Companies
  • Academic Research Organizations
  • Medical Research Institutions
  • Site Management Networks
  • Investigative Site Networks

AGENDA

Day One

Thursday, October 19, 2017

-8:00AM – 9:00AM

Registration and Continental Breakfast

-9:00AM – 9:15AM

CHAIRPERSON’S OPENING REMARKS

-9:15AM – 10:00AM

DISCUSS CHALLENGES THAT THREATEN DMC EFFECTIVENESS AND IMPACT THE STUDY DIRECTLY
Sonia Davis, Director, Collaborative Studies Coordinating, Center, Department of Biostatistics, UNIVERSITY OF NORTH CAROLINA

-10:00AM – 10:45AM

MANAGE THE OPERATION AND FORMATION OF YOUR DATA MONITORING COMMITTEE
Joe Massaro, Professor, Biostatistics, BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH

-10:45AM – 11:15AM

Networking Break

-11:15AM – 12:00PM

SPONSOR INTERACTIONS WITH STATISTICAL DATA ANALYSIS CENTERS (SDACS)
Joseph Scherer, Sr. Associate Director Biostatistics, BOEHRINGER INGELHEIM PHARMACEUTICALS
Dongmei Liu, Associate Director Biostatistics, ACERTA PHARMA

-12:00PM – 1:00PM

Luncheon
PROVIDING THE RIGHT DATA TO ANSWER THE RIGHT QUESTIONS AT THE RIGHT TIME

-1:00PM – 2:30PM

CREATE AN EFFECTIVE DMC CHARTER FOR BETTER OUTCOMES
Frank Rockhold, Professor of Biostatistics, DUKE UNIVERSITY

-2:30PM – 3:15PM

STATISTICAL DATA ANALYSIS CENTER AND THE ROLE OF INDEPENDENT STATISTICIAN
Michael Pencina, Director, Biostatistics, DUKE CLINICAL RESEARCH INSTITUTE

-3:15PM – 4:00PM

RISK-BENEFIT CONSIDERATIONS IN DMC FUNCTIONS
Robert Bigelow, Associate Director, DUKE CLINICAL RESEARCH INSTITUTE

-4:00PM – 4:30PM

Networking Break

-4:30PM – 5:15PM

ENHANCE DMC INTERACTION AND INTERFACE WITH THE SPONSOR
Keith Usiskin, Executive Director, CELGENE

-5:15PM –

Day One Concludes


Day Two

Friday, October 20, 2017

-8:00AM – 9:00AM

Continental Breakfast

-9:00AM – 9:15AM

CHAIRPERSON’S RECAP OF DAY ONE

-9:15AM – 10:00AM

INCORPORATE REGULATORY AUTHORITIES IN THE DMC PROCESS

-10:00AM – 10:45AM

SPONSOR EXPOSURE TO INTERIM COMPARATIVE DATA AND THE POTENTIAL RISKS
Peter Zhang, Ph.D., Head of Biostatistics Department, OTSUKA

-10:45AM – 11:15AM

Networking Break

-11:15AM – 12:00PM

DATA MONITORING COMMITTEES IN ADAPTIVE CLINICAL TRIALS
Lynn Navale, Vice President, Biometrics, KITE PHARMA

-12:00PM – 1:00PM

Luncheon

-1:00PM – 1:45PM

PANEL SESSION: ESTABLISH A SUCCESSFUL RELATIONSHIP WITH PERSPECTIVES FROM DMC MEMBERS

-1:45PM – 2:45PM

DMCS OUTSOURCING OR IN-SOURCE: USE IN EARLY FEASIBILITY STUDIES, TIME FOR A PARADIGM CHANGE?
Wendel Smith, Director Global Safety Transcather Heart Valve, EDWARDS LIFESCIENCES

-2:45PM –

Conference Concludes


Sponsors

The 2017 DMC Optimization Summit is the premier life science event for clinical professionals to connect with CROs, medical imaging solution providers, data management companies and AROs.

Consider sponsoring or exhibiting at this event if your organization is interested in networking and forming lasting relationships with industry executives. Learn more by contacting Andrew Sinetar, Managing Director of Sales, at 212-400-6237 or asinetar@exlevents.com.


ACI Clinical

ACI Clinical was founded in 2001 as an independent specialty group within clinical research. For more than a decade, we have focused on driving best practices in managing Independent Expert Committees – primarily Data Monitoring Committees, Endpoint Adjudication Committees, and Safety Assessment Committees – in order to provide clinical trial sponsors with an effective process based on established best practices, current regulatory thinking and proprietary technologies to ease committee interactions. By combining internal expertise with our global network of more than 500 experts as a source of committee members, ACI delivers strategic guidance and reliable execution for expert committees.

Website: http://www.aciclinical.com/


Partners


MEDtube

MEDtube is an innovative video education platform for health professionals. It allows sharing videos and other materials with a community of more than 110,000 users worldwide, as well as building e-learning courses. The videoteque is updated daily and now contains almost 15,000 videos.

Website: http://MEDtube.net

PharmaLeaders

PharmaLeaders.com is an online environment dedicated to enriching the careers of more than 200,000 life sciences professionals. With breaking news and informative content grouped into one of nine segmented channels, in-depth special reports, job and events postings, and so much more, industry executives, manufacturers, marketers and educators can count on PharmaLeaders for the tools they need to succeed in today’s competitive market environment. For more information, visit us online at www.pharmaleaders.com, write to us at info@pharmaleaders.com or call 888-400-1573, ext. 240.

Website: http://pharmaleaders.com/

pharmaphorum.com

pharmaphorum drives innovation within the pharmaceutical industry, by bringing together healthcare through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.

Visit pharmaphorum today to share, discuss and debate: www.pharmaphorum.com

Website: http://www.pharmaphorum.com

PharmaVOICE

PharmaVOICE magazine, reaches more than 41,000 qualified subscribers and 100,000 users with its digital edition. PharmaVOICE is the forum that allows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry. PharmaVOICE provides readers with insightful and thought-provoking commentary in a multiple-perspective format through forums, topics, and articles covering a range of issues from molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional media resources, including Social Media, WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.

Website: http://www.pharmavoice.com

PM360

PM360 is the premier, must-read magazine for marketing decision makers in the pharmaceutical, biotech, and medical device industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharma marketing professionals to succeed in the complex and highly regulated healthcare environment. The journal’s targeted and insightful editorial focuses on issues that directly impact critical decision making, including: planning and implementation of cutting edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR, and leadership. Additionally, the ‘360’ in our title signifies the combination of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read. By providing the full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.

Website: http://www.pm360online.com/

Technology Networks

Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters. Our global community is made up of over 300,000 researchers and scientific professionals from the life science, drug discover and analytical arenas.

Website: http://www.TechnologyNetworks.com


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS
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Date and Time

Location

Sheraton Philadelphia University City Hotel

3549 Chestnut Street

Philadelphia, PA 19104

View Map

Refund Policy

No Refunds

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