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SCDM 2016 Annual Conference

Visit CDISC at the SCDM 2016 Annual Conference


Sheraton San Diego Hotel and Marina

San Diego, CA


CDISC can be found at Booth #101


Exhibition Schedule:

Sunday, September 11, 2016 from 06:00PM to 08:00PM
Monday, September 12, 2016 from 10:00AM to 06:00PM
Tuesday, September 13, 2016 from 10:00AM to 03:30PM


CDISC Bay Area User Network Meeting

Location: South San Francisco Conference Center, 255 South Airport Blvd in South San Francisco, CA

Date: 30 April 2015

Time: 12:30 - 16:30


Please reserve Thursday, April 30 from 12:30 - 4:30 for a meeting of the Bay Area CDISC Network at the South San Francisco Conference Center (see directions below).  Presentations will start at 1:00.


You won’t want to miss this one!  Our first two presenters are from FDA.


Ron Fitzmartin was a co-author of the new Guidances on electronic submissions, which establish the framework and start the clock for requiring standardized data in submissions.  He will explain how the Guidances and specifications work, how they relate to each other, and how to determine the effective dates of requirements for your studies.  Lilliam Rosario, Director of the Office of Computational Sciences, will talk about CDER’s JumpStart program, a service to modernize regulatory review by implementing standards-based processes and software tools to aid review.


It’s hard to overstate the importance of these developments for those of us in the trenches, planning our next submissions.  The Guidances are making CDISC standards a requirement, and JumpStart is already making them indispensable to reviewers.


Many thanks to Genentech and to TalentMine for co-hosting the meeting at the Conference Center, and to Dave D’Attilio (TalentMine) and Patricia Gerend (Genentech) for persuading their management to underwrite it.  Thanks also to Sandra Minjoe (Accenture) for helping to make it happen.


If you plan to attend, please contact jbrega@pharmastat.com so we can get an accurate count for planning purposes. Also, please forward this invitation to your colleagues and friends.


We’re leaving extra time in this meeting for people to chat with colleagues and catch up on news from other companies.  It’s been a while since our last meeting and a lot has changed in the meantime.  We encourage you to come to the Conference Center early to find parking and start your networking.  The room will be open at noon and the first presentation will start promptly at 1:00.


If you cannot attend in person, you have the option of joining our web conference.  Ron and Lilliam will be presenting by web conference, the other presentations will be live at the Conference Center.  To attend the web conference, please email jbrega@pharmastat.com so we can send you the login information.  Please ask for the web conference info so we can respond appropriately.


Click here for more information about the meeting topics, directions and further details.



Boston Area CDISC User Network Meeting


The Boston Area CDISC User Network invites
you and your colleagues to join us for a morning of discussion and
presentations. Pre-registrations help us with planning, so please let us
know if you will be attending.


Please share this announcement with your colleagues. All are invited.



Friday, March 28, 2014



9:30 AM – 12:30 PM



Meeting Room 1F/1G

2 Federal Street

MA 01821

Program Details:

9:30 – 10:30  Oncology Therapeutic Area Standards with panel discussion

  • “Implementing
    Oncology Domains (TU, TR, RS) – Questions and Challenges in
    Representing Additional Clinical Data” by Catherine Mulvaney, PAREXEL
  • Update on the current activities for CDISC Oncology TA development by Amy Adyanthaya, Takeda


10:30 - 11:30  Networking


11:30 – 12:30  End-to-End topics with panel discussion

  • Overview of the new FDA Analysis Data Reviewer’s Guide by Sudhir Singh, EMD Serono
  • Experiences implementing Trial Design


To RSVP for the March meeting and for more information about BACUN, please contact melissa.k.cook@accenture.com


Please share this announcement with your colleagues.


Direction and Arrival Information:

When arriving at Perceptive/PAREXEL

  • Perceptive (2 Federal Street) is the building on the left as you enter the campus.
  • PAREXEL (1 Federal Street) is the building on the right as you enter the campus.
  • There are parking spaces behind 2 Federal and in front and side of 1 Federal.



PhUSE 2013 Events


PhUSE Annual Conference 2013


The PhUSE Annual Conference 2013 will be held on 13th - 16th October 2013 in Brussels, Belgium – register now!


The theme for this year's conference is "Patient Centricity" and it will be held at the Radisson Blu Royal Hotel in the beautiful city of Brussels – benefit from the discounted hotel rate and make your reservation here.


Sponsorship and Exhibitor Opportunities are available and details can be found here.


PhUSE Single Day Events 2013


PhUSE will be running a total of 9 Single Day Events throughout 2013 (4 in Europe and 5 in the US) with locations as follows: (one further United States location still to be confirmed)


  • Frankfurt, Germany – 17th April – register here.
  • Raleigh-Durham, United States – 18th April – register here.
  • Copenhagen, Denmark – 28th May – register here.
  • Beerse, Belgium – 10th June – register here.
  • Boston, United States – 20th June – register here.
  • Basel, Switzerland – 28th June – register here.
  • Ann Arbor-Canton, United States – 12th September – registration will be open soon.
  • San Francisco, United States – 26th September – registration will be open soon.


Come Collaborate with FDA, PhUSE, and CDISC on 18-19 March in Silver Spring, MD!


The aim of the FDA/PhUSE annual Computational Science Symposium (CSS) is to provide updates on collaborations with project groups to improve standards, tools and processes across regulatory review and computational science.


Come Collaborate to Solve Challenges and Look for Opportunities


The annual Computational Science Symposium will bring FDA, industry and academia together for updates and work on collaborations established at previous symposiums and continued throughout the year. Additional collaborative projects have been created to address additional challenges related to the access and review of data to support product development. The groups will work on possible solutions and practical implementations with the goal of helping the broader community align and share experiences to advance computational science. More information about the working groups and their projects can be found here. Register Now!


There are only two weeks left until the Early Bird registration closes (16 February), so Register Now to receive the discounted rate.


Something to Share?


Contribute to the CSS by submitting a Poster.


Share your innovative ideas, cutting edge technologies used within your company, and receive a discount on registration. A poster provides a great way to share and discuss thought provoking concepts.

The San Diego CDISC Users Network (SDCUN) Meeting on 13 December 2012


Location: Pfizer in La Jolla

Time: 12:00 PM to 4:00 PM


Location: Pfizer in La Jolla

Time: 12:00 PM to 4:00 PM



The San Diego CDISC Users Network (SDCUN), is a network that encourages sharing of experiences, education, exchange of ideas, news and career opportunities amongst friends and colleagues in our industry who share an interest in CDISC, submission standards, and regulation.


Based upon the feedback from our last meeting, we have added an additional interactive element to the meeting and are looking forward to the continued sharing and learning amongst our members. Follow the link for agenda and further details.

The End to End Clinical Data Management Conference on 21 & 22 March 2012



Be the first to discover what the future has in store for clinical data management!


The End to End Clinical Data Management conference taking place on 21st and 22nd March 2012 at the Crowne Plaza Philadelphia West, will provide the ultimate platform to network, bounce ideas off each other and ideally produce a new generation of data management experts to lead to our eventual goal: Process Optimization.


End to End Clinical Data Management is the first conference of its kind to offer solutions to the complex and frustrating challenges you face in your everyday work.


Key opinion leaders and experts in the field of clinical data management will be attending including:


  • Katherine Vandebelt, Senior Director Data Sciences and Solutions, ELI LILLY AND COMPANY Samuel Hume, Director, Astra Zeneca
  • Thomas Verish, Senior Director and Head of Data Management, Programming & CSR Writing, PFIZER
  • Andrew Cwiertniewicz, Senior Clinical Trial Manager Clinical Operations, Sanofi Pasteur
  • Carol Ann Schaffer, Project Data Manager Hoffmann, La Roche
  • Darlene Kalinowski, Associate Director EDC Operations, Bristol Myers Squibb ….and many more!


At a time when cost cutting is occurring everywhere, CDM is an area with a huge potential for savings through efficiency and process optimization.


For further information, please visit the Arena International Website or send an email for further questions.

DIA: Investing in Biomedical Informatics for Drug Development and Health Care

12 October - 14 October 2010

Gaylord National Hotel and Convention Center
201 Waterfront Street
National Harbor, MD 20745



THEME A – Application of Biomedical Informatics to Health Care and Pharma

  • Semantic Web
  • Clinical and Health Care Data Quality and Integrity
  • Predictive Analytics
  • Data Repository


THEME B – Policy of Biomedical Informatics in Health Care and Pharma

  • FDAAA and Comparative Effectiveness Research
  • Technology & Data Standards in Public Health
  • Meaningful Use of Electronic Health Care Records
  • FDAAA: Sentinel Initiative



  • Strategies on Developing and Deploying Semantic Linked Data to Biomedical Applications
  • Biomedical Informatics Tools for Preparing Observational Data for Active Surveillance and Outcomes Research



  • Keynote Presentation – Health Informatics by Dr. Mark B. McClellan, Director, Engelberg Center for Health Care Reform, Senior Fellow, Economic Studies, and Leonard D. Schaeffer Chair in Health Policy Studies, The Brookings Institution
  • Keynote Presentation - Integrative Informatics in R&D by Dr. John Reynders, Head of Integrative Neuroscience and Head Informatics Center of Excellence, Janssen Pharmaceutical Companies of Johnson and Johnson 
  • Regulatory/Pharma/Health Care Interactive Panel featuring Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA, and Dr. Mark B. McClellan



  • Ron Fitzmartin, PhD, MBA, Senior Principal Consultant, Decision Analytics, LLC
  • Theresa Mullin, PhD, Associate Director, Planning & Informatics, CDER, FDA


Benjamin Zaitz
Phone: +1 215.293.5803

PhUSE Conference 2010, Berlin

17 - 20 October 2010


PhUSE is the worldwide voice that provides the Life Sciences industry
with the mechanism for sharing knowledge, defining and promoting
industry standards, with a view to furthering the provision of
health-care information through technology

Conference eBrochure

With the explosive growth of standards, the drive to increase efficiency and reduce costs, and the development of new and complex study designs, it is in the interests of most companies and organizations to seek solutions from innovations linked to development of the latest technologies.

  • Attend the excellent pre-conference training courses.
  • Come and hear from exciting industry leaders in the Key Note Presentations - including Dr Charles Jaffe (HL7) and Dr Rebecca Kush (CDISC).
  • Debate in the PhUSE Management Stream including presentations on Clinical Information Environments, Standardization and Business Intelligence from senior executives in companies including Novartis, GlaxoSmithKline and Accenture.
  • Join in with the PhUSE Discussion Clubs covering CDSIC, Clinical Outsourcing and Innovation through Technology.
  • Over 100 presentations across 13 streams, 4 parallel rooms and 3 days.

For more information, please visit the PhUSE Website or contact the PhUSE Office