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Overview

Call for Round Table Discussion Leaders
Submission Deadline: Tuesday, February 28
Details and Guidelines | Submit Your Proposal

For more information please contact Meredith Kaganovskiy, Project Manager, at
Meredith.Kaganovskiy@DIAglobal.org


April 24:
Short Course: New Graphical Methods for Clinical Trials
April 24-26: Forum

*Short Courses require separate registration.
How do we respond to the ever-changing landscape in drug development? This question and many others related to real-world application of advanced approaches and solutions for statistical challenges surrounding the design and analysis of clinical trials will be collaboratively explored at the DIA Statistics Forum. Sessions will focus on regulatory science initiatives and the statistical methodologies and quantitative approaches necessary for providing evidence of the efficacy and safety of new therapies.

Now in its eleventh year, the DIA Statistics Forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs and biologics. This unique forum advances the dialogue between industry, regulatory agencies, and academia.

This program is being developed in collaboration with the Statistics Community.

Approved by the Regulatory Affairs Professionals Society for 12 RAC credits.


Complimentary On Demand Webinar
Multi-Regional Clinical Trials and ICH E17

This webinar discusses ICH guideline E17 that is extremely important to statisticians working on clinical trials spanning multiple regions. It shares a summary of the discussions that took place at the ICH meeting in Japan in November 2016, prepared by event attendees, to begin revising the guideline.

Download recording and presentation materials here.

This Webinar was prepared by members of the DIA Statistics Community.


Highlights
  • Two engaging Keynote Addresses
  • In-depth discussions on the two new FDA Guidances
  • Two interactive half day Short Courses to for even more knowledge-sharing
  • Poster Presentations from researchers across the statistics field
  • 10 Luncheon Round Table Discussions on cutting-edge topics with key thought leaders
  • Town Hall with an expert panel of leaders from industry and regulatory agencies

Who should attend?

Professionals involved in:

  • Biostatistics
  • Pharmaceutical Development
  • Clinical Pharmacology
  • Health Economy
  • Epidemiology
  • Regulatory
  • Academia
  • Government

Learning objectives

At the conclusion of this Forum, participants should be able to:

  • Assess the impact of 21st Century Cures and PDUFA VI on statistical practice
  • Introduce statistical solutions to assess the efficacy, safety, and abuse liability of opioids
  • Discuss recent statistical and clinical trial developments in oncology
  • Describe opportunities for statistical innovation in antimicrobial drug development
  • Outline trends in modeling and decision support in drug development
  • Identify non-traditional data sources and discuss their role in drug development
  • Discuss the synthesis of real-world evidence and randomized controlled clinical trials
  • Propose recommendations for improving the communication among statisticians
  • Summarize the latest trends and updates from regulatory agencies

Program Committee

  • Dionne  Price, PhD
    Dionne Price, PhD Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Jerald S. Schindler, DrPH
    Jerald S. Schindler, DrPH VP, Biostatistics, Merck Research Labs and Adjunct Professor,
    Merck Research Laboratories, United States
  • Frank  Bretz, PhD
    Frank Bretz, PhD Global Head of Statistical Methodology
    Novartis Pharma AG, Switzerland
  • Aloka  Chakravarty, PhD
    Aloka Chakravarty, PhD Director, Division of Biometrics VII, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Lead Mathematical Statistician, Office of Translational Science, CDER
    FDA, United States
  • Pandurang M Kulkarni, PhD
    Pandurang M Kulkarni, PhD Vice President, Global Biometrics & Advanced Analytics
    Eli Lilly and Company, United States
  • Min A. Lin, PhD
    Min A. Lin, PhD Mathematical Statisitician
    FDA, United States
  • Jeff  Maca, PhD
    Jeff Maca, PhD Senior Director, Biostatistics; Advisory Services Analytics
    Quintiles, United States
  • Cristiana  Mayer, PhD
    Cristiana Mayer, PhD Scientific Dir, Statistical Modeling, Methodology, Statistics, Decision Science
    Janssen Research and Development LLC, United States
  • Stephen E. Wilson, DrPH
    Stephen E. Wilson, DrPH Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Amy  Xia, PhD
    Amy Xia, PhD Executive Director, Biostatistics
    Amgen, Inc., United States
  • Lisa M. LaVange, PhD
    Lisa M. LaVange, PhD Director, Office of Biostatistics, Office of Translational Sciences, CDER
    FDA, United States
  • Nevine  Zariffa
    Nevine Zariffa Vice President and Head Biometrics & Information Sciences
    Astrazeneca Pharmaceuticals, United States
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Contact us

Registration Questions?

Send Email
1.888.257.6457
+1.215.442.6100


Complimentary On Demand Webinar

Multi-Regional Clinical Trials and ICH E17


Short Course

New Graphical Methods for Clinical Trials


Agenda and Event Details

Send Email
+1.215.442.6117


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