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11th Pediatric Clinical Trials

Implementing Actionable Strategies that Will Continuously Improve Pediatric Clinical Trial Design

9-11 Jun 2015
Hyatt at the Bellevue, Philadelphia, PA, United States of America

Conference Workshop

Identifying the Role of the Patient to Improve Pediatric Clinical Trial Design and Participation with Pfizer


Why You Should Attend

11th Pediatric Clinical Trials

This marcus evans 11th Pediatric Clinical Trials Conference will take an analytical look at all aspects of pediatric clinical trials from the scientific stages of extrapolating adult data, to regulatory topics on designing Pediatric Investigation Plans (PIPs) and Pediatric Study Plans (PSPs) for EMA and FDA compliance. In addition, we will address the challenges of recruiting patients for these trials while being able to successfully retain them. This conference will bring together leading professionals to discuss key strategies in closing the gap between pediatric ethical challenges to meeting the demands of the global regulatory requirements while continuously improving pediatric care.

The continued FDA and EMA regulations and ethical standards governing pediatric clinical trials continue to be a huge concern in the pharmaceutical industry. High quality and cost effective pediatric clinical trials are difficult to achieve, requiring well qualified and appropriately trained workforce to carry out the highest quality research protocols and adhere to the regulatory infrastructure.

 

Key Topics

  • Conduct Pharmacokinetic and Pharmacodynamic( PKPD) Studies to Improve Drug Design, Delivery and Dosing
  • Utilize Modeling and Simulation (M&S) to Improve Drug Development
  • Extrapolate Adult Data to Pediatric Data to Improve Clinical Trial Design
  • Improve Pediatric Patient Recruitment and Retention to Ensure the Completion of a Clinical Trial
  • Conduct Global Pediatric Clinical Trials to Expedite Results and Achieve Compliance on a Global Scale

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    marcus evans specialises in the research and development of strategic events for senior business executives. From our international network of 63 offices, marcus evans produces over 1000 event days a year on strategic issues in corporate finance, telecommunications, technology, health, transportation, capital markets, human resources and business improvement.

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    Practical Insights From

    Dionna Green, M.D.
    Medical Officer, Pediatric Clinical Pharmacology Staff Office of Clinical Pharmacology Center for Drug Evaluation and Research
    U.S. Food and Drug Administration

    Edress Darsey, PharmD
    Global Pediatric Medical Director, Pediatric Center of Excellence
    Pfizer

    Raafat Bishai, M.D., MSc, DCH
    Senior Director, Clinical Development
    AstraZeneca

    Cheryl Pikora, M.D., Ph.D., MPH, FAAP
    Medical Director/Pediatric HIV Global Lead Global Clinical Research
    Bristol-Myers Squibb

    Lindsay Cobbs, RPh
    Associate Director, Global Regulatory Policy & Intelligence Global Regulatory Affairs FDA Regulatory Liaison Office
    Janssen Pharmaceutical Companies of Johnson & Johnson

    Paul M. Shore
    Associate Director, Clinical Research
    Teva Global Respiratory R&D

    Stacey L. Bledsoe
    Pediatric Capabilities
    Eli Lilly and Company

    Click Here For Full Agenda

    Voice of Our Customers
    • “The greatest benefit of Marcus Evans conferences is strong representation from Industry and the time set aside for question and answer, Panel Discussions & Networking.” –Abbott Molecular
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    Event Contact

    For all enquiries regarding speaking, sponsoring and attending this conference contact:

    Kristiyan Sokolov


    PO Box 24797
    CY-1304 Nicosia
    Cyprus

    Telephone:
    +357 22 849 408
    Fax: +357 22849 394
    Email: KristiyanS@marcusevansuk.com