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Pediatric Trial Certification:

A Platform for Success

WEBINAR DETAILS

Date: November 9, 2015

Featured Speakers:

Research studies in infants, children and adolescents require specialized expertise due to increased regulatory requirements, enhanced scrutiny and challenges associated with recruitment and retention in this vulnerable population.

In order to meet this need for specialized expertise, Premier Research has developed a proprietary Pediatric Certificate Training Program to train our employees on core competencies and considerations in the development and conduct of pediatric studies. This mandatory training ensures that our operational team members can provide the insight and resources needed to help sponsors not only meet regulatory requirements and ethical guidelines, but also execute pediatric clinical trials with greater confidence.

Keywords: Pediatric Clinical Trials, Regulatory Requirements

    ABOUT OUR SPEAKERS

    Alison Sampson, Senior Project Director, Premier Research


    Alison Sampson has over 20 years Clinical Research Experience including roles as CRA, Project Manager, Senior Project Manager and Project Director covering phase I – IV global studies. As an experienced Project Manager, she has led both clinical and cross-functional teams. She has worked in all phases of clinical research (I-IV) including global phase III studies as the Global Project Manager. She has experience of a wide variety of therapeutic areas with particular expertise in oncology, medical devices and rare diseases in pediatrics and neonates. Her work experience includes roles in Biotechs, Blue Chip Pharma and CROs.

    Prior to entering clinical research, Dr. Sampson trained as a chemist and she is a Chartered Member of the Royal Society of Chemistry. She achieved Chartered Scientist Status in February 2009 through the Institute of Clinical Research.

    Susan P. Tansey, MD

    Susan P. Tansey, MD, Medical Director, Paediatrics, Premier Research


    Dr. Susan P. Tansey, specialty areas include vaccines, cardiovascular, and oncology, although her initial training was in neonatology and pediatric medicine. She has considerable experience in pediatric clinical research and trial design. Dr. Tansey's expertise in developing detailed clinical development strategies in the pediatric therapeutic field will further strengthen a Premier Research team that brings to the table a wealth of experience in rare disease and pediatric research. Dr. Tansey has considerable international experience in the pharmaceutical industry, having joined Premier Research from TMC Pharma Services Limited, where she was director of medical services. She previously had held research positions at Pfizer, Wyeth Research, and Servier R&D.

    THIS PROGRAM IS INTENDED FOR

    VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:

    • Clinical Affairs
    • Clinical R&D
    • Clinical Research
    • Clinical Pharmacology
    • Clinical Operations
    • Project Management
    • Regulatory Affairs
    • Medical Affairs

    for pharmaceutical, biotechnology and medical device companies.

    OUR XTALKS PARTNER FOR THIS EVENT
     

    Premier Research is a leading CRO serving highly innovative biotech, pharmaceutical and medical device companies. The company has a wealth of experience in rare disease and pediatric research having managed about 100 projects in each area in the last five years alone. Its services include clinical research and regulatory outsourcing in the areas of analgesia; neurology; infectious, cardiovascular, and respiratory disease; dermatology; oncology; and medical devices.

    Premier Research and operates in 84 countries. It employs 1,000+ clinical professionals dedicated first and foremost to fulfilling each customer's requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.



    For enquiries about the archive for this webinar, please contact: info@premier-research.com

     
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