• A Bio Europe con ICE

    L’ICE ha previsto un’azione di supporto per start-up innovative che intendano partecipare al BIO EUROPE di Vienna, che si terrà dal 4 al 6 novembre 2013.

    Chi fosse interessato, deve trasmettere i documenti compilati e firmati entro il 5 settembre a: tecnologie@ice.it e in copia per conoscenza a: lifesciences@centroestero.org

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  • CMC WRITING AND SUBMISSION STRATEGIES

    14-15 October, 2013

    Parc Cientific de Barcelona
    Baldiri Reixac 10
    08028 Barcelona, Spain

    Course Topics include:

    • Drug Substance and Drug Product Data in Clinical Trial and Marketing Applications
    • Regulatory CMC Strategies for Global Filings
    • Regulatory Compliance and Change Management Considerations
    • Case Studies

     


    Course Offered by:

    The Center for Professional Advancement
    www.cfpa.com

    In Collaboration with:

    SiTec PharmaBio

    www.sitec-pharmabio.com


    Course Description

    This course will provide in-depth instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and post approval drug applications in the US, Europe and Japan. Additional considerations and integrative approaches for submissions in emerging markets ( Most of the World countries/regions) will be discussed.

    Emphasis will be placed on current national and ICH guidelines, and special considerations for biologics will be discussed.

    Development, manufacturing, analytical testing, controls and stability issues will be presented for solids, parenterals and other dosage forms.

    Overviews of Quality By Design (QbD) submissions and Drug Master Files will be presented. Successful regulatory filing strategies and best practices will be illustrated with examples and case studies.


    Who Should Attend

    This course is intended for individuals responsible for R&D/technical writing/quality management/original and postapproval submissions in pharmaceutical companies, especially those in:

    • Regulatory Affairs

    • QA/QC

    • Process Chemistry

    • Analytical Chemistry

    • Preformulation and Formulation Development

    • Scale-up and Technology Transfer

    Experience of one year or more in one of the above areas is recommended to fully benefit from this course.

     

    Learning Objectives

    Upon completion of this course, you will be able to:

    • Describe the regulatory review processes and health authority expectations through product lifecycle.

    • Analyze and compile CMC data to support CTD clinical trial applications, registration files and post approval submissions in the US and Europe.

    • Explain special writing strategies for Quality By Design marketing applications, Drug Master Files and Most of the World registration dossiers.

    • Identify regulatory compliance issues in agency inspections.