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  • Establishing Global Drug Substance and Drug Product
    Specifications - What the Guidelines Don't Tell You

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Wednesday - Oct 30, 2013 10:00 AM
  • End Time:
  • Wednesday - Oct 30, 2013 11:15 AM
  • Location:
  • Online
  • Learn how to establish global drug substance and drug product specifications that are appropriate to the phase of clinical development and market application, and understand the types of data that are needed to support these specifications.

    Why Should You Attend:
    Establishing appropriate specifications for the drug substance and drug product at the various phases of clinical development can be a challenging task. While regional and ICH guidance’s are available to assist applicants in setting appropriate specifications for a market application, the information in these guidance’s do not necessarily reflect the appropriate level of control needed for early phase clinical studies. Too many or too tight controls established early in development can create unnecessary problems or delays and increase development costs, while insufficient controls may result in clinical holds.
    This session will provide instruction on knowing what to file with the regulatory agencies and when in order to maximize the success of your drug development program. You will learn how important it is to have a thorough understanding of the critical quality attributes of the drug substance and drug product to not only improve your ability to make meaningful decisions during development, but also to be able to establish and justify suitable specifications for your dosage form. This presentation will cover the relevant ICH and compendial requirements and what data is needed to support your drug substance and drug product specifications.

    Areas Covered in the Seminar:
    -ICH guidelines and other relevant sources for setting specifications.
    -Recent changes in compendial requirements.
    -Minimum requirements for drug substances from Phase 1 through market application.
    -Minimum requirement for drug products from Phase 1 through market application.
    -Specifications specific to various types of dosage forms.
    -Regional differences in specifications.
    -Data requirements for setting meaningful acceptance criteria.
    -ICH thresholds.
    -Impurity qualification.
    -Potential pitfalls due to insufficient or inappropriate specifications.
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