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    Home Study Details


    Program Type

    Home Study Webcast

    Credits

    1 Contact Hour(s)

    Release Date

    Wednesday, February 1, 2017

    Offline Date

    Saturday, February 1, 2020

    ACPE Expiration Date

    Saturday, February 1, 2020

    Target Audience

    Pharmacist, Pharmacy Technician, Nurse

    Cost

    $30.00

    • Overview

      This class examines the pathways to approval of new drugs, including the full NDA, the 505(b)(2) approval, the ANDA, and the sNDA. The purpose and form of the new drug approval submission is discussed. Postapproval requirements that are implemented as a condition of new drug approval are studied. The class considers the legal and ethical responsibilities of sponsors and investigators who use human subjects in clinical drug trials.

      This webinar can be taken as a standalone live 1 credit hour law (ACPE accredited) but is also a component of the Pharmacy Regulatory Specialist curriculum. To qualify as a PRS, one must enroll in each of the five (5) live or home study PRS pharmacy law webinars given throughout the year and successfully complete twenty-six (26) one-credit monographs. Once all requirements have been completed, the participant must pass a final comprehensive exam (70% or higher) and pay $199 for the recording and issuing of the Pharmacy Regulatory Specialist Certificate.

      Handouts

      • Slide Document :   0798000017017H03_4pp.pdf
      • Slide Document :   0798000017017H03_2pp.pdf

      Financial Support By

      PharmCon
    • Pharmacist

      Describe the obligations of clinical sponsors and investigators of new drugs that are used in trials with human subjects.
      List the programs through which as-yet-unapproved drugs can be made available for therapy on a compassionate basis.
      Discuss the standards and mechanisms for FDA approval of new drugs.

      Pharmacy Technician

      List the programs through which as-yet-unapproved drugs can be made available for therapy on a compassionate basis.
      Discuss the standards and mechanisms for FDA approval of new drugs.
      Describe the obligations of clinical sponsors and investigators of new drugs that are used in trials with human subjects.

      Nurse

      Describe the obligations of clinical sponsors and investigators of new drugs that are used in trials with human subjects.
      Discuss the standards and mechanisms for FDA approval of new drugs.
      List the programs through which as-yet-unapproved drugs can be made available for therapy on a compassionate basis.
    • Activity Type

      Knowledge

      CE Broker

      20-561511

      Universal Activity Number

      Pharmacist 0798-0000-17-017-H03-P
      Pharmacy Technician 0798-0000-17-017-H03-T
      Nurse 0798-0000-17-017-H03-P

      ACPE PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

      PharmCon is an approved course provider for continuing education for nurses by the Florida Board of Nursing. PharmCon is also recognized by the California Board of Nursing as a provider of nursing programs.

      In order to obtain a Statement of Credit, participants must score no less than a 70% on the activity's test and complete a program evaluation.


    HARDWARE REQUIREMENTS
    Standard Windows/Mac System
    iPad or iPhone
    Minimum screen resolution: 1024x768
    Speakers or headphones
     


    SOFTWARE REQUIREMENTS
    Microsoft Edge
    Internet Explorer 8.0 or higher
    Google Chrome
    Safari
    Firefox 3.0.3 or higher


    NETWORK REQUIREMENTS
    Broadband Internet Connection:
    T1, Hi-speed DSL or Cable
    4G cellular connection
     
     

    This continuing education activity is held as copyright by PharmCon, Inc. Through this notice, PharmCon, Inc. grants permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).