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    Webinar Details


    Event Type

    Live Online

    Date

    Saturday, December 21, 2019

    Time

    9:00 AM - 10:00 AM ET

    Location

    PharmCon Webinar Studio (freeCE.com)

    Credits

    1 Contact Hour(s)

    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.



      Rating

         4.50  out of 5


      Handouts

      Slide Document 17017L03_4pp.pdf
      Slide Document 17017L03_2pp.pdf





      Financial Support By

      PharmCon, Inc
    • Pharmacist

      Discuss the significance of a regulated article being classified as a "new drug"
      List 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 the trials with human subjects

      Pharmacy Technician

      Discuss the significance of a regulated article being classified as a "new drug"
      List 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 the trials with human subjects

      Nurse

      Discuss the significance of a regulated article being classified as a "new drug"
      List 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 the trials with human subjects
    • Repeat Presentation

      This presentation was last given on 9/24/2019 2:00 PM

      Future Airings

      There are no future airings of this activity scheduled at this time.

    • Activity Type

      Knowledge

      CE Broker

      20-561509

      Universal Activity Number

      Pharmacist 0798-0000-17-017-L03-P

      Pharmacy Technician 0798-0000-17-017-L03-T

      Nurse 0798-0000-17-017-L03-P

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

      PharmCon, Inc. 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, attendees must answer poll questions and complete a program evaluation. Attendees may immediately print their Statement of Credit or leave them stored on the website.


    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).




    Computer sharing is NOT permitted due to accreditation guidelines on activity monitoring. Credit is earned by one user per device.