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PRS 103.1: New Drug Approval Process

Event Type

Live Online

Date

Thursday, February 7, 2019

Time

10:30 AM - 11:30 AM ET

Location

PharmCon Webinar Studio (freeCE.com)

Credits

1 Contact Hour(s)

Target Audience

Nurse, Pharmacist, Pharmacy Technician

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


    Handouts

    Slide Document:   17017L03_4pp.pdf


    Slide Document:   17017L03_2pp.pdf

    Financial Support By

    PharmCon, Inc.
  • 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


    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

  • Repeat Presentation

    This presentation was last given on Tuesday, November 6, 2018

    Future Airings

    None

  • Activity Type

    Knowledge

    Universal Activity Number

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

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

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

    ACPE PharmCon, Inc. 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.

 

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