• Home Study Details

  • Home / Learn / Home Study CE / Home Study Details


I Can't Wait That Long!: Access to Experimental Therapies

Program Type

Monograph

Credits

1 Contact Hour(s)

Release Date

Wednesday, January 27, 2021

Offline Date:

Thursday, July 27, 2023

ACPE Expiration Date

Saturday, January 27, 2024

Target Audience

Nurse, Pharmacist, Pharmacy Technician

Cost

$4.00

  • Overview

    Before a drug can be approved for marketing in the U.S. by the FDA, it must undergo testing to ensure that it is safe and efficacious. The approval is a slow and costly process, typically taking 8-12 years or more. However, seriously ill patients may not have the luxury of waiting for definitive regulatory approval, and disease activists have been advocating for faster availability of potentially life-saving therapies for decades. The FDA has responded with programs that speed up the approval process, create temporary approval, and expand access to treatments undergoing clinical trials. The recent pandemic has resulted in a resurfacing of questions and controversy regarding the speed and safety of investigational product approval and access. This lesson is designed to help pharmacists deal with these issues overall.

    Handouts

    Homestudy PDF:   21010H03.pdf

    Financial Support By

    PharmCon
  • Nurse

    Describe the drug approval process.
    Characterize and identify the legal and regulatory features of the FDA’s expanded access programs.
    Distinguish between compassionate use, emergency use authorization, and accelerated approval and how they apply to recent events.


    Pharmacist

    Describe the drug approval process.
    Characterize and identify the legal and regulatory features of the FDA’s expanded access programs.
    Distinguish between compassionate use, emergency use authorization, and accelerated approval and how they apply to recent events.


    Pharmacy Technician

    Describe the drug approval process.
    Characterize and identify the legal and regulatory features of the FDA’s expanded access programs.
    Distinguish between compassionate use, emergency use authorization, and accelerated approval and how they apply to recent events.

  • Activity Type

    Knowledge

    Universal Activity Number

    Nurse 0798-0000-21-010-H03-N

    Pharmacist 0798-0000-21-010-H03-P

    Pharmacy Technician 0798-0000-21-010-H03-T

    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
Adobe Acrobat Reader


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).

 

©2015 PharmCon All Rights Reserved | Terms & Conditions | Privacy PolicyContinuing Education For Healthcare Professionals
Developed By: ITB, Inc.