LIU Logo

home   catalog   help   register   login

 Biosimilar Drugs: Legal, Regulatory & Safety Considerations

If you attended the live event and would like to receive credit please log in.

Type: Internet
Date(s): 10/10/19
Times: 6:00 PM - 8:00 PM ET
5:00 PM - 7:00 PM CT
4:00 PM - 6:00 PM MT
3:00 PM - 5:00 PM PT
Facility: RxSchool E-Classroom
  http://www.rxschool.com
Contact(s): RxSchool
1-866-960-5334
info@rxschool.com
Fee: $35.00


Course Category: This activity has been designated as Knowledge-Based

Using a Tablet or Smartphone?
Download the App for Apple, Android, or Blackberry
prior to the webinar for access on your device.


ACPE Live Credit
 Live CE Information


Target Audience:
Pharmacists
Pharmacy Technicians

Planning to Share a Computer During This Event?

Remember each person must register individually before the event. Once registered, please email info@rxschool.com and provide us with the names of the persons who will be sharing a computer for our ACPE records.

Course Overview:

Biologic agents are widely used to treat a variety of conditions. Biologic therapies include enzymes, vaccines, human insulins, interferons, human growth hormones, monoclonal antibodies, and tissue plasminogen activators. Patents for many of these agents will expire during the next few years and recent legislation has authorized the FDA to establish criteria for approval of biosimilar agents. Yet, there are important considerations for biosimilar agents that are quite different from generic chemical drugs. This course provides a background on biologic agents, information on the Biologics Price Competition and Innovation Act, and issues that pharmacies might consider as biosimilar agents come to market.

This course is approved by ACPE for 2 PHARMACY LAW credits hours.

Learning Objectives:
At the conclusion of this continuing education lesson, the pharmacist will be able to:

  • State the definition of a biologic agent and biosimilar product.
  • Explain how a biologic agent is manufactured.
  • Describe the difference between biosimilarity and bioequivalence.
  • List proposed regulatory criteria for FDA approval of biosimilar agents.
  • Discuss legislation and regulatory actions related to biosimilar agents.
At the conclusion of this continuing education lesson, the pharmacy technician will be able to:

  • State the definitions of a biologic agent and biosimilar product.
  • Explain how a biologic agent is manufactured.
  • Describe the difference between biosimilarity and bioequivalence.
  • List proposed regulatory criteria for FDA approval of biosimilar agents.
Faculty:
src=


Gina D. Moore, PharmD, MBA 

Director of Clinical Affairs, University of Colorado School of Pharmacy 

Gina Moore earned her PharmD degree from the University of the Pacific Thomas J. Long School of Pharmacy and Health Sciences in Stockton, California, and her Masters in Business Administration from the University of Colorado.
She began her career in Critical Care and Nutrition Support and completed a Nutrition Support Specialty Residency at University of Colorado. In 1995, Dr. Moore joined the Healthcare division of Thomson Reuters (at that time, Micromedex) first serving in an editorial capacity, then held various positions of increasing responsibility including Director of Product Management and Director of Clinical Solutions Support. At Thomson Reuters, she led several new product development teams and consulted with a variety of healthcare organizations across the country on decision support initiatives. 

Dr. Moore joined the faculty of the University of Colorado School of Pharmacy in 2008. She coordinates or teaches the law and management courses and is involved with an intraprofessional certificate program to certify healthcare professionals in health information technology.
Faculty Disclosure:
RxSchool has a Full and Fair Disclosure Policy that requires course faculty to communicate any real or apparent commercial affiliations related to the content of their presentations/materials.  There is no commercial support being used for this course. Participants are advised that the accredited status of RxSchool does not imply endorsement by the provider or ACPE of any products/therapeutics mentioned in this course. The information in the course is for educational purposes only.  

Gina Moore has nothing to disclose.

You must attend the entire webinar, participate in the interactive polling questions, and complete a post course evaluation in order to earn your CE credit.

 




 Courses Offered
 Biosimilar Drugs: Legal, Regulatory & Safety Considerations
Speakers:
Gina Moore, PharmD, MBA
 
Details:

Course Accreditation Information:



ACPE - Pharmacists Accreditation
Credit Hours: 2 Expiration Date: 08/23/2020 ACPE UAN: 0372-0000-17-038-L03-P    
  Release Date: 08/23/2017  

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

ACPE - Technicians Accreditation
Credit Hours: 2 Expiration Date: 08/23/2020 ACPE UAN: 0372-0000-17-038-L03-T    
  Release Date: 08/23/2017  

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



  System Requirements for E-Classroom
This is a live presentation delivered over the internet. In order to see and hear the program properly, you must have the following:

  1. Broadband internet connection, such as T1, Cable, or high-speed DSL.
  2. Before enrolling in this program, please test your internet connection here. It is important that you take this test on the same computer and network you will be using the day of the live presentation.
  3. One of the following internet browsers: Internet Explorer 7.0 or higher; Mozilla Firefox 3.0 or higher; Safari 1.1 or higher; Google Chrome
  4. Computer speakers or headphones connected to your computer.
  5. Adobe Flash Player. Click here for a free download of the latest version.
  6. Adobe Connect supports Windows, Mac OS, and Linux operating systems, but does not support Chrome OS at this time.
  7. If you are using a tablet or Smartphone, please download the Adobe Connect Mobile App for the device you are using prior to logging into the Live CE:
    • For Apple iPad or iPhone, click here to download.
    • For an Android tablet or Smartphone, click here to download.
    • For Blackberry devices, please click here to download.


    • (More information about the Adobe Connect Mobile App can be found here.)

The material presented here does not reflect the views of Pharmacy Choice, Inc., RxSchool, or the companies providing educational content. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.




Home | Help | Catalog | Register | Login


Powered By RxSchool

Copyright © 2000 - 2019 RxSchool - All rights reserved.