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Complimentary: Regulatory and Real World Evidence Challenges of Rare Diseases and Orphan Drugs

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Overview 



This Solution Provider Webinar is brought to you by DIA in cooperation with Optum.


Therapeutics for rare diseases face unique challenges in addressing regulatory and market access requirements around the world.  This webinar will provide an overview of the European, US and Canadian landscapes for these products. Our speakers will share their experience from the regulatory, market access and commercial perspectives. 


This webinar is available for order until May 31, 2015
Duration:  1 hour 28 minutes

Featured Topics 

  • The Regulatory perspective: Patricia Anderson, Optum
  • The Market access perspective: Karl Gregor, Optum
  • The Commercial perspective: Mike Cloutier, InterMune Canada Inc.

Who Should Attend 

Professionals who work in the area of:

  • Regulatory affairs
  • Marketing and commercialization
  • Market access and pricing
  • Health policy and reimbursement
  • Health economics and outcomes research

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Describe the current challenges facing life sciences companies with orphan drugs in development
  • Compare regional differences in requirements for achieving orphan drug designation, approval and reimbursement
  • Contrast value assessment considerations by HTA bodies and payers
  • Identify solutions to address the unique regulatory, payer and commercial challenges for orphan drugs

Special Offers 

Registration for a Solution Provider Webinar is FREE! Sign up by clicking on the Register Online button.

Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Archived Webinar Details
Jessica Culp
DIA North America
Phone +1.215.442.6132
Fax +1.215.442.6199
Jessica.Culp@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Thursday, May 29, 2014

  • 7:00AM - 11:59PM

    Complimentary: Regulatory and Real World Evidence Challenges of Rare Diseases and Orphan Drugs

    Speaker(s):

    • The Regulatory Perspective: Orphan Designation
      Patricia R Anderson, RAC
      Vice President, Regulatory Services
      Optum, Canada
    • The Commercial Perspective: Rare Disease, Not So Rare Access Issues
      Mike Cloutier
      President and General Manager
      InterMune Canada, Inc., Canada
    • The Market Access Perspective: Orphan Drug Value Assessment
      Karl Gregor, PharmD, MS
      Vice President, Product Value Strategy Consulting
      Optum, United States

Registration Fees 

Other Fees

Complimentary
$0.00
Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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