Complimentary: Regulatory and Real World Evidence Challenges of Rare Diseases and Orphan Drugs
May 28 2014 11:00AM - May 28 2014 12:30PM | Online
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 will be broadcast in Eastern Time (ET)
Join us for this complimentary webinar!
- 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
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
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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.