| Live Corporate Webinar : |
Monday : 17th December, 2012
02:00 PM EST | 11:00 AM PST
Click here for time zone conversion
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Orphan Drugs in Europe – How to use observational, real-world data to be successful
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| Presented by - Dr. William C. Maier, MPH, Ph.D, CSO & VP, Epidemiology & Risk Management, REGISTRAT-MAPI |
| Duration of webinar : 60 Mins | Duration of Q/A session : 10-15 mins |
| Deliverables : Copy of presentation slides will be shared |
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| Short
Abstract: |
About 30 million people living in the European Union (EU) suffer from a rare disease. In Europe a disease is considered rare when it has prevalence of 5 in 10,000 people. Treatments of rare diseases have long represented a huge unmet medical need for patients affected by them, as well as serious challenges for clinical development.
This presentation will cover the following areas :
- Orphan Designation; the COMP and criteria for orphan designation
- Incentives for orphan medicines in Europe.
- Challenges of clinical development for orphan drugs.
- Studies supporting marketing authorisation of orphan medicines.
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| Speaker Profile: |
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Dr William C. Maier, is Chief Scientific Officer and Vice President Epidemiology and Risk Management at Registrat-Mapi (www.registrat-mapi.com) the industry’s largest international clinical research organization (CRO) dedicated solely to “real-world” clinical research. Dr Maier has 25 years of experience in drug development and commercialization at pharmaceutical companies in Europe and the United States. He routinely provides guidance to pharmaceutical, biotechnology and medical products companies in Europe and the US on the development and approval of pharmacovigilance and risk management programs. In July 2007, he presented the Tysabri (Natalizumab) Risk Management Plan at both the EMA and FDA.more...
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