Drug development for rare diseases and orphan drug areas have been increasing over the past 5 years due to an increase in health care spending on specialty care in the USA and other regions. In addition, the drug approval process is often shorter and there is a different process for approval of medications to treat these conditions.
This workshop will provide you with the knowledge to understand the process of drug approval for rare disease and orphan drugs in the USA and Europe, the tools to design and execute comparative effectiveness evaluations and other real world studies of product impact and examples of approved products and associated real world studies.
Pharmacovigilance, Epidemiology, Drug Safety, Risk Management, Regulatory or Product Leader Pharmaceutical companies or financial or investment institutions, or service providers as CROs, CMOs concerned with Biologics/Biotechnology/ Biogenerics, Biopharmaceuticals/ Biotherapeutics Head/VP/Director, Senior Managers of Commercial Affairs, Business Development, Marketing & Sales, Legal Affairs Pricing and Reimbursement, Health Economics, Intellectual Property. Clinical Trials New Product Development Quality Assurance/ Quality Control Anyone Interested in Clinical Trials
(Courtesy of Orphan Drugs for Rare Diseases, via newdrugapprovals.wordpress.com )
(For more information, please visit: http://www.biopractice.com)
Thursday, 12th September, 2013 (09:00 AM - 02:00 PM EDT)
NJHA Conference & Event Center, 760 Alexander Road, PO Box 1
Princeton, New Jersey
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