Toronto, Canada (PRWEB) January 09, 2013
Throughout the clinical development and commercialization lifecycle of products to treat rare diseases, there are a variety of clinical studies that can be conducted. Studies may be conducted for various reasons including product regulatory approval, patient access to a product for an unmet need, patient registries, or as a post-marketing requirement following product approval. The regulatory strategy employed often dictates the type of study that needs to be conducted to address an associated regulatory requirement.
Key Learning Objectives:
- US Regulatory requirements and associated study design - Registries, pre-, post-, and peri-approval designs
- EU regulatory environment and Compassionate Use/Expanded Access Programs (EAP)
- Real World case examples and lessons learned
For more information about this event or to register, visit: http://xtks.in/xto520
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Karen Lim (416) 977-6555 ext 227