Real-World Data Collection in Early Access Programs: Opportunities, Challenges & Examples, Upcoming Webinar Hosted by Xtalks
TORONTO (PRWEB) August 20, 2019 -- There is a growing interest in pre-approval collection of real-world data (RWD) in early access programs, which manufacturers often set up for the provision of an investigational medicinal product to patients who are ineligible or otherwise cannot participate in the drug's clinical trials.
Early access programs are not research studies in the conventional sense, but regulatory bodies require adverse event reporting from these programs, and it is permissible to collect treatment outcomes, patient experience data and other real-world measures.
On Tuesday, September 24, 2019 at 10am EDT (3pm BST/UK), join featured speakers from Syneos Health including David Thompson, Senior Vice President Real World and Late Phase, Maryna Kolochavina, PharmD, PMP, Executive Director of Syneos One and Noolie Gregory, Executive Director of Client Engagement Real World Evidence, for this informative webinar. A Q&A session with the audience will follow the live presentation.
Attendees will gain insights into:
- Overview of early access programs
- Benefits and challenges of collecting real-world data and other real-world measures
- Regulatory requirements of early access programs
- Lessons learned from a case study
For more information or to register for this free event, visit Real-World Data Collection in Early Access Programs: Opportunities, Challenges & Examples.
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Candice Tang, Xtalks, http://www.xtalks.com, (416) 977-6555 227, [email protected]
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