Hi Members,
The third quarterly Regulatory Focus (RF) Article Series is here! In this RF Article Series, Orphan Drug Regulations: A Global Perspective, the Regulatory Affairs Professionals Society (RAPS) has tapped leading experts for their insight and experience on orphan drugs, those drugs designated for diseases that affect relatively few people, and for which there are little to no treatment options.
These regulatory experts from Australia, Canada, the EU and US examine and offer their predictions on the future of global orphan drug research, development and regulation. Articles discuss:
- new orphan drug programs in various parts of the world
- orphan drug designation variations
- processes for gaining orphan drug designation
- policy and legislation changes
- orphan drug research
- development incentives
- and more
Download the latest RF Article Series here
Mark your calendars: As part of the series, we will be hosting an "Ask Me Anything" session on Wednesday, 26 September, from 1:00 – 2:00 PM EST here on RegEx. Sharry Arora, Brenda Gryfe and Bridgette Kunst, three of the authors of the series, will be available to answer your questions in real time.
If you cannot make the session, please feel free to submit any questions ahead of time by replying to this discussion or sending me a private message.
Best,
Heather
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Heather Arkwright
Community Manager
RAPS
regex@raps.org------------------------------