Annual NCRAF Roundtable Dinner
Date and Time
Thursday Nov 7, 2019
5:30 PM - 8:00 PM EST
Networking Reception 5:30-6:30
Buffet Dinner and Roundtable Discussions 6:30-8:00 pm
Location
The Friday Center
100 Friday Center Dr.
Chapel Hill, NC 27517
Fees/Admission
Register here
Attention Students, Post-Docs, and unemployed jobseekers! If you are not an NCRAF member, you may apply the discount code "NCRAF2019" to receive $15 off the registration fee! (yes, we're all on the honor system). If you are already an NCRAF member, please do not use this code as your registration is already discounted to $30.
Contact Information
Lauren Neighbours
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Description
The Roundtable Dinner will feature a networking reception with complimentary bar, followed by buffet dinner with seating at multiple tables, each featuring a speaker who will lead the dinner discussion on a different topic. Each table therefore will be a unique opportunity to learn about and discuss a topic of your choosing with a local expert in the topic, in a small-group setting (5-10 persons/table).
- Table 1: It Takes a Village to Author a Briefing Document: Working with Cross-Functional Teams to Author Pre-IND and EOP2 Briefing Documents
- Table 2: Benefit vs. Risk: Expedited Development of Therapeutics for Serious and Life-Threatening Diseases
- Table 3: From Benchtop to Desktop: Transitioning into Regulatory Writing
- Table 4: Artificial Intelligence in Medical Devices
- Table 5: Global Approach to Software as a Medical Device (SaMD)
- Table 6: Advanced Therapies - Scientific Progress, Regulatory Requirements and Ethical Implications
- Table 7: Health Canada Process after the Letter of Authorization is Received
- Table 8: MDR/IVDR Update
- Table 9: The Benefits and Risks of Transitioning from Full Time Employee to Independent Contracting/Consulting
- Table 10: Quality from an RA Perspective
- Table 11: Navigating Drug Development Under the Animal Rule (21 CFR 314.600-650)
- Table 12: How to Benefit from the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD)
- Table 13: Creating Effective Data Visualizations for Regulatory Submissions
- Table 14: Stem Cell Therapies
- Table 15: Mind the Gap(s): Early Identification of Issues is Key for a Successful NDA or BLA
