IQ CMC Summit
Hot Topics in Pharmaceutical Innovation: Novel Modalities & Development Strategies
October 9, 2024
National Press Club, Washington, DC
** IN-PERSON ONLY **
Join us to explore CMC and regulatory aspects on various topics like artificial intelligence (AI)/machine learning (ML), data management, PFAS, Nitrosamine, MAPP, and novel modalities! The experts among our working group leads will present current CMC and regulatory perspectives and share challenges faced by your peers. If you have proposals, please reach out and we will form a track – bring your problems to us!
Through highlighted Working Group presentations, interactive Hot Topic Discussions led by each CMC Leadership Group, and breakout sessions attendees can expect to learn:
- Risk assessment and process to decipher these latest regulatory developments and challenges, and the roots of the challenge(s)
- Case studies, guidance, applications, and potential solutions presented by WG leads
- Learn ways to participate in cross-functional WGs to solve these problems
- The potential for future industry collaboration opportunities and/or concerted health authority engagement
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US Eastern Time Zone 8:00 AM – 8:55 AM 8:55 AM – 9:00 AM 9:00 AM – 9:40 AM
10:20 AM – 10:55 AM
1:00 PM – 1:35 PM
3:20 PM – 3:30 PM 3:30 PM – 4:40 PM
4:55 PM – 5:00 PM |
DRAFT PROGRAM AGENDA Continental Breakfast and Networking Welcome Industry Topic Keynote Address: Rising to the Challenge: In-Vitro Release of Long Acting Injectables Regulatory Topic Keynote Address: Allowable Content in Vials Content in Injectable Products (Vials) Hot Topic Discussion Nanomaterial and Nanotechnology WG Presentation (DPLG) Patient Centric Specifications and Bayesian Analysis in CMC Hot Topic Discussion (SLG) Networking & Lunch Next-Generation Data Analytics WG Presentation (ALG) IQ MLAC Update Artificial Intelligence, Machine Learning, and Automation Hot Topic Discussion Nitrosamines WG Presentation (DSLG) PFAS Hot Topic Discussion Break Parallel Breakout Sessions (Tentative Topics Below - # and Topics to be Decided by Participant Interest at Event) Debrief from Breakout Sessions Closing Remarks |
REGISTRATION
This event is open to the public. IQ membership is not required.
VENUE
National Press Club
529 14th St NW Washington, DC 20045