DC/Baltimore Area Chapter In Person Event: The Regulatory CMC Exchange Forum

In this full day workshop, attendees will share experiences and learnings on cutting edge CMC topics that will enable a deeper, practical understanding of each topic. The program will explore how industry peers and the FDA are approaching these new challenges.
The topics will include:

1) Use of accelerated predictive stability in development and regulatory filings
2) Platform manufacturing technology
3) Risk evaluation and control of nitrosamines
4) Biopharmaceutics –bridging expectations during drug product development and the use of in vitro and in silico methods as alternative paths to human in vivo testing

This highly interactive program will feature a CMC primer presentation on each of the four topics, followed by round-robin breakout sessions in which each participant has an opportunity to contribute to the discussion on each of the four specialty topics. Speakers and panelists for each topic will include experts from both FDA and industry. Each breakout will focus on a different aspect of CMC and will be led by 2 moderators, 2 industry experts, and 2 experts from the FDA.

A summary session will close the program as all four breakouts summarize the session and present insights, findings and recommendations. This program offers an excellent opportunity to address industry challenges and meet with FDA colleagues!

The meeting space is graciously hosted by Astra Zeneca. AstraZeneca (1 Medimmune Way Gaithersburg, MD 20878). Space is limited to early registration is encouraged. Registration fee includes lunch and refreshment break.

Registration Fees & Deadlines

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions