Sponsorship for Regulatory Submissions and Changes $250.00 Three Available
Table Top Display
2 Minute Podium Presentation about Company's Services/Products
PDA Midwest is delighted to present regulatory experts from Eli Lilly and Company and an additional speaker from Regulatory Compliance Associates, Inc. Each presenter will be providing examples of their challenges and strategies for global products.
The Comparability Protocol (US FDA) and Change Management Protocol (EMA) are reporting pathways for gaining prospective alignment on plans for CMC changes. It also allows proposal of a reduced reporting category to implement the change. This concept has been included in the draft ICH Q12 guideline. The advantages and disadvantages of utilizing this tool in the Regulatory toolbox will be discussed for multiple scenarios.
This dinner meeting will consist of a networking hour, dinner and presentations from our guests.