PDA Midwest is delighted to present regulatory experts from Eli Lilly and and Company and an additonal 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.
Meeting Details and Agenda:
|Date:||March 15th 2018|
|Location:||Crowne Plaza Hotel|
|2875 Milwaukee Ave|
|Northbrook, IL 60062|
|Hotel Front Desk: +1 847 298 2525|
|5:00PM||Registration, Cocktails and Networking|
|7:00PM||1st Presentation: Comparability Protocols, a Love/Hate Relationship|
|7:45PM||2nd Presentation: Regulatory Submissions and Changes|
VEGETARIAN MEALS AVAILABLE - PLEASE INDICATE DURING REGISTRATION
|Event Date||03-15-2018 5:00 pm|
|Event End Date||03-15-2018 8:30 pm|
|Registration Start Date||01-01-2018|
|Cut off date||03-15-2018 11:55 pm|
|Location||Crowne Plaza, Northbrook IL|