Sponsorship for Regulatory Submissions and Changes $250.00 Three Available

Includes:

1 Admission

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.

• Stephanie Ranck, Sr Research Scientist, Global Regulatory Affairs-CMC Biotech/Insulins from Eli Lilly and Company, will be presenting Comparability Protocols, a Love/Hate Relationship
  

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.

• Linda Biava, Director of Regulatory Affairs, Regulatory Compliance Associates, Inc. will be presenting on Using Foreign Clinical Trial Data to Support a US Application not Conducted under an IND

The Food and Drug Administration (FDA) regulations permit the acceptance of foreign clinical studies, not conducted under an IND, in support of an application for marketing approval of a human drug, biological product, or device if certain conditions are met.  Under 21 CFR 312.120(c)(1), FDA will accept a foreign clinical study not conducted under an IND only if the study conforms to the ethical principles contained in the Declaration of Helsinki (Declaration), or with the laws and regulations of the country in which the research was conducted, whichever provides greater protection of the human subjects.  This presentation will provide details of the specific requirements that need to be met, what documentation can be used to support meeting these requirements, and possible scenarios on how to approach FDA to negotiate use of such clinical data to support a drug product application in the US. 

This dinner meeting will consist of a networking hour, dinner and presentations from our guests.