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.
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.
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.
Platinum Sponsorship for Sterility Assurance & Risk Mitigation. $1,000. One available
Includes:
Company's Name Highlighted at Lunch Buffet
2 Admissions
Table Top Display
2-3 Minute Podium Presentation about Company's Services/Products
Gold Sponsorship for Sterility Assurance & Risk Mitigation. $750. Three available
Includes:
Company's Name Highlighted at 1 Break
1 Admissions
Table Top Display
2-3 Minute Podium Presentation about Company's Services/Products
Silver Sponsorship for Sterility Assurance & Risk Mitigation. $500. Ten available.
Includes:
1 Admission
Table Top Display
Type | Price | Available place |
---|---|---|
Platinum Sponsor Platinum Sponsorship Package |
$1,000.00 | 1 |
Gold Sponsor Gold Sponsorship Package |
$750.00 | 2 |
Silver Sponsor Silver Sponsorship Package |
$500.00 | 3 |
A full day seminar for topics related to Microbiology and Microbial Contamination Control designed for microbiologists, technicians, quality managers and process engineers. Agenda will include 8 speakers from diverse industrial backgrounds representing the pharmaceutical and industrial microbiology industry with an exhibition of relevant industrial products. Breakfast, lunch and snacks will be provided.
Confirmed Presenters:
Join the PDA board members and their families at the Northwestern Medicine Field, the home of the Kane County Cougars, for a day packed with baseball, family entertainment, food, drinks, and much more. This is a relaxing and fun way to spend some quality time with family, friends and colleagues.
Pricing is free for PDA members and their families. Please register to confirm your ticket.
Date: 7/20/18 at 6:30 pm
Type | Price | Available place |
---|---|---|
Adults Adult Ticket |
$0.00 | 45 |
Children 3 -10 Children's Ticket |
$0.00 | 15 |