9th GCC Closed Forum for Bioanalysis at WRIB - April 13, 2015, Miami, FL, USA
Chair: Dr. Roger Hayes07:00am-08:00am
Breakfast and Registration
08:00am-08:15am
Opening Remarks, Admonition Statement, and Participants' introduction
08:15am-09:30am
" GMP/CMC influence in GLP/Regulated bioanalysis: Does CAPA have a place in regulated bioanalysis? Do we need to include method robustness? And if yes what to include? "
– Chaired by Mario Rocci and Isabelle Dumont09:30am-10:15am
"What are the best practices for supporting biosimilar studies. How should you quantify the innovator drug product? How do you handle multiple innovator formulations (e.g., US & EU sourced drug)? "
– Chaired by Rafiq Islam, Dominique Gouty and Chris Beaver10:15am-10:45am
Morning Refreshment Break
10:45am-12:15pm
"Status of method validation requirements in the preclinical space. Are we still being held to BE standards? Is FDA auditing preclinical BA specifically or just part of routine facility inspections? "
– Chaired by Richard LeLacheur, Elizabeth Groeber, Colin Pattison12:15pm-01:15pm
Buffet Lunch in Concerto Ballroom
01:15pm-02:15pm
"Best practices for measuring endogenous biomarkers beyond GCC recommendations on biomarkers. How do you measure down-regulated biomarkers; i.e., those endogenous substrates that upon treatment result in lower concentrations. How do you obtain matrix or are surrogate matrices the only way to go? How do you deal with selectivity and best practices for calculating percent analytical recovery or bias during method validation? "
– Chaired by Afshin Safavi, John Kamerud, and Laura Cojocaru02:15pm-03:15pm
"Whole blood stability/blood partitioning the subject of a recent directed FDA audit "
– Chaired by Stephanie Cape and Philippe Couerbe03:15pm-04:00pm
Wine and Cheese, and Ice Cream Break (of course also coffee and sweets)
04:00pm-05:00pm
" Regulatory Findings and "policy changes by 483 "
– Chaired by Roger Hayes and Mark Warren05:00pm
Meeting Adjourn and Welcome Reception of WRIB starts at 5:30pm at Rooftop Pool Deck of Hilton
Inclusion Criteria :
- Presently working in the bioanalysis field for a CRO;
- Holding a decision making position within the company (Executives, directors and laboratory managers or equivalent positions);
- Max 2 representatives for each CRO;
- More than 2 representatives could be accepted only if the CRO has multiple sites and/or involved in both small and large molecule bioanalysis.
Notes :
- All the participants will be invited to participate in the authorship of an influential document based on the conclusion of the closed forum.
- All the participants will be invited to contribute to the agenda of the closed forum.
- We keep the right to refuse multiple registrations from the same company if the closed forum reaches a too large size to guarantee adequate discussion.
How to become a member of the GCC?
If you meet the following criteria, you can then simply register to attend the next GCC Closed Forum representing your CRO company and contribute to the discussions during the GCC Closed Forum, as well as providing your inputs representing your company to the Paper (either White Paper or Conference Report) that concludes the discussions of the GCC Closed Forum.
Time and Location:
The 9th GCC Closed Forum will take place on Monday April 13, 2015, the day before the 9th WRIB (9th Workshop on Recent Issues in Bioanalysis) Main Workshop. It will be a Whole Day Closed Form starting at 8am and finishing at 5pm.
9th GCC will be held at the same venue of the 9th WRIB at the Hilton Miami Downtown (601 Biscayne Bouleverd, Miami, FL, USA 33132).
For hotel reservations, please use the WRIB hotel reservation link below: