Denver, CO, USA
(Hyatt Regency Denver at the Colorado Convention Centre)
In response to the feedbacks from the pharma and biotech colleagues, GCC would like to build more channels of communications between Pharma and CROs including circulating surveys and conducting face-to-face meetings.
We would like to kick off the very first GCC/Pharma Scientific Interchange Meeting at this year's AAPS annual meeting in November in Denver. A meeting room has been booked on Nov. 13 Sunday afternoon (starting with a lunch, and finish before 5pm) at Hyatt Regency Denver at Colorado Convention Centre.
If you meet the inclusion criteria, you are then invited to participate in this Interchange meeting representing your company in bioanalysis to provide feedbacks and inputs on a few topics GCC has worked on this year including the below:
- FDA 483/Observation for not tabling data from failed runs in Validation;
- GCP Clinical Samples Bioanalysis;
- Extract stability;
- Electronic data management and integrity;
- Processed batch acceptance;
Surveys on each topic above will be circulated before the meeting, and survey results from Pharma will be compared to the CRO results and to be discussed at the face-to-face Interchange meeting.
Agenda of 1st GCC/Pharma Scientific Interchange Meeting
12:00pm-01:00pm : Buffet Lunch in Room Centennial G
01:00pm-01:15pm : Opening Remarks, Admonition Statement, and Participants' introduction
01:15pm-01:45pm : "FDA 483/Observation for not tabling data from failed runs in Validation"
01:45pm-02:15pm : "Extract stability"
02:15pm-02:45pm : "Processed batch acceptance"
02:45pm-03:30pm : Afternoon Break and Mixer Reception
03:30pm-04:00pm : "Electronic data management and integrity"
04:00pm-04:30pm : "GCP Clinical Samples Bioanalysis"
04:30pm Meeting Adjourn
Pharma/Biotech Inclusion Criteria:
- Presently working in the bioanalytical lab of a Pharma or Biotech;
- Holding a decision making position in bioanalytical sciences and regulations within the company (Executives, lab directors, lab managers or equivalent positions) to be able to represent your bioanalytical lab in your company;
- 1 representatives per Pharma or Biotech company (representing the small molecule bioanlayis due to the topics of the meeting
CRO Inclusion Criteria:
- Presently working in the bioanalytical lab of a CRO;
- Holding a decision making position in bioanalytical sciences and regulations within the company (Executives, lab directors, lab managers or equivalent positions) to be able to represent your bioanalytical lab in sciences and regulations in your CRO;
- 1 representatives per CRO company representing the small molecule bioanlayis due to the topics of the meeting
- Note: If you are an active GCC member who has participated in the April 18, 2016 GCC Closed Forum, you are automatically invited to this Interchange meeting however with the limitation of only one representative from your company.
If you meet the inclusion criteria, there will be no registration fee for attending the GCC/Pharma Scientific Interchange Meeting.
All you need to do is to inform us through an email to confirm your attendance. (There will be NO on-site registrations)
We look forward to seeing you in November in Denver.
Time:
The 1st GCC/Pharma Scientific Interchange Meeting will take place on Sunday November 13, 2016 during the AAPS Annual Meeting. It will be a Half Day Closed Forum starting at 12pm with lunch and finish before 5pm.
Location:
The 1st GCC/Pharma Scientific Interchange Meeting will be held at the AAPS headquarter hotel at the Hyatt Regency Denver at the Colorado Convention Centre - Centennial Ballroom F & G (650 15TH Street, Denver, Colorado 80202, USA).