Agenda - US Pharmacopeial Convention

Prescription/Non-Prescription Stakeholder Forum
Meeting #6
October 21, 2014
USP Meetings Center
USP Headquarters, Rockville, Maryland
Agenda
8:30 a.m.
Registration and Information, Continental Breakfast
9:00 a.m.
1. Welcome and Opening
9:15 a.m.
2. USP Strategic Directions
Mario Sindaco/Chuck Bates, Chair
a. USP Strategic Planning and Initiatives (15 min)
b. Convention Resolutions (10 min)
c. USP Manufacturer Visit Overview and
Stakeholder Perspective (20 min)
d. Discussion (15 min)
10:15 a.m. 3. Publications Feedback
Emily Kaine
Joseph Moerke
Jon Clark/Chuck Bates
Chuck Bates, Moderator
Linda Guard
10:30 a.m. Break
11:00 a.m. 4. General Notices and OTC Project Team Activities
a. General Notices PT Update (15 min)
b. OTC Monograph Modernization PT Update (30 min)
Neil Schwarzwalder
John Punzi/Alan Potts/
Kylen Whitaker
i.
Prioritization, ID testing, and use of technology
c. Discussion (15 min)
12:00 p.m. Lunch
1:00 p.m.
5. Cycle Transition and CPI PT Directions
a.
b.
c.
d.
USP Outlook and Direction of PNP SF (10 min)
Ron Piervincenzi
USP Cycle Change Activity Overview (15 min)
Scott Kuzner
Success and Challenges in 2010-2015 Cycle (20 min)
Barbara Ferguson
Compendial Process Improvement PT Activities (45 min)
Phil Travis/Sue Beavis
i.
Update and Workplan Directions
ii.
Cycle Transition Process Proposals
e. Breakouts: Council of Experts Workplans/Addressing Challenges in the
2010-2015 Cycle/CPI PT Workplan (30 min)
All
3:00 p.m.
Break
3:30 p.m.
5. Cycle Transition and CPI PT Directions (continued)
f.
Breakout Reports and Discussion (45 min)
Breakout Leads
4:15 p.m.
6. Stakeholder Questions on Advance Briefing
Chuck Bates, Moderator
5:00 p.m.
Passing of the Gavel, Adjourn
USP Prescription/Non-Prescription Stakeholder Forum October 21, 2014, Rockville, Maryland
Chair rotation: PDA, CHPA, IPAC-RS, WCDG, CVG, AAPS, MWCDG, PhRMA, GPhA, NJPQCA, IPEC
Jessica Simpson