Conference Schedule

Tuesday, 11 June 2013

07.00 – 08.00	Continental Breakfast
08.20 – 08.30	Welcome, Opening Remarks Nancy Berg, CEO & President, ISPE
08.30 – 09.30	Plenary Presentation: Quality Risk Management Jaspreet Gill, Vice President, Global Quality and Compliance, Baxter
09.30 – 10.30	Plenary Presentation: Quality Pays for Itself Andy Skibo, Regional Vice President, Biologics-Supply, MedImmune/AstraZeneca
10.30 – 11.00	Networking Break
11.00 – 13.00	Breakout Sessions: Basic PAI Readiness Success and Advent of Breakthrough Therapies Session Moderator: Joe Famulare, Genentech, Inc. Quality Management of CMOs Session Moderators: Mike Arnold, Pfizer, Inc. and Mike Smedley, Acting Director, OMPQ, FDA Leadership in Pharma Quality Management Session Moderator: Edwin Rivera-Martinez, U.S. Quality Liaison, Global Quality, Sanofi-Aventis
12.00 – 18.30	Exhibit Hall Open
13.00 – 14.00	Lunch
14.00 – 15.00	Plenary Presentation: Supply of Medicines to the EU Gerald Heddell, Director, Inspection Enforcement and Standards, MHRA
15.00 – 15.15	Networking Break
15.15 – 17.00	Industry-Led Hot Topic Discussion Forum Session Moderator: Joe Famulare, Vice President, Genentech, Inc. Speakers: Andy Skibo, Carol Bye, Invited, Brian Lange and John Pinion
17.00 – 18.30	Networking Reception in Exhibit Hall

07.30 – 15.30	Exhibit Hall Open
08.00 – 09.00	Continental Breakfast
09.00 – 09.45	ISPE Drug Shortage Survey Results Francois Sallans, Johnson & Johnson
09.45 – 10.30	Consequences of Drug Shortages Valerie Jensen, Associate Director for Drug Shortage, CDER, FDA
10.30 – 11.30	Networking Break
11.30 – 12.30	Drug Shortage Panel Discussion Facilitator: Joe Famulare, Vice President, Genentech, Inc. Panel Members: Steve Mahoney, Zena Kaufman, Sam Venugopal, Val Jensen, Francois Sallans
12.30 – 13.30	Lunch
13.30 – 15.30	Breakout Sessions: Quality Metrics Session Moderator: Cindy Salamon, Bristol-Myers Squibb and Russ Westyk, FDA, Invited Controlling Pharma Data in the Cloud Session Moderators: Randy Perez ,PhD, Director, Information Governance and Management, Novartis and Krishna Ghosh, Compliance Officer- CDER/ Office of Compliance, FDA
15.30 – 16.00	Networking Break
16.00 – 17.00	Plenary Presentation: Vision for Quality Howard Sklamberg, Director, Office of Compliance, FDA

07.30 – 09.30	Breakfast with the Regulators Moderator: Steve Lynn, Senior Advisor to the Assistant Commissioner for Operations Office of Regulatory Affairs/Office of Operations Immediate Office, FDA Speakers: Ernie Bizjak, Compliance Officer, DHHS/FDA/ORA/OGROP Brooke Higgins,Pre-Approval Manager/Investigator, DHHS/FDA/ORA/OGROP Carmelo Rosa, Director, DIDQ, FDA
09.30 – 10.30	Plenary Presentation: Leadership's Role in the Culture of Quality John Pinion, Senior Vice President, Quality and Compliance, Genentech, Inc.
10.30 – 11.00	Networking Break
11.00 – 13.00	Breakout Sessions Process Performance and Product Quality Monitoring System Session Moderator: George Millili, PhD., Merck & Co., Inc. CAPA and Lifecycle QRM Session Moderator: Steve Tyler, AbbVie Continually Investing in Your Facilities and Equipment Session Moderator: Tim Howard, Commissioning Agents, Inc.
13.00 – 14.00	Lunch
14.00 – 16.00	Meet the Press Session Moderators: Jeff Salkin, Host Direct Connect, Maryland Public Television Bill Paulson, Editor-in-Chief, IPQ Panel Members: Cindy Salamon, Vice President, Global Quality Services, Bristol-Myers Squibb Rick Friedman, Associate Director for Risk Science Intelligence & Prioritization, OMPQ,FDA Joe Famulare, Vice President, Genentech, Inc. Ilisa Bernstein, Deputy Director, Office of Compliance, CDER, FDA Gerald Heddell, Director, Inspection Enforcement & Standards Division, MHRA
16.00 – 16.30	Closing Remarks