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2009 PDA/EMEA Joint Conference: Ensuring Patient Safety through Supply Chain Control and GMP
Hotel Hilton Berlin
Mohrenstrasse 30, 10117
Berlin, Germany
2009 PDA/EMEA Joint Conference: Ensuring Patient Safety through Supply Chain Control and GMP

Schedule of Presentations:

Tuesday, October 13, 2009
07:00:00 Registration opens
07:45:00 New Member Breakfast (Invitation only)
07:50:00 Welcome and Conference Overview
09:00:00 Official welcome, background of the conference, goals, recognition of planning committee. Véronique Davoust
09:15:00 EMEA Perspectives Katrin Nodop
10:00:00 Setting the stage – Supply Chain, Manufacturing Quality & GMP in the Real World Gerald Heddell
10:05:00 Industry perspective on supply chain complexity and security issues Peter Boeken
10:15:00 Q&A
10:30:00 Coffee Break and Exhibition
11:00:00 Session 2 : Survey of current and pending European legislation and guidance on GMP and supply chain Véronique Davoust
11:15:00 Current legislation, guidance and related European initiatives Sabine Atzor
11:30:00 Current GMP and related guidance Katrin Nodop
11:35:00 The EudraGMP Database: Operational status and value to industry and regulators. Francisco Peñaranda
11:45:00 Q&A
12:00:00 Orientation to Parallel Tracks Véronique Davoust
12:45:00 How-to-be-a-PDA-Volunteer luncheon” (Open to conference attendees. Due to limited seating, please sign up at registration desk.)
12:45:00 Lunch Break
14:00:00 Parallel Tracks
14:05:00 Manufacturing and GMP, Room: Ballsaal B+C@
14:05:00 Suppl y Chain Qualit y ,Room: Ballsaal A~
14:05:00 Implementation of ICH Q8-9-10 , Room: Salon Corinth!
14:15:00 S1: Counterfeiting & Supply Chain: European Legislation ~ Andrew Bonser, Véronique Davoust, Sabine Atzor
15:00:00 Q1: Translating Design Space into CMC section of dossier and managing variations ! Elizabeth Coulson, Jean-Louis Robert, Liam Murphy
15:00:00 M1: Investigational Medicinal Products & GMP Annex 13 @ Bronwyn Phillips, Didier Hallard, Annie Rietveld
15:30:00 Exhibition and Coffee Break
16:15:00 Parallel Tracks continue
16:20:00 Q2: Risk Based Inspections - Planning & practice by Inspectorates! Tor Graberg, Thomas Barthel, Vjaceslavs Krauklis
16:20:00 M2: GMP Annex 2 and Challenges in Advanced Therapy Products@ Ian Rees, Annie Rietveld, Hiltrud Horn
16:20:00 S2: Product Life-Cycle management: sourcing, supply to outsourcing~ Isabelle Conrot, Paul Sexton
17:45:00 Adjourn for day
18:30:00 Networking Event (please meet in the Hotel Lobby)
19:00:00 Boat Trip including Dinner
Wednesday, October 14, 2009
06:45:00 Registration
07:00:00 Breakfast Sessions :
07:15:00 “Rx-360” and the Supply Chain Martin Van Trieste
07:15:00 Collaboration in Regulatory Guidance Development Stephan Rönninger
07:15:00 Collaboration in PDA Science & Technology Projects Jens Eilertsen
08:30:00 Parallel Tracks continue
08:30:00 Suppl y Chain Qualit y,Room: Ballsaal A~
08:35:00 Implementation of ICH Q8-9-10, Room: Salon Corinth !
08:35:00 Manufacturing and GMP , Room: Ballsaal B+C
09:00:00 Q3: QbD, QRM and Inspections ! Tesh Patel, Lina Ertle, Georges France
09:00:00 S3: Inspection of Importers and how they manage supply chain issues~ Esther Helfrich, Karl-Heinz Menges
09:00:00 M3: Dedicated facilities @ David Cockburn, Catherine Lefebvre, Stephen Brown
10:00:00 Exhibition and Coffee Break
10:45:00 Parallel Tracks continue
11:00:00 S4: Good distribution practice (GDP) Karl-Heinz Menges, Katrin Nodop, Michael P Dillon, Monika Derecque-Pois
11:00:00 Q4: Implications of Q10 for industry and inspectorate Lothar Hartmann, Jacques Morénas, Liam Murphy
11:00:00 M4: Current hot topics in GMP and Validation – Open discussion Thomas Barthel, Martyn Becker
12:15:00 Lunch
13:00:00 Closing Session: Putting the Pieces Back Together Katrin Nodop
13:30:00 Summary of Key Points and Issues from Parallel Tracks Véronique Davoust, Martyn Becker, Liam Murphy
13:35:00 Closing Remarks
14:00:00 Benefits of Risk Reduction and a PQS to the Bottom line – An Executive Management view Fabrizio Bonanni
14:00:00 Working Together for Enhanced International Cooperation Closing Panel, Q&A & Discussion David Cockburn, Bronwyn Phillips, Tor Graberg, Jean-Louis Robert, Fabrizio Bonanni, Stephan Rönninger
15:45:00 Conference Adjourns
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