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Thursday
01:30am - 02:30am EDT - December 8, 2022
Gitte Bjørg Windfeldt, Head of Data Science, Digital Transformation & Technology, PSQIT TEC, Novo Nordisk A/S
Work-Life Balance - Presented by Women in Pharma™ | Join us for a roundtable discussion focused on Work-Life Balance where attendees can discuss experiences to encourage the development of relationships and the sharing of ideas and professional advice. The format will be interactive roundtable discussion style with questions and topics at each table.

Thursday
03:00am - 03:30am EDT - December 8, 2022
Mr. Stephen Wing, Head of Analytical & Logistical Services, Merck KGaA
Setting the Stage for eData Exchange |

Thursday
03:30am - 04:00am EDT - December 8, 2022
Mario Holl, Managing Director, InspectifAI GmbH
Revolutionizing Visual Inspection through Artificial Intelligence |

Thursday
04:00am - 04:30am EDT - December 8, 2022
Ádám Wolf, Engineer, Digital Laboratory, Takeda
Standardized Integration for Lab Robots |

Thursday
05:30am - 06:30am EDT - December 8, 2022
Mr. Mark Birse, Vice President Technical, Parexel; Roberto Conocchia, GMP Technical Lead, European Medicines Agency (EMA); Jean Francois Duliere, Reg Advisor, ISPE; Mr. Rick Friedman, Deputy Director, Office of Manufacturing Quality, FDA/CDER; Alan Moon, Lead Senior GMDP Inspector, MHRA; Mr. Rico Schulze, GMDP Inspector, Landesdirektion Sachsen
Regulatory Panel: Annex 1 Implementation | The updated Annex 1 has been released end of August, introducing changes which require more stringent sterile manufacturing processes, including implementing a contamination control strategy and new technology to reduce the risk of contamination. In this panel, Regulators will discuss those changes and how they impact our manufacturing practices and consider how Pharma 4.0ÿ concepts such as data management and clean room monitoring can assist with Annex 1 implementation. More work is now needed to bring clarification which could be needed in the future for a better implementation of this new document, training for all stakeholders and regulators will be needed to have an harmonized application of the new Annex 1.

Thursday
06:45am - 07:30am EDT - December 8, 2022
Mr. Rico Schulze, GMDP Inspector, Landesdirektion Sachsen
Reflection - Presented by ISPE Women in Pharma™ | Join us for a roundtable discussion focused on Reflection where attendees can discuss and reflect on their experiences to encourage the development of relationships and the sharing of ideas and professional advice. The format will be interactive roundtable discussion style with questions and topics at each table.

Thursday
07:30am - 08:00am EDT - December 8, 2022
Jeanne PREVOST, Student, University of Paris-Saclay; Cécilia Bourahla, Student, University of Paris-Saclay; Karen Abou Chakra, Student, University of Paris-Saclay; Estée Rignault, Student, University of Paris-Saclay
MIVAREP, an Innovative Percutaneous Valve: A Production Challenge for Pharmacy Students |

Thursday
08:00am - 08:30am EDT - December 8, 2022
Michael Dingle, Product Specialist, TSI, Inc.
Real Time Environmental Monitoring |

Thursday
08:30am - 09:00am EDT - December 8, 2022
Mr. Henrik Hegelund Louw, Strategy Specialist, Novo Nordisk A/S
A Step Towards Human-less Continuous Environmental Monitoring |

Thursday
09:30am - 10:00am EDT - December 8, 2022
Michael Dingle, Product Specialist, TSI, Inc.; Mr. Henrik Hegelund Louw, Strategy Specialist, Novo Nordisk A/S; Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
Panel Discussion on Continuous Environmental Monitoring |