Tuesday, 25 June 2019
9:00
Welcome: Opening Remarks
Introduction & PDA Awards
Falk Klar, PDA Europe
Borke van Belle, Chair, Janssen J&J
Toni Manzano, Chair, Bigfinite
9:15 – 9:50
Keynote: Decision-Making Under Uncertainty
Felix Rebitschek, Max Planck Institute for Human Development
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9:50 – 13:15
Opening Plenary: Regulatory Updates - Current Situation
Moderator: Borke van Belle, Janssen J&J
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EU Regulatory Update
Brendan Cuddy, EMA
Update on Current Product Quality Initiatives
Tara Gooen, US FDA
Building Regulatory Inspection Capacity and Promoting Good Regulatory Practice
Alireza Khadem, WHO
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11:15 –11:45
Coffee Break, Poster Session & Exhibition
Developments in the UK Medicines Regulatory Framework
David Churchward, MHRA
PIC/S: Vision, Reality, Aspirations
Anne Hayes, HPRA on behalf of PIC/S
Annex 1 and Regulatory Convergence
Andrew Hopkins, AbbVie
Panel Discussion with Regulators & Industry
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13:15 –14:15
Lunch Break, Poster Session & Exhibition
TRANSITION TO PARALLEL TRACKS
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14:15 – 15:45
Session 2A: Virtual Reality
Moderator: Borke van Belle, Janssen J&J
This session will provide insights into virtual and augmented reality applications within the pharmaceutical manufacturing space:
What are practical applications, how do they deliver value, and how to scale?
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Improve Training and Service with Augmented Reality
Michael Pratz, Bausch + Ströbel Maschinenfabrik GmbH
Rene Zoelfl, Parametric Technology GmbH
Skillset and Mindset Through DeepTraining in Virtual Reality
Sebastian Scheler, Innerspace
Q&A, Discussion
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14:15 – 15:45
Session 2B: Managing Regulatory Requirements
Moderator: Barbara Allen, Eli Lilly
This session will explore the complexity of the global regulatory environment which continues to increase. Emerging technology and transformation in digitalization will drive further regulatory changes. Speakers and participants will share and discuss key challenges, solutions firms have developed to incorporate global requirements and ideas for alignment in the future.
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The Future of the Compliance Story
Stephan Roenninger, Amgen
Staying Ahead of the Curve in an Increasingly Complex Regulatory World
Henrik Friese,
Søren Thuesen Pedersen, Novo Nordisk
Q&A, Discussion
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14:15 – 15:45
Session 2C: Manufacturing Technologies
Moderator: Yves Mayeresse, GSK
This session will be oriented towards single-use-system application for improvement of manufacturing process and sterility.
By optimizing single-use technologies, investment and footprint can be decreased significantly while production capacity may increase.
The implementation of filters remains a technical challenge leading to an increase in process complexity.
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Low-Footprint, Intensified, Single-Use Platform for the Production of Viral Vaccines
José Castillo, Univercells
PDA Update on the PUPSIT(SFQR) Initiative
Maik Jornitz, G-CON Manufacturing
Q&A, Discussion
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15:45 –16:15
Coffee Break, Poster Session & Exhibition
TRANSITION TO PARALLEL TRACKS
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16:15 – 18:30
Session 3A: Robotics in Pharma
Moderator: Martin Düblin, One One Eleven
This session offers an introduction into the pharma business world where the focus areas are production and lab/analytics.
Robots and digital solutions get increasingly recognized as potential opportunities for Pharma applications, but not yet as much as they could be.
A complementary team of specialists will outline technologies which are available today, referencing installations from various projects and give a thorough overview of considerations to be aware of.
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The Factory of the Future: Robotics Applied to Life Science and Other Industries
Valerio di Giovanni, Altran
Ueli Schläpfer, Helbling Technik
Eric Gastel, Interlog Management
Robert Roennback, Ferring
Oskari Vinko, UniteLabs
Q&A, Discussion
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16:15 – 18:30
Session 3B: Implementing Technologies
Moderator: Barbara Allen, Eli Lilly
This session will discuss challenges that organizations face in scaling digital transformation efforts. A user case will illustrate how process validation lifecycle activities can be adapted to the new manufacturing reality composed of highly automated facilities, modular and mobile equipment and inline monitoring. Participants will hear about new approaches to AI and how to effectively scale technology throughout the business.
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Implementing Technologies in the Digital Space
Arne Zilian, Novartis
Future Challenges for Process Validation
Jürgen Funk, F. Hoffmann- La Roche
Q&A, Discussion
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16:15 – 18:30
Session 3C: Lab Space
Moderator: Patrick Costello, AbbVie
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LJ&J Labs Going Digital: iLABs
Carmen Verhoeven, J&J
Innovation User Case Study: The QC Lab of the Future
Lou Killian, Kneat Solutions
Q&A, Discussion
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18:00
End of Day 1 and Networking Event