4th PDA Europe Annual Meeting
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Individual Registration
Group Registration
Dear Colleagues,
We would like to invite you to join us when we welcome the European Medicines Agency to Amsterdam!
This year in exciting Amsterdam, the 4th European Annual Meeting promises to become another highlight in the 2019 PDA event calendar, featuring hot topics affecting the pharmaceutical industry as it is undergoing a true transformation.
Hear industry and regulatory agencies present their take on digitalization and automation of manufacturing processes, and benefit from best-practice-knowledge sharing on these and additional hot topics that truly affect the quality of medicines and the way forward!
We look forward to welcoming you to exciting Amsterdam this June!
Sincerely,
The 2019 Co-Chairs
Borke Van Belle,
Janssen J&J
Toni Manzano,
Bigfinite
Program Highlights
Regulatory Speakers Confirmed!
Hear updates from:
- European Medicines Agency
- US FDA
- WHO
- MHRA
- HPRA, PIC/S
Agenda
Discover What's Happening Each Day
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
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9:15 – 9:50 |
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9:50 – 13:15 |
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EU Regulatory Update Update on Current Product Quality Initiatives Building Regulatory Inspection Capacity and Promoting Good Regulatory Practice |
11:15 –11:45
Coffee Break, Poster Session & Exhibition
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Developments in the UK Medicines Regulatory Framework PIC/S: Vision, Reality, Aspirations Annex 1 and Regulatory Convergence Panel Discussion with Regulators & Industry |
13:15 –14:15
Lunch Break, Poster Session & Exhibition
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TRANSITION TO PARALLEL TRACKS |
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14:15 – 15:45 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 Skillset and Mindset Through DeepTraining in Virtual Reality Q&A, Discussion |
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14:15 – 15:45 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 Staying Ahead of the Curve in an Increasingly Complex Regulatory World Q&A, Discussion |
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14:15 – 15:45 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 PDA Update on the PUPSIT(SFQR) Initiative Q&A, Discussion |
15:45 –16:15
Coffee Break, Poster Session & Exhibition
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TRANSITION TO PARALLEL TRACKS |
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16:15 – 18:30 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 Q&A, Discussion |
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16:15 – 18:30 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 Future Challenges for Process Validation Q&A, Discussion |
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16:15 – 18:30 |
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LJ&J Labs Going Digital: iLABs Innovation User Case Study: The QC Lab of the Future Q&A, Discussion |
18:00
End of Day 1 and Networking Event
Wednesday, 26 June 2019
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TRANSITION TO PARALLEL TRACKS |
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9:00 – 10:15 Actions like the authenticity verification of returned drugs, the prevention of counterfeit drugs and medical devices or ensuring the consent traceability in clinical trials constitute examples of the blockchain capabilities in the Pharma industry. This technology is a powerful tool to guarantee transparency across complex transactions, but how much do you really know? |
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Blockchain: Beyond the Hype, Opportunities for Healthcare Blockchain Disruption in the Pharma World Q&A, Discussion |
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9:00 – 10:15 The right decisions require breaking boundaries between data silos. When the information has regulated sensitivity, data governance becomes a crucial quality task. Two pharma real-life examples describe different perspectives of quality data management and knowledge acquisition. |
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Data Management Between R&D and GMP Quality Analytics – How to Leverage Quality Data for QMS 2.0 Q&A, Discussion |
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9:00 – 10:15 The fragility of the VHP biodecontamination process has been recently aired and is a prominent topic for discussion. The concept and the benefits of a robotic tub pulsed light biodecontamination system as an alternative to existing surface biodecontamination processes is presented in this session. In addition, the aseptic control of components which have been surface biodecontaminated with VHP is presented. |
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Robotic Tub Decontamination System with Pulsed Light Maximizing Sterility Assurance by Utilizing Barrier Products and VHP Q&A, Discussion |
10:15 –10:45
Coffee Break, Poster Session & Exhibition
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TRANSITION TO PARALLEL TRACKS |
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10:45 – 12:30 AI is not a hype anymore in some industrial sectors but what is the real adoption status in the pharmaceutical industry? What actors are playing the AI roles when it comes to promoting and implementing it? Pharma, service providers, and academia will speak in this track about AI implementation into a regulated environment. |
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Real-time Data Analytics, AI and IoT in Pharmaceutical Manufacturing: Lessons Learned Leveraging Artificial Intelligence to Increase Patient Safety and Enable RTRT "Imagine If" through the Power of AI Q&A, Discussion |
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10:45 – 12:30 The right place for young talents: This session will provide motivated career starters an opportunity to practice their presentation skills and gain professional experience. Presenting on stage at a PDA conference may very well be the first step towards connecting with fellow peers and seniors in PDA, supporting career paths and enabling future collaborations. As this session is not assigned to a dedicated topic, the audience will benefit from fresh perspectives on a variety of exciting projects and interests. |
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Periodic Review of Validated Systems: Industry Review and Recommending a Best Practice Template Parenteral Packaging: CCS and CCI Quantifying Operator Subjectivity Within Flow Cytometry Data Analysis Modeling of the Freeze-Drying Process Q&A, Discussion |
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10:45 – 12:30 |
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Cell Therapy Manufacturing Process Controls GMP Requirements for Premises, Utilities, Equipment and Processes for ATMPs Production Ensuring Container Closure Integrity of Gene Therapy Products Needing Deep Cold Storage Q&A, Discussion |
12:30 –13:30
Lunch Break, Poster Session & Exhibition
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13:30 – 16:30 |
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Utilizing Data in the US FDA – A Case Study Leveraging Digital & Analytics to Drive the Next Horizon of Operational
Excellence |
14:30 –15:00
Coffee Break, Poster Session & Exhibition
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15:00 - 15:30 15:30 - 16:15 16:15 - 16:30 |
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Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
The iconic hotel, steeped in history and refinement, sits in the luxurious residential area of Amsterdam, a 10-minute walk from attractions like Rijksmuseum and Vondelpark. The elegant rooms - such as the famous John & Yoko Suite - provide the comfort you seek alongside amenities like the equipped Health Club. Explore fine Italian cuisine at Roberto’s or creative cocktails and a spacious garden terrace at Half Moon Lounge.
Hosting up to 700 guests in our 21 meeting areas, only 20 minutes from Schiphol and close to RAI Convention Center & World Trade Center, the hotel offers a private entrance, on-site parking and a marina backdrop.
PDA Europe has reserved a limited number of rooms until the 18th April 2019.
Book Your Room for the PDA Group Rate
Single Room € 256 per night*
Double Room € 277 per night*
- Buffet Breakfast in the restaurant
- Wireless Internet Connection (WI-FI)
- VAT, excluding 6% city tax
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
€1.895GovernmentMember Only
€850
Health AuthorityMember Only
€850
AcademicMember Only
€850
Non-Member
€2.195
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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