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4th PDA Europe Annual Meeting

Jun 25 - Jun 26, 2019
Amsterdam, The Netherlands

Global Healthcare of the Present and the Future

  • Conference
  • Europe
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Program Highlights

Regulatory Speakers Confirmed!

Hear updates from:

  • European Medicines Agency
  • US FDA
  • WHO
  • MHRA
  • HPRA, PIC/S
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Overview

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

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Agenda

  • Day 1
  • Day 2

  • 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

    9:50 – 13:15
    Opening Plenary: Regulatory Updates - Current Situation
    Moderator: Borke van Belle, Janssen J&J

    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

    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

    13:15 –14:15
    Lunch Break, Poster Session & Exhibition

    TRANSITION TO PARALLEL TRACKS

    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?

    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

    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.

    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

    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.

    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

    15:45 –16:15
    Coffee Break, Poster Session & Exhibition

    TRANSITION TO PARALLEL TRACKS

    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.

    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

    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.

    Implementing Technologies in the Digital Space
    Arne Zilian, Novartis

    Future Challenges for Process Validation
    Jürgen Funk, F. Hoffmann- La Roche

    Q&A, Discussion

    16:15 – 18:30
    Session 3C: Lab Space
    Moderator: Patrick Costello, AbbVie

    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

    18:00
    End of Day 1 and Networking Event


  • Wednesday, 26 June 2019

    TRANSITION TO PARALLEL TRACKS

    9:00 – 10:15
    Session 4A: Blockchain Technology
    Moderator: Toni Manzano, Bigfinite

    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?

    Blockchain: Beyond the Hype, Opportunities for Healthcare
    Diede Ruelens, J&J

    Blockchain Disruption in the Pharma World
    Jordi Riulas, Capital Cell

    Q&A, Discussion

    9:00 – 10:15
    Session 4B: Beyond the Quality of Data

    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.

    Data Management Between R&D and GMP
    Helen Thomas, Janssen Vaccines

    Quality Analytics – How to Leverage Quality Data for QMS 2.0
    Markus Zeitz, Novartis

    Q&A, Discussion

    9:00 – 10:15
    Session 4C: Decontamination & Sterilization Technologies
    Moderator: Aidan Harrington, DPS Group

    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.

    Robotic Tub Decontamination System with Pulsed Light
    Anthony Hereng, Claranor
    Mirko Ebeling, EbeTech GmbH

    Maximizing Sterility Assurance by Utilizing Barrier Products and VHP
    Aaron Mertens, Steris

    Q&A, Discussion

    10:15 –10:45
    Coffee Break, Poster Session & Exhibition

    TRANSITION TO PARALLEL TRACKS

    10:45 – 12:30
    Session 5A: Artificial Intelligence in Pharma
    Moderator: Toni Manzano, Bigfinite

    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.

    Real-time Data Analytics, AI and IoT in Pharmaceutical Manufacturing: Lessons Learned
    Kasper Larsen, Novo Nordisk

    Leveraging Artificial Intelligence to Increase Patient Safety and Enable RTRT
    Sebastian Brandes, Criterion AI

    "Imagine If" through the Power of AI
    Marla Phillips, Xavier University

    Q&A, Discussion

    10:45 – 12:30
    Session 5B: Young Professionals in PDA
    Moderator: Falk Klar, PDA Europey

    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.

    Periodic Review of Validated Systems: Industry Review and Recommending a Best Practice Template
    Donncadh Nagle, Avara

    Parenteral Packaging: CCS and CCI
    Sarah Pelaez, LONZA

    Quantifying Operator Subjectivity Within Flow Cytometry Data Analysis
    Rebecca Grant, Loughborough University

    Modeling of the Freeze-Drying Process
    Bernadette Scutella, GSK

    Q&A, Discussion

    10:45 – 12:30
    Session 5C: Personalized & Precision Medicines
    Moderator: Patrick Costello, AbbVie

    Cell Therapy Manufacturing Process Controls
    Jon Petzing, Loughborough University

    GMP Requirements for Premises, Utilities, Equipment and Processes for ATMPs Production
    Maria Jesús Alonso Pérez, InterComBio

    Ensuring Container Closure Integrity of Gene Therapy Products Needing Deep Cold Storage
    Derek Duncan, LIGHTHOUSE

    Q&A, Discussion

    12:30 –13:30
    Lunch Break, Poster Session & Exhibition

    13:30 – 16:30
    Closing Plenary – What the Future Holds
    Moderator: Borke van Belle, Janssen J&J

    Utilizing Data in the US FDA – A Case Study
    Jennifer Maguire, & Alex Viehmann, US FDA

    Leveraging Digital & Analytics to Drive the Next Horizon of Operational Excellence
    Thibaut Dedeurwaerder, McKinsey & Company

    14:30 –15:00 
    Coffee Break, Poster Session & Exhibition

    15:00 - 15:30
    ICH Q12 Update - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
    Brian Dooley, EMA

    15:30 - 16:15
    Closing Panel Discussion with Regulators and Industry: Pathways to Implementing Innovation
    EMA, US FDA, Industry Representatives

    16:15 - 16:30
    Closing Remarks End of Conference
    Borke van Belle, Chair, Janssen J&J
    Toni Manzano, Chair, Bigfinite
    Falk Klar, PDA Europe

Highlighted Speakers

David M. Churchward
David M. Churchward
MHRA
Brendan Cuddy
Brendan Cuddy
European Medicines Agency (EMA)
CDR Tara Gooen Bizjak
CDR Tara Gooen Bizjak
U.S. FDA
Andrew D. Hopkins
Andrew D. Hopkins
AbbVie, Inc.
Sarah Pelaez
Sarah Pelaez
Ten23 Health
Marla Phillips
Marla Phillips
Xavier University
Bernadette Scutellà
Bernadette Scutellà
GSK
Carmen Verhoeven
Carmen Verhoeven
Johnson & Johnson
View All

Additional Information

  • Who Should Attend

    More information coming soon.

Got a Question? We have answers

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Travel

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.

Hilton Amsterdam

Apollolaan 138
Amsterdam, The Netherlands
Phone: +31(0) 20 7106000

Hilton Amsterdam
  • Accommodations

    Hotel Website

    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*

    *Rates are per room and night, including the following services and benefits
    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, excluding 6% city tax
  • Amenities

How to Get Here

By Air

Nearest Airport: Schiphol - AMS
Airport Phone: +31 20 794 0800

By Car

15 km, 20 min by car.

Take the A4 onto the A10 and exit at Amstelveen/S108. Turn right at traffic lights onto Amstelveenseweg. Turn right onto Stadionweg. Follow the Hilton signs onto Olympiaweg. Turn right onto Apollolaan. Turn left at 3rd traffic light.

The Hilton Amsterdam is at Apollolaan 138, Amsterdam, 1077 BG, Netherlands.

Other Options

Subway/ Rail: 5.00 EUR.

Taxi: 35.00 EUR.

Directions

Registration Fees

Early Registration
Registration Type Price by 28 April
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €750


Regular Registration
Registration Type Price after 28 April
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €850

All fees given in Euro and excluding VAT (21%)



Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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