4th PDA Europe Annual Meeting

Amsterdam, The Netherlands
Ask a Question Exhibitor Standard Contract Clause
Program Highlights

Regulatory Speakers Confirmed!

Hear updates from:

  • European Medicines Agency
  • US FDA
  • WHO
  • MHRA

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!


The 2019 Co-Chairs

Borke Van Belle,
Janssen J&J

Toni Manzano,

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.


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.

Day 1

Tuesday, 25 June 2019

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


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


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

End of Day 1 and Networking Event

Day 2

Wednesday, 26 June 2019


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


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

Agenda is subject to change.

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.

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
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.