2023 PDA Robotics and Automation Conference

03 May - 04 May 2023
Amsterdam, The Netherlands

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Dear Colleague,

We are looking forward to welcoming you to the 2023 PDA Robotics and Automation Conference taking place on 03 - 04 May 2023 in Amsterdam, The Netherlands!

The criticality of the operations in drug manufacturing is explained by the specific dependency that patients require on the quality, safety, and efficiency of medicines. Recipes, processes, and tasks linked to the drug life cycle usually contain multiple manual actions led by operators that repeat similar tasks throughout the day, having differences depending on the product or the production phase. Robotization and automation in Pharma are intended to minimize the repetitive tasks performed by operators, including all those actions requiring human cognition in order to avoid undesired effects in the product. Complexity and variability are two aspects of the reality of drug manufacturing. Nothing is static, nothing is simple. When humans need to apply systematic actions in production, they must interact with equipment and material consequently to the specific task they are developing.

In Pharma, everything is connected and linked with the product and process, the robotization and automation transformation are the only solution to ensure full connectivity along the manufacturing chain and to have the right information at the right time. Understanding digital transformation as the mechanism that transforms manual actions into electronic data becomes essential for robotics and automation implementation and at the same time, the only way to generate value along the full process is to bring consistently the expected drug to patients under a performance configuration for the industry.

To make evolution possible, a change of mindset is needed. Working on the paper is not an option when a process must be optimized. Assigning repetitive tasks to operators when they could be performed by machines and computers in a more efficient and secure way is not the way to go. Delegating tasks to humans which can be better carried out by systems is not the expected strategy. Regardless of the economic margins, today we face problems of a global nature. Efficient processes, sustainable sites, distributed and subcontracted manufacturing, logistical complexity, and global distributors are examples of a configuration subjected to a complex network of parameters that is difficult to govern without digital help. Today it is necessary for companies to base their processes on the added value they provide from the biopharmaceutical knowledge of their processes and invest in those tasks related to this knowledge. 

The 3rd edition of the 2023 PDA Robotics and Automation Conference is designed to catalyze the transition for those biopharma organizations that are planning to be more competitive and efficient and to crystalize those drug manufacturing companies which are already implementing robotization and automatization systems with one main goal: improve the lives of patients.

Stay tuned!

Sincerely,

The Chairs
Dieter Bachmann, Janssen Johnson & Johnson
Toni Manzano, Aizon

SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • Dieter Bachmann, Johnson & Johnson 
  • Toni Manzano, Aizon 
  • Sesethu Dowiasch, Rockwell Automation
  • Yvonne Duckworth, CRB Group
  • Bernhard Gerl, Körber
  • Florian W. Huber, TissUse
  • David Hubmayr, Takeda
  • Timothy Hsu, AFDO/RAPS Healthcare Products Collaborative 
  • Marilyn Romieux, Merck
  • Philipp Schmid, CSEM
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Sabine Hartmann, Manager Programs & Events, PDA Europe
Note PDA is committed to deliver safe and secure in-person events. In conjunction with the venue and vendors supporting our event, PDA strictly adheres to all national, provincial and local government regulations. PDA is closely monitoring the situation and will continue to update this information if required.
Program Highlights

Look forward to the conference's highlight speaker Roberto Conocchia, EMA, Alejandro Rivera Rojas, UNIDO and Krishnakali Ghosh, US FDA.

The conference will take place at the Holiday Inn Amsterdam - Arena Towers!

Agenda

Discover What's Happening Each Day
Day 1 03 May Day 2 04 May
Wednesday, 3 May

Wednesday 03 May 2023

09:00

Welcome and Introduction
Falk Klar, PDA Europe
Dieter Bachmann, Janssen Johnson & Johnson
Toni Manzano, Aizon

Introducing the NEW Interest Group

09:25 - 11:05 I Opening Plenary: Regulatory Guidelines for Drug Manufacturing
Moderator: Dieter Bachmann, Johnson & Johnson

Pharmaceutical industry, and sterile injectables, is seeing tremendous changes. The development of different new classes of drugs and new forms of therapies as well as an increased demand for automation and digitalization leads to new innovative technologies. At the same time the regulatory framework is under review and changing significantly. The latest in a row of many updates comes with the new EU GMP Annex 1, which on one hand provides opportunity for new technologies to be established and at same time sets the stage for the next decade on regulatory expectations. This session will take a deeper look in these expectations and especially how this will translate for robotics, automation, and AI applications. Case studies will offer an opportunity to see advantageous integration into Contamination Control Strategy.

09:25 I EMA Approach to Support the Translation of Innovative Technologies
Roberto Conocchia, EMA

09:55 I Robotic and Automation: The Enabler for Higher Quality and Annex 1 CCS Compliance
Richard Denk, SKAN
Julian Petersen, Groninger

10:20 I Advances in Robotics and Open Interoperability Accelerates Innovation in Biopharm Manufacturing
Dr. Patrick Courtney, SiLa

10:45 I Q&A, Discussion

11:15 - 11:45 | Coffee Break, Poster Session & Exhibition

11:45 - 13:10 I Session 1: Digitalization in Manufacturing
Moderator: Marilyn Romieux, Merck

Digitalization in manufacturing spans many applications and can be implemented at many different levels. We will review how the holistic digitalization of Product Lifecycle Management (PLM) through fully integrated PLM digital tools allows to bring together the many processes, systems, organizations, users, and data involved in the lifecycle of a product, from its initial specifications to its disposal. We will then look at a specific use-case for digitalization in pharmaceutical manufacturing: the serialization of primary containers using radio-frequency identification (RFID) technology as an enabler for automation and improvement of several operations in Fill/Finish, allowing to limit human intervention, reduce risk and improve overall operational efficiency. Join us and take part in a discussion with our consultant and supplier speakers on the benefits of implementing digitalization solutions in manufacturing processes.

11:45 I Interactive Questionnaire

11:50 I Data Visibility and Traceability Throughout a Product Lifecycle
Adam Keyes, Kalypso - remote presentation - 

12:15 I Unit Level Syringe Identification as a Foundation for Industry 4.0 in the Fill/Finish and Beyond
Hervé Soukiassian, BD

12:40 I Q&A, Discussion

13:10 - 14:25 | Lunch Break, Poster Session & Exhibition

13:55 - 14:25 | Guided Poster Walk - Engage with our Poster Presenters in our Exhibition Hall

14:25 - 15:55 I Session 2: Digital Twins
Moderator: Timothy Hsu, AFDO/RAPS Healthcare Products Collaborative 

This session contains 2 approaches that are pushing forward to take advantage of blending together advanced data analytics, automation, and best practices to create (and use) digital/virtual twins. We will examine how the application of digital twins have broad impact in device modelling and engineering for development and product quality as well as how it has been used as a solution for pre-clinical testing. Our session will take you on a deep dive in methodology, advantages, best practices, and lessons learned in bringing these technologies and methodologies to multiple aspects of our industry.

14:25 I Interactive Questionnaire

14:35 I Data-Driven Process Optimization and Digital Twins: Harnessing Data from a Complex System to Drive Quality and Efficiency Gains
Anders Meister, cim.as
Roger de Reus, Novo Nordisk

15:00 I Towards a Digital Twin in Preclinical Trials - How Automation and Continuous Data Acquisition Enables AI-supported in Silico Models
Florian W. Huber, TissUse

15:25 I Q&A, Discussion

15:55 - 16:25 | Coffee Break, Poster Session & Exhibition

16:25 - 17:45 I Session 3: Virtual Reality and Augmented Reality
Moderator: Sesethu Dowiasch, Rockwell Automation

This session unpacks real-life use cases of how Extended Reality is applied within Global Manufacturing and Supply Chain. The presenters will go through the pain points that lead to the use cases, enabling technologies and the selection process for a vendor and technology provider. Additionally, some insights will be shared on the benefits of the of the solution, lessons learnt through the project lifecycle as well as possible roadmaps for the future regarding further automation and standardization of training and assessment.

16:25 I How is Takeda Exploiting the Benefits of Extended Reality in Global Manufacturing and Supply Chain?
Enxhi Gjini, Takeda

16:50 I Error Coverage and Error Detection Accuracy as Key Drivers for Automated Training in Virtual Reality
Sebastian Scheler, Innerspace

17:15 I Q&A, Discussion

17:45 | End of Conference Day 1 and Networking Event

Thursday, 4 May

Thursday, 04 May 2023

09:00 - 10:25 I Session 4: Sustainability
Moderator: Yvonne Duckworth, CRB Group

The session on Sustainability will be kicked off by UNIDO, the United Nations Industrial Development Organization (UNIDO) which is a specialized agency of the United Nations that assists countries in economic and industrial development. This presentation provides an overview of UNIDO´s Health Industry Framework including essential medicines, vaccines, medical equipment, and diagnostics, followed by how they will break down the way innovation & technologies can promote sustainable growth. The next presentation will focus on the impact of considering the full life cycle of a product for a holistically sustainable solution for products and businesses, how this is currently being enabled, and how others can do the same.

09:00 I Advancing Sustainability in Health Industry: UNIDO Approaches and Experiences 
Alejandro Rivera-Rojas, UNIDO

09:30 I Environmentally Conscious Design 
Bernhard Gerl, Körber

09:55 I Q&A, Discussion

10:25 - 10:55 | Coffee Break, Poster Session & Exhibition

10:55 - 12:20 I Session 5: Artificial Intelligence
Moderator: David Hubmayr, Takeda

The session on Artificial Intelligence is kicked off by hearing about opportunities for applied modeling to maximize use of data and drive explicit knowledge generation and sharing as well as lowering the barrier to use models with fit for purpose tools as part of end-to-end Model Factory. Following an Outline and Art of the Possible as well as a discussion on typical challenges companies face when contemplating Technology-enabled Post Market Quality Transformations will be presented. Pragmatic solutions and illustrative case studies, enabled by advanced Artificial Intelligence and Machine Learning (AI/ML) technologies, with tangible benefits, will be shared.

10:55 I Interactive Questionnaire

11:00 I Driving a Culture of Explicit Knowledge Generation in BioTherapeutics Development - One Byte at a Time
Steve Mehrman, Janssen

11:25 I A Pragmatic Approach to AI-Enabled Complaints Transformation
Salil Thakar, Pricewaterhouse Coopers

11:50 I Q&A, Discussion

12:20 - 13:20 | Coffee Break, Poster Session & Exhibition

13:20 - 16:45 I Closing Plenary: Digital Transformation Journey in GMP Environment
Moderator: Toni Manzano, Aizon

Digitization has made it possible to drive automation and robotics towards the concept of smart manufacturing. It thus becomes the value-added mechanism throughout the entire manufacturing process to consistently deliver the expected drug to patients with the industry's current performance settings. This session will delve into some regulatory aspects around the role of digitization in GMP contexts.

13:20 I Interactive Questionnaire

13:30 I Process Validation: Revised PDA Technical Report 60 and Links with Artificial Intelligence Applications
Mauro Giusti, Eli Lilly

13:55 I Accelerating Digital Transformation Securely by Ensuring Data Integrity
Sesethu Dowiasch, Rockwell Automation

14:20 - 14:50 | Coffee Break, Poster Session & Exhibition
14:50 - 14:55 | Passport Raffle 

14:55 I Digital Transformation and Path to Regulatory Compliance
Krishna Ghosh, US FDA - remote presentation - 

15:25 I Achieving Data Integrity and Governance Amidst Pharma's Digital Revolution
Scott Deckebach, Lachman Consultant Services, Inc. 

15:50 I Q&A, Final Panel Discussion

  • Krishnakali Ghosh, US FDA
  • Mauro Giusti, Eli Lilly
  • Scott Deckebach, Lachman Consultant Services
  • Salil Thakar, Pricewaterhouse Coopers
  • Sebastian Scheler, Innerspace
  • Yvonne Duckworth, CRB Group

16:30 I Chairs Conference Summary
Dieter Bachmann, Johnson & Johnson
Toni Manzano, Aizon

16:40 I Closing Remarks & Farewell
Falk Klar, PDA Europe

16:45 End of Conference

Agenda is subject to change without notice.

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Location and Travel

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.


Holiday Inn Express: Amsterdam - Arena Towers
Hoogoorddreef 66b
Amsterdam, The Netherlands

Make a Reservation

PDA recommends the reservation at the following hotel

Holiday Inn Amsterdam - Arena Towers
Hoogoorddreef 66b
1101 BE Amsterdam-Zuidoost
Netherlands
Tel: +31-20-7979198

Book your room at the PDA Group Rate via the above-mentioned reservation button.

Holiday Inn Express: Amsterdam - Arena Towers
Hoogoorddreef 66b
1101 BE Amsterdam-Zuidoost
Netherlands 
Tel: +31-20-7979193

PDA Europe has reserved a limited number of rooms by 15 March 2023.


Holiday Inn and Holiday Inn Express Amsterdam Arena Towers are located in the bustling Amsterdam Southeast.

How to Get Here
By Air You will get to the hotel by car within 20 minutes from Airport Schiphol.
By Car We offer 440 parking areas at the hotel. Costs for parking is € 25,00 per night, or € 3,00 per hour (max € 25,00 per night). Drive to the barrier, where you can take your ticket and drive onto the parking lot (not covered). Navigation: Haaksbergweg 3.

Registration

Pricing Options

Standard Registration

Member Price

€2.045

GovernmentMember Only

€970

Health AuthorityMember Only

€970

Early Career ProfessionalMember Only

€970

AcademicMember Only

€970

Non-Member

€2.345

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

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 registration-europe@pda.org 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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Christopher Haertig

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Christopher Haertig

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