pda.org/eu/annual19 4th pda europe annual meeting · toni manzano, phd, (mfnw 'nl*snyj borke...

pda.org/EU/Annual19

25-26 JUNE 2019AMSTERDAM, THE NETHERLANDSIG MEETING, WORKSHOP: 24 JUNE

EXHIBITION: 25-26 JUNE

Global Healthcare of the Present and the Future

4th PDA EuropeAnnual Meeting

https://pda.org/EU/Annual19

WELCOME FROM THE CHAIRS

Toni Manzano, PhD, Chair, Bigfinite

Borke van Belle, Chair, Janssen J&J

Dear Colleagues,

The 4th PDA Europe Annual Meeting is inviting you to Amsterdam, the new seat of the European Medicines Agency, to engage in presentations and discussions around “Global Healthcare of the Present and the Future”.

The pharmaceutical sector in general is undergoing a true transformation, in digitalization and automa-tion of the supply chain generally known as Industry 4.0, in fast expansion from traditional medicine to precision and personalized medicine.

The boundaries between diagnostics, devices and medicines are fading quickly, and competition is sup-plemented by non-traditional players.

New opportunities arise as connectivity to the patients through wearables and devices has become avail-able, and the patients’ conditions become a real-time reality.

Cutting-edge technology and scientific understanding enable development of breakthrough offerings to patients in prevention, interception, curing and managing conditions.

Our supply routes to the end-user have been revolutionized in this global space on one side, and challenged by regional and national interests which push localization, on the other side. In that global context, pharmaceutical players continue to experi-ence an increasing attention to sustainability.

What do these disruptions mean for development, supply chains, and patients?

What does the pharmaceutical regulatory framework of the future look like?

What is the impact on pharmaceutical manufacturing plants?

Plenty to discuss, plenty to learn, plenty to share!

Looking forward to seeing you in Amsterdam!

SCIENTIFIC PROGRAM PLANNING COMMITTEE

Borke van Belle, Chair, Janssen J&J

Toni Manzano, Chair, Bigfinite

Barbara Allen, Eli Lilly

Ursula Busse, Novartis

Patrick Costello, AbbVie

Martin Dueblin, One One Eleven

Aidan Harrington, DPS Group

Yves Mayeresse, GSK Vaccines

Falk Klar, PDA Europe

Sylvia Becker, PDA Europe, Senior Manager Programs & Events

2 pda.org/EU/Annual19


WELCOME TOAMSTERDAM

S C H E D U L E A T A G L A N C E

24 June 10:00 – 17:00 Quality Systems Interest Group Meeting

24 June 10:00 – 17:00 The Digital Robot Pharma Fab Workshop

25 June 9:00 – 18:00 4th PDA EU Annual Meeting Conference, Exhibition

25 June 19:00 – 21:00 Networking Event

26 June 9:00 – 16:30 4th PDA EU Annual Meeting Conference, Exhibition

For latest information, please visit: pda.org/EU/Annual19

Photo by Alfons Taekema on Unsplash 3pda.org/EU/Annual19



24 JUNE 2019, 10:00-17:00 – INTEREST GROUP MEETING

Welcome to the PDA Interest Group Quality Systems!

As usual for any PDA Interest Group, we come together once annually in a face-to-face meeting to discuss new and current items in our specialties.

Lothar Hartmann, Ph.D. Managing Director, Phact GmbH

Lothar Hartmann worked for Hoffmann-La Roche and Johnson & Johnson for more than 25 years before he became independent with ‘Phact’. Lothar served in numerous organizations such as APIC/CEFIC (Vice-Chair-man), EBEs (European Biopharmaceutical Enterprises) BioManufacturing Working Group (Chair) and PDA (“Board of Directors”, Quality Systems Interest Group Chair). Lothar is co- and lead-author of various docu-ments published by CEFIC/APIC and EBE, co-founder of PDAs “Paradigm Change in Manufacture” (PCMO; practical, hands-on application of ICH Q8 – Q11) and was part of the Expert Working Group of ICH Q7a. In this effort, he was FDA awarded in May 2004.

IG Leader

INTRODUCTION

10:00 Welcome Coffee All

10:30 Opening of the Meeting & Introduction of the IG QS EU Lothar Hartmann, Phact

KEY NOTE PRESENTATION

11:00 “Big Data”What does the future look like?

Toni Manzano, Bigfinite

SUB-GROUP’S FLOOR

11:45 Comparability of ICH Q10 with ISO 9000 Heribert Dahmen, Merck

12:15 CPV Agnès Hardy-Boyer, Sanofi-Pasteur

12:45 Lunch Break

SUB-GROUP’S FLOOR (contin’d)

13:30 Process Owner Sofia van Berlekom, AstraZeneca

14:00 Management Review Pia Sandau, Novo Nordisk

14:30

WORKSHOPS SESSION

Group 1:Does the PQS/QMS fit into the true lifecycle (ICH Q8 – 14)?

Lothar Hartmann, Phact

Group 2:What does a QMS look like in a digitalised world?

Jeremie Arrault, Novartis Michele Simone, Bracco

15:30 Coffee Break

PLENARY DISCUSSION

16:00 Presentation and Conclusions of the Discussions from the Workshops Moderator: Lothar Hartmann, Phact

17:00 End of IG Meeting



IG MEETINGQUALITY SYSTEMS

5pda.org/EU/Annual19


Workshop Leader

Martin Düblin, One One Eleven

Martin Düblin is a mechanical and process engineer and highly experienced in the field of the life science industry, infrastructure and health care community. For more than 25 years, he has been involved in many major strategic projects in Europe, North and South America, North Africa and Asia for laboratories, pilot scale installations, production, office buildings, hospitals, edu cation, warehouse, energy / utilities and waste management. Several products and brands have been launched under his responsibility. In his role as specialist for various life science companies, Martin has provided support in all kinds of technical «revolutions» such as full digital production with the help of robotics and AI, delivering high quality products, preparing the disruptive transition and ensuring global competitiveness.

In this one-day workshop, the world of Robots, Artificial Intelligence (AI) and overall digitalization will be presented. Drawing references from other industries, the potential for pharma applications will be demon-strated while introducing and transparently assessing risks and advantages. This includes a regulatory viewpoint.

The attendees shall receive insights into

• To what extent are these technologies feasible today and ready to be used?

• What is possible today with respect to pharma applications?

• Where are the limitations, if any, and what are they?

• What shall be considered when starting a project today?

The workshop includes lectures as well as hands-on training by mock ups and live activities presented in the exhibition hall. It serves as an introduction and includes some hands-on learning opportunities while focusing on personal exchange amongst all attendees and speakers. As the world continues to move and change fast, the aim is to offer a continuation of this workshop and present novel developments and solu-tions on an ongoing basis.

The Digital Robot Pharma Fab

PRE-CONFERENCE WORKSHOP

Workshop Overview



WORKSHOP AGENDA

18 Juni 2019

Monday, 24 June 2019 10:00 – 17:0010:00 Welcome and Introduction Falk Klar, PDA Europe


Robotics Martin Düblin, One One Eleven

The entire operations of a typical pharma fab will be grouped into the respective business areas: External logistics, warehouse, internal logistics, dispensing, compounding, filling, sterilizing, inspection, labelling, labs, infrastructure, QA, QC, FM, management, etc. The needs will be summarized and the potentials for implementing new technologies addressed.

10:30 Robot World• What do we have to understand about robots?• What capabilities do robots have today?• What are the next generations of robots?• How to get to a robust and reliable robot system?

Ueli Schläpfer, Helbling Technik

11:15 Coffee Break

11:45 Logistics• How does a traditional logistics organization operate today?• What alternatives are available already?• What might logistics look like in the near future?• In what way may a transition happen?

Eric Gastel, Interlog Management

12:30 Robots in Pharma Production• What are possible applications?• Where are robots already in use?• What are the benefits?• Do we just talk robot or is there more potential in using them?


13:15 Lunch Break & Exhibition There will be machinery and mock-ups presented in the exhibition area for gaining hands-on experience.

Manufacturing

Transitioning from today’s business into industry X.Y. Does this mean, there are robots at every possible position or is there more to it? There is a future under preparation which leads to a completely new world. Starting with the first business idea, executing a project, bringing it into operation, running the manufacturing, influencing all internal operational organizations, across the whole life cycle. What are the advantages of and with these future factories? What dimensions do we have to consider and what new business models are possible?

14:15 Future Manufacturing• Is it only continuous manufacturing?• Are there other manufacturing opportunities possible?• What does this mean to the Pharma business?• What might be the consequences at the longer end?

Robert Roennback, Ferring

15:30 Coffee Break & Interactive Hands-On Exhibition Continuation from Lunch Break

15:45 Lab Automation• Is automation only possible for manufacturing?• What solutions are available today?• What does the market consider and what developments have been started?• What might a lab look like in future?

Oskari Vinko, UniteLabs

16:15 Pharma Business Transition• In what way do robots, AI and full digitalization influence the business?• How do we have to prepare ourselves for the upcoming steps?• Are we ready to do so?• How might a typical pharma fab be organized and what does this mean

to the pharma business?

Valerio di Giovanni, Altran

17:00 Summary & Conclusion of Workshop Martin Düblin, One One Eleven

Possibility for Additional ExchangePlease feel free and use the opportunity to gain further hands-on experience with the installations in the exhibition area.

All participants



CONFERENCE AGENDA

Tuesday, 25 June 2019

9:00 Welcome: Opening RemarksIntroduction & PDA Awards

Falk Klar, PDA EuropeBorke van Belle, Chair, Janssen J&JToni Manzano, Chair, Bigfinite

Keynote: Decision-Making Under Uncertainty Felix Rebitschek, Max Planck Institute for Human Development

Opening Plenary: Regulatory Updates - Current Situation Moderators: Borke van Belle, Janssen J&JToni Manzano, Bigfinite

This session will provide the most recent regulatory updates. The political, technological, and scientific environment in which the pharmaceutical industry operates is changing rapidly. It is key to understand how the regulatory framework, initiatives and impulses keep the pace with these developments. This session also includes an opportunity to directly engage in a panel discussion with high profile regulators.

9:50 EU Regulatory Update Brendan Cuddy, European Medicines Agency

10:15 Update on Current Product Quality Initiatives Tara Gooen, US FDA

10:40 Building Regulatory Inspection Capacity and Promoting Good Regulatory Practice

Alireza Khadem, WHO

11:05 Coffee Break, Poster Session & Exhibition

11:35 Developments in the UK Medicines Regulatory Framework

David Churchward, MHRA

12:00 PIC/S: Vision, Reality, Aspirations Anne Hayes, HPRA on behalf of PIC/S

12:25 Annex 1 and Regulatory Convergence Andrew Hopkins, AbbVie

12:50 Panel Discussion with Regulators & Industry Representatives

Brendan Cuddy, EMAAlireza Khadem, WHOTara Gooen, US FDAAnne Hayes, HPRA on behalf of PIC/SDavid Churchward, MHRAAndrew Hopkins, AbbVie

13:15 Lunch Break, Poster Session & Exhibition



CONFERENCE AGENDA

TRANSITION TO PARALLEL TRACKS

PARALLEL TRACKS

Session 2 TRACK A TRACK B TRACK C

Topic Virtual Reality Managing Regulatory Requirements

Manufacturing Technologies

Moderator:Borke van Belle, Janssen J&J

Moderator:Barbara Allen, Eli Lilly

Moderator:Yves Mayeresse, GSK

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?

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.

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.

14:15 Improve Training and Service with Augmented Reality

Michael Pratz, Bausch + StroebelRene Zoelfl, Parametric Technology

The Future of the Compliance Story

Stephan Roenninger, Amgen

Low-Footprint, Intensified, Single-Use Platform for the Production of Viral Vaccines

José Castillo, Univercells

14:45 Cleanroom Skillset and Mindset Through DeepTraining in Virtual

Reality

Sebastian Scheler, Innerspace

Staying Ahead of the Curve in an Increasingly Complex

Regulatory World

Søren Thuesen Pedersen, Novo Nordisk

PDA Update on the PUPSIT (SFQR) Initiative

Maik Jornitz, G-CON Manufacturing

15:15 Q&A, Discussion Q&A, Discussion Q&A, Discussion




CONFERENCE AGENDA

TUESDAY, 25 JUNE 201919:00 - 21:00

HILTON AMSTERDAM-GARDEN

LETS ROCK THEANNUAL

PARALLEL TRACKS


Topic Robotics in Pharma Implementing Technologies Lab Space

Moderator:Martin Dueblin, One One Eleven

Moderator:Barbara Allen, Eli Lilly

Moderator:Patrick Costello, AbbVie

This session offers an introduction into the pharma

business world with focus areas 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 available today, referencing installations

from various projects and give a thorough overview of

considerations to be aware of.

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 (Artificial Intelligence) and how to effectively scale technology

throughout the business.

This session will outline the impact of digital transformation

in the laboratory. The laboratory should no longer

be identified as a testing hub simply releasing products.

A more holistic approach to digital transformation within

laboratories should allow information and data to flow

throughout the product lifecycle, informing decision making at each stage of development. The data created, managed

and interrogated appropriately can be a powerful implement

in driving process and product improvement.

16:15 The Factory of the Future: Robotics Applied to Life Science

and Other Industries

Process Validation in the Context of Industrie 4.0

Arne Zilian, Novartis

J&J Labs Going Digital: iLABs

Carmen Verhoeven, J&J

16:45 Valerio di Giovanni, AltranUeli Schläpfer, Helbling Technik

Markus Lanz, Interlog ManagementRobert Roennback, Ferring

Oskari Vinko, UniteLabs

Future Challenges for Process Validation

Jürgen Funk, F. Hoffmann - La Roche

Innovation User Case Study: The QC Lab of the Future

Lou Killian, Kneat Solutions


18:00 End of Day 1 & Networking Event

CONFERENCE AGENDA

Live on Stage

Wednesday, 26 June 2019

PARALLEL TRACKS


Topic Blockchain Technology Beyond the Quality of Data Decontamination & Sterilization Technologies

Moderator:Toni Manzano, Bigfinite

Moderator:Michele Simone, Bracco

Moderator:Aidan Harrington, DPS Group

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 we really know?

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.

The fragility of the VHP (vaporized hydrogen peroxide) bio-decontamination 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

processes is presented in this session. In addition, the aseptic control of components which

have been surface bio-decontaminated with VHP is

presented.

9:00 Blockchain:Beyond the Hype, Opportunities

for HealthcareDiede Ruelens, J&J

Data Management Between R&D and GMP

Helen Thomas, Janssen Vaccines

Robotic Tub Decontamination System with Pulsed LightAnthony Hereng, Claranor

Mirko Ebeling, EbeTech

9:25 Blockchain Disruption in the Pharma World

Jordi Riulas, Capital Cell

Quality Analytics – How to Leverage Quality Data

for QMS 2.0Markus Zeitz, Novartis

Maximizing Sterility Assurance by Utilizing Barrier Products

and VHPAaron Mertens, Steris



CONFERENCE AGENDA

PARALLEL TRACKS


Topic Artificial Intelligence in Pharma

Young Professionals in PDA Personalized & Precision Medicines

Moderator:Toni Manzano, Bigfinite

Moderator:Falk Klar, PDA Europe

Moderator:Patrick Costello, AbbVie

AI (Artificial Intelligence) 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.

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.

Advanced Therapy Medicinal Products have the ability

to significant ameliorate or cure disease and associated

symptoms. The science driving such products is fascinating

but the ability to manufacture these products is challenging.

This has resulted in a significant increase in regulatory guidance for manufacturing and quality

controls. This session will highlight current manufacturing,

testing and storage of such products.

10:45 Real-time Data Analytics, AI and Internet of Things in

Pharmaceutical Manufacturing: Lessons Learned

Kasper Larsen, Novo Nordisk

Periodic Review of Validated Systems: Industry Review

and Recommending a Best Practice Template

Donncadh Nagle, Avara

Update on GMP for ATMPs

Andrew Hopkins, AbbVie

11:15 Leveraging Artificial Intelligence to Increase Patient

Safety and Enable Real Time Release Testing

Sebastian Brandes, Criterion AI

Parenteral Packaging:Container Closure Safety and

Container Closure Integrity

Sarah Pelaez, LONZA

Cell Therapy Manufacturing Process Controls

Jon Petzing, Loughborough University

11:45 “Imagine If” through the Power of Artificial Intelligence

Marla Phillips, Xavier University

Quantifying Operator Subjectivity Within Flow Cytometry Data Analysis

Rebecca Grant, Loughborough University

Ensuring Container Closure Integrity of Gene Therapy

Products Needing Deep Cold Storage

Derek Duncan, LIGHTHOUSE

Modeling of the Freeze-Drying Process

Bernadette Scutella, GSK


12:30 Lunch Break, Poster Session & Exhibition



CONFERENCE AGENDA

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

This session will explore what is on the pharmaceutical horizon. Personalized and precision medicine, real-world patient data and Internet of Things pharmaceutical supply chains are only a few elements that will revolutionize our business, so how can the industry and the regulators jointly shape frameworks to enable progress and ensure patient safety?

13:30 Using Predictive Analytics to Drive Surveillance Decisions Jennifer Maguire & Alex Viehmann, US FDA

14:00 Leveraging Digital & Analytics to Drive the Next Horizon of Operational Excellence

Thibaut Dedeurwaerder, McKinsey & Company


15:00 ICH Q12 Update - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Brian Dooley, EMA

Panel Discussion: Pathways to Implementing Innovation Moderators: Borke van Belle, Janssen J&JBarbara Allen, Eli Lilly

16:30 Closing Remarks & End of Conference Borke van Belle, Chair, Janssen J&JToni Manzano, Chair, BigfiniteFalk Klar, PDA Europe

bioMérieux 18

Biopuremax 11

Brevetti C.E.A. 3

CAI 29

Charles River 13

COMECER 16

Datwyler 5

Elis Cleanroom 19

Getinge 15

Innerspace 23

InterLog Management 27

Kneat Solutions 1

LIGHTHOUSE Instruments 14

LONZA Cologne 4

Novatek International 21

PDA Chapter Table 25

PTI 17

Robotec Solutions 26

Rommelag 6

Sartorius Stedim 7

Smart Skin Technologies 9

SP Scientific 20

Steriline 8

Telstar 10

TSI 12

ValGenesis 30

WILCO 2

Floor PlanExhibit your Latest Technologies and Products

1817 19

16

26 27 28

29 30 31 32

13 14

15

9

10

11

12

2120

23

24 25

22

21 3

65 7

4

8

Track A-B-C

Orange Room

TO CONFERENCE ‣

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ON

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ENTRANCE

LOBBY

TO EXHIBITPDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-quali-fied, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibition and Sponsorship Oppor-tunities are available. A basic exhibition package for this event is priced 1.995€ net (table-top). For more information please contact [email protected]

Poster Session

Table Top

Catering

PDA Desk



pda.org/EU/Annual2019 15

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Inventive design is the best way to get an excellent result. This is why advanced engineering is the pillar of our process. We go beyond machine manufacturing: we focus on thedevelopment and production of performing solutions to provide tangible added value to customers looking for strong specificity combined to consistent quality. Our standard and robotic portfolio covers the following:

Washing and decontaminating Depyrogenating Filling, closing and capping Isolators

WE DON’T JUST FIND SOLUTIONS, WE ENGINEER THEM.

PERFORMING SOLUTIONS

STERILINE Srl - Via Tentorio 30 - 22100 Como - Italy

www.steriline.it |Booth 8

INFORMATION

VENUEHilton AmsterdamApollolaan 138 1077 BG Amsterdam Netherlands Tel: +31-20-7106000 https://goo.gl/EyXmhb

CONTACT INFORMATIONConference InquiriesMelanie DeckerDirector Events & [email protected] Program InquiriesSylvia [email protected] Customer CareTel: + 49 30 436 55 [email protected]/Sponsorship InquiriesChristopher [email protected] InquiriesMark [email protected]

GENERAL ADDRESSPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: + 49 30 436 55 08-0Fax: + 49 30 436 55 08-66

CONFERENCE REGISTRATION HOURSMonday, 24 June: 8:00 – 18:00Tuesday, 25 June: 8:00 – 17:00

SPECIAL REQUIREMENTSIf you require special accommodations to fully participate, please attach a written description of

your needs with your registration form. Specific questions can be directed to [email protected].

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CHARITY

DIRECTIONS

© Google For directions click on the picture, scan the QR-code or go to https://goo.gl/maps/HVtsNxUQ58E2

PDA Europe supports the children's hospice „Sonnenhof”

The Sonnenhof Hospice, located near PDA’s office in Berlin, offers support and assistance to families with children suffer-ing from incurable and/or debilitating diseases. At Sonnenhof, children, together with their families, can spend the time they have left as they wish and find some relief from their suffer-ing. Instead of purchasing expensive gifts for the conference speakers, PDA has decided to donate this amount to the Son-nenhof Hospice. You can also contribute and help us increase the amount, it is easy:

Buy a package of chewing gums at the registration desk. THANK YOU!

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Washing and decontaminating Depyrogenating Filling, closing and capping Isolators

WE DON’T JUST FIND SOLUTIONS, WE ENGINEER THEM.

PERFORMING SOLUTIONS

STERILINE Srl - Via Tentorio 30 - 22100 Como - Italy

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The Digital Robot Pharma Fab All Participants 795

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4th PDA Europe Annual Meeting

² Rate applicable to all professionals 30 years of age or younger. A proof via ID or Passport copy is required, please submit this via fax or e-mail. Rate does not include membership. Further discounts as of Early Bird and Group Discount are not applicable to this rate.

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Your registration is only complete upon filling in and submitting both pages of this form.

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3 WAYS TO REGISTER

Reg Form Page 2

24-26 June 2019 | Amsterdam | The Netherlands

If this form is an update to a previously submitted form, please check here.

I want to become a PDA Member.

4th PDA Europe Annual Meeting

2 Your Contact Information

3 Information about Visa Matters • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event

at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for

submitting documents by courier.) • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA

EU (together with their registration).

4 Payment Options

PDA Europe VAT I.D.: DE254459362

CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of up to € 100 excl. VAT per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 26 May 2019 you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaran-teed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or fax to +49 30 4365508-66.

online: pda.org/EU/Annual19FAX: + 49 30 436 55 08-66Email: [email protected]

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By Bank Transfer Beneficiary: PDA Europe gGmbHIBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBERBank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany

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American Express MasterCard VISAFor your credit card information safety:Please send your details by fax only (+49 30 4365508-66) or register online.

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This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.




2 0 1 9

24 June 24 June25-26 June

Workshop: The Digital Robot Pharma FabInterest Group Meeting Quality Systems4th PDA Europe Annual Meeting

Amsterdam, The Netherlands

2 September2 September3-4 September5 September

Interest Group Meeting Freeze DryingInterest Group Meeting Technology TransferBioManufacturingInterest Group Meeting Vaccines

Munich, Germany

2 September5 September

Interest Group Meeting Technology Transfer Project Management in the Pharmaceutical Industry Munich, Germany

24-25 September Pharmaceutical Freeze Drying Technology Berlin, Germany

24-25 September Particles in Injectables Berlin, Germany

21 October21 October21 October22-23 October

Workshops:Innovating the Journey from Manufacturing to the PatientInnovative Drug Delivery Systems/Combination ProductsImpact of Pre-fi lled Syringe Components on BiopharmaceuticalsThe Universe of Pre-fi lled Syringes and Injection Devices

Gothenburg, Sweden

12-13 November14 November

Pharma Logistics & Outsourced OperationsInterest Group Meeting Supply Chain Management Lisbon, Portugal

2 0 2 0

25-26 February Parenteral Packaging Basel, Switzerland

21-22 April Visual Inspection Forum Berlin, Germany

Subject to change For latest info: europe.pda.org Shortlist 18 Jun 2019

CONNECTINGPEOPLE SCIENCE AND

REGULATION®

europe.pda.org

GENERAL INFORMATIONPDA EUROPE GGMBHAM BORSIGTURM 60

13507 BERLIN, GERMANYTEL: +49 30 4365508-0

FAX: +49 30 [email protected]

P DA E U R O P E E V E N T S

pda.org/eu/annual19 4th pda europe annual meeting · toni manzano, phd, (mfnw 'nl*snyj borke...

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