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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
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
4 pda.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
6 pda.org/EU/Annual19
WORKSHOP AGENDA
18 Juni 2019
Monday, 24 June 2019 10:00 – 17:0010:00 Welcome and Introduction Falk Klar, PDA Europe
Martin Düblin, One One Eleven
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?
Martin Düblin, One One Eleven
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
7pda.org/EU/Annual19
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
8 pda.org/EU/Annual19
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
15:45 Coffee Break, Poster Session & Exhibition
9pda.org/EU/Annual19
CONFERENCE AGENDA
TUESDAY, 25 JUNE 201919:00 - 21:00
HILTON AMSTERDAM-GARDEN
LETS ROCK THEANNUAL
PARALLEL TRACKS
Session 3 TRACK A TRACK B TRACK C
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
17:15 Q&A, Discussion Q&A, Discussion Q&A, Discussion
18:00 End of Day 1 & Networking Event
CONFERENCE AGENDA
Live on Stage
Wednesday, 26 June 2019
PARALLEL TRACKS
Session 4 TRACK A TRACK B TRACK C
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
9:50 Q&A, Discussion Q&A, Discussion Q&A, Discussion
10:15 Coffee Break, Poster Session & Exhibition
CONFERENCE AGENDA
PARALLEL TRACKS
Session 5 TRACK A TRACK B TRACK C
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
12:15 Q&A, Discussion Q&A, Discussion Q&A, Discussion
12:30 Lunch Break, Poster Session & Exhibition
12 pda.org/EU/Annual19
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
14:30 Coffee Break, Poster Session & Exhibition
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 ‣
POST
ER S
ESSI
ON
TO CONFERENCE
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
14 pda.org/EU/Annual19
pda.org/EU/Annual2019 15
Extractables & Leachables
Both USP <1663> on extractables testing and the USP <1664> on leachables testing, as well as the recommendations of PQRI on inhalation applications (OINDP), parenteral applications (PDP) and ophthalmics (ODP) o� er a general framework for the design of both extractables and leachables studies. As these USP monographs and the PQRI documents are either informal or recommendations, it is the responsibility of the holder of the NDA to provide su� icient justifica-tions for the scientific approach that is taken in these projects.
Nelson Labs Europe can assist you in developing tailored protocols, specifically designed for your requirements or needs. Nelson Labs Europe has developed an extensive and detailed database - which contains over 5000 extractable compounds, built from authentic standards, for a fast and unique compound identification across three di� erent chromatographic platforms: • Headspace GC/MS • GC/MS • LC/MS (High Resolution Accurate Mass
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Nelson Labs is the leading global provider of laboratory testing and expert advisory services for MedTech and pharmaceutical companies.Based in Belgium, Nelson Labs Europe is a Center of Excellence providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries.
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Adv A4_Nelson Labs_20190617.indd 4 17/06/2019 11:14
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].
MEDIA PARTNERS
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!
To know more about the Sonnenhof Hospice, please visit www.bjoern-schulz-stiftung.de
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 817pda.org/EU/Annual19
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.
1 Registration
Your registration is only complete upon filling in and submitting both pages of this form.
Please mark here if your company is an exhibitor in this event and you will receive the conference ticket at the special price of 1195 € per ticket. No further discounts are applicable with this option (e.g. PDA Membership Discount or Group Ticket discount).
Discount for Exhibiting Companies
Group Registration Discount Register 3 colleagues for the conference at the same time and receive the 4th registration free. Other discounts cannot be applied. For more information on group discounts please contact at [email protected].
The fee includes event documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.
All fees given in Euro, excluding VAT (21%)
25-26 June 2019 Conference only Conference Fee
4th PDA Europe Annual Meeting PDA Member 1695
¹ Nonmember 1995
² Young Professionals 350
¹ Regulatory/Academic 850
Poster Presenter please mark here (written approval required, conference fee applies)
24 June 2019 Interest Group Meeting IG Meeting Fee
Quality Systems All Participants 350
24 June 2019 One-Day Workshop Workshop Fee
The Digital Robot Pharma Fab All Participants 795
Reg Form Page 1
24-26 June 2019 | Amsterdam | The Netherlands
¹Registration fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies).
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RESPONSE REQUIRED – By checking the box(es) below, I consent to: My contact information (name, company, job title, city, state, country) being printed on the attendee
list distributed at the event. PDA sending me promotional information via email.
PDA recording and/or photographing me and using those recordings and/or photographs in future PDA promotional and marketing materials.
PDA sending me promotional information via post
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.
This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.
18 pda.org/EU/Annual19
Date Mandatory Signature
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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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This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.
19pda.org/EU/Annual19
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