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2nd PDA Europe Annual Meeting

Jun 13 - Jun 14, 2017
Berlin, Germany

  • Conference
  • Europe
Program Highlights

PDA proudly announces the Key Note Presentation: ‘The Political Landscape and the Future of the Pharmaceutical Industry’

By Martin Lush: Global Vice President NSF Health

When you read the newspapers, listen to the radio or watch the TV news, do you take a sharp intake of breath and ask yourself: Brexit – Trump – what next?

In this world of uncertainty the following facts are undeniable:

  • We will all be impacted. No one will be immune
  • The frequency of these high impact events will increase. They are here to stay
  • You can’t prepare for each and every one. You can have the plan of all plans and still fail
  • Being ‘average’ is no longer good enough. Only the exceptional companies will prosper by doing the basics exceptionally well

PDAs core mission is to not just to put science first but to link the science with the real world. Martin’s key note session will do just that. It will set the scene for the rest of conference and beyond. He will cover:

  • The challenges that are here to stay
  • What ‘basics’ our industry must do exceptionally well to prosper in a world of brutal disruption and uncertainty
  • Everyone will go away with a set of rules and tools they can apply immediately

In preparation for this session Martin has asked for the views and opinions of over 1,000 industry experts from across the world. Don’t miss it!


After the tremendous success of the first PDA Europe Annual Meeting, we look forward to the second edition of this conference in Berlin, Germany, 13 – 14 June. The main theme of this 2nd PDA Europe Annual Meeting is Global Healthcare of the Present & the Future, building a bridge between current demands in the global healthcare industry, big data issues as well as promising personalized medicine and medicinal products. The meeting will also include presentations from regulatory, industry and technology representatives from around the world. Get a comprehensive insight into manufacturing of parenterals, learn about new developments, current demands and get involved in discussions with experts. A continually changing regulatory environment poses a variety of challenges the pharmaceutical industry needs to tackle. Inspection trends will be reviewed from different angles, the regulator and industry perspectives.

Looking into the future, the meeting will highlight the understanding of modern engineering and how it can change the pharmaceutical world. Furthermore, the meeting addresses topics like the impact of Industry 4.0 on pharmaceutical manufacturing processes: in particular Human Factors, Connectivity and Handling and Management of Big Data. We look forward to seeing you in Berlin.


  • Scientific Planning Committee

    Stephan Rönninger, Amgen, Co-Chair
    Véronique Davoust, Pfizer, Co-Chair
    Ivo Backx, Siemens
    Borke van Belle, Janssen J&J
    Mario Bott, Fraunhofer IPA
    Tor Graberg, AstraZeneca
    Maik Jornitz, G-CON Manufacturing
    Toni Manzano, BigFinite
    Yves Mayeresse, GlaxoSmithKline
    Mike Morris, Ext. HPRA
    Chris Procyshyn, Vanrx Pharmasystems
    Ryan Smith, Sight Machine
    Falk Klar, PDA Europe
    Georg Roessling, PDA Europe

    Tuesday, 13 June 2017

    Welcome: Opening Remarks

    Falk Klar, PDA Europe
    Stephan Roenninger, Amgen, Co-Chair
    Veronique Davoust,Pfizer, Co-Chair

    Keynote: Current Political Landscape and the Future of Our Industry
    NSF Health Sciences

    Opening Plenary: CURRENT DEMANDS

    Moderator: Stephan Roenninger, Amgen

    International Regulations of Pharmaceuticals in the Future

    GMP Harmonisation - Challenges and Opportunities
    MHRA / PIC/S

    Medical Products & Regulatory System in Iran

    Coffee Break, Poster Session & Exhibition

    Challenges in Vaccines Development and Manufacturing

    Q&A, Discussion

    Lunch Break, Poster Session & Exhibition


    Session 1


    Moderator: Yves Mayeresse, GSK

    Engineering has always been an applied science, improving technology to deliver cost effective and optimal solutions. New factories and old are built and retrofitted to become more flexible in all of the operations involved. Different tools are available and can be activated to achieve this goal: new operational models, single-use systems, continuous processing and modular approaches. A comparison of different cleanroom designs with the associated benefits and drawbacks will be presented in this session. The world becomes increasingly digital, and also in manufacturing, all the processes along the life-cycle need to become more interconnected. Digital simulation and modelling of any future project helps evaluate the potential for improvement. Feasibility studies, through commissioning, plant management and even maintenance and service need to be made interdependent. Integration allows not only an increase in efficiency, but also a reduction in cost and improvement in overall process and product quality. All these topics will be discussed in detail during this session.

    Comparison of Cleanroom Designs & Structures – Cost and Benefit Review
    G-CON Manufacturing

    Flexibility by Design – Flexibility and Innovation in Facility Design for Manufacturing of Tomorrow’s Vital Biopharmaceutical Products

    From Integrated Engineering to Integrated Operation

    Q&A, Discussion

    Coffee Break, Poster Session & Exhibition


    Moderator: Borke Van Belle, Janssen J&J

    The human factor in relation to pharmaceutical products deserves an end-to-end focus. Providing solutions for patients and healthcare workers requires full understanding of the user-to-product interface, the patient's condition and application conditions. This information and insight needs to be built into the product during Research and Development. On the other hand, Good Manufacturing Practices and regulatory expectations applying to supply and distribution chains safeguard the companies and patients through a number of preventive requirements and corrective controls to manage potential impact of the human factor. In this session, we will focus on this end-to-end view, and learn how the patient as ultimate customer is centric in understanding the human factor as being key for the success of a pharmaceutical product.

    User Centered Design: Exploring Physical Capabilities of Intended Users

    The Patient Perspective
    Cambridge Design Partnership

    How Mixed Reality will Drive the Future of Drug Delivery Product Development

    Q&A, Discussion

    Coffee Break, Poster Session & Exhibition

    Session 2


    Moderator: Stephan Roenninger, Amgen

    Quality requirements in the supply chain are increasing in an effort to prevent counterfeits and drug shortages. This session will focus on and provide an insight on how risk of drug shortages can be addressed and what manufacturers can do. A tool for managing single and multi-source challenges for drug availability will provide a practical example on how manufacturers and/or Marketing Authorization holders but also wholesalers can manage continued supply. Finally, we will receive an overview on current expectations on the distribution of medicines, highlighting pitfalls from an inspector's point of view.

    Reducing Risk of Drug Products Shortages

    Managing Single- and Multi-Source Supply Chain Challenges: A Practical Tool
    Genentech / Roche

    Experience with GDP Inspections

    Q&A, Discussion

    End of Day 1 & Networking Event


    Moderator: Tor Graberg, AstraZeneca

    Is there any contradiction between quality and cost? Or is it simply the way that lack of quality will immediately increase the cost? This potential dilemma will be scrutinized in conjunction with the importance of Quality Culture both from an industry perspective as well as the view of regulators. Attendees will gain an understanding of the importance to facilitate quality in combination with cost awareness as well as the paramount need for a clear Quality Culture.

    Total Cost of Quality: Speaking Business Language
    Janssen J&J

    Developing a Culture of Quality

    Are Quality Costs Fully Calculable? A GMP-Inspector's View
    District Government of Upper Bavaria

    Q&A, Discussion

    End of Day 1 & Networking Event

    Wednesday, 14 June 2017

    Session 3


    Moderator: Christopher Procyshyn, Vanrx

    With the increased focus on advanced processes, the limits of traditional environmental monitoring methods are being stretched. Experts from a range of companies will provide insight into their experiences with new monitoring technologies, as well as the practical implementation of these technologies into new automated, closed aseptic processes. Attendees will gain an understanding of the regulatory implications and a view to the future.

    Continuous Microbiological Monitoring for Aseptic Manufacturing

    New Advanced Aseptic Filling Technology in a New Greenfield Manufacturing Facility
    DPS Engineering

    Repeatable H₂O₂ Measurement during Bio-Decontamination: Measurement Technology, Relative Humidity vs. Relative Saturation and Material Selections

    Q&A, Discussion

    Coffee Break, Poster Session & Exhibition


    Moderator: Toni Manzano, Bigfinite

    Do we know the real implication of the digital transformation in the industry? Industrial Internet of Things or Machine to Machine are terms that begin to sound familiar in pharma and that are a reality in the health, automotive and energy sectors. When the cloud concept is added to these ingredients, new concerns arise. The industrial digitalization obviously requires innovative technology, but also a new mindset able to advance people into a new generation driven by connectivity: the era where existing knowledge becomes part of production.

    Driving Digital Transformation: Best Practices for Realizing Value from New Technology within your Organization
    Sight Machine

    NDigital Transformation Systems in Healthcare

    Internet of Things for Predictive Analytics
    Ghent University

    Q&A, Discussion

    Coffee Break, Poster Session & Exhibition

    Session 4


    Moderator: Mike Morris, exHPRA

    Modular and Scalable Facility Design to Meet Manufacturing Requirements for Modern Therapeutic Approaches
    Charité Berlin

    Process Design – Migration to a Modelling Based Workflow
    DPS Engineering

    Risk-based Tools for Designating Appropriate Room Classification for Biopharmaceutical Operations in Conceptual Design
    Novo Nordisk

    Lunch Break, Poster Session & Exhibition


    Moderator: Ryan Smith, Sight Machine

    Big Data, Internet of Things, Machine Learning, Artificial Intelligence: How to Transform Pharma Manufacturing & Biotech Processes

    From Bits to Bedside: Developing a Learning Digital Health System to Evaluate Pigmented Skin Lesions
    University of California, San Francisco

    Discovering Novel Biomarkers by Robotic Molecular Diagnosis

    Lunch Break, Poster Session & Exhibition


    Moderator: Véronique Davoust, Pfizer

    Light and Life: How Spectroscopy Supports the Life Sciences
    Leibniz Institute of Photonic Technology

    Reimbursement and Cost of Quality
    BeyondSpring Pharma

    Panel Discussion
    Committee Members and Speakers

    Quo Vadis, Pharma Industry?

      • Disease Management
      • Insurance, Coverage
      • Mobile Solutions from Diagnosis to Treatment
      • Paradigm Shifts: Interconnect R&D, Industry, Patient
      • Globalized Medicine: Drug Affordability, Availability

    Summary, Conclusions Closing Remarks End of Conference & Farewell
    Falk Klar, PDA Europe

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

Got a Question? We have answers

Contact Us


PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hilton Berlin

Mohrenstrasse 30
Berlin, Germany


Hilton Berlin
Mohrenstraße 30
10117 Berlin
Hotel Website

Hilton Berlin is a 5-star hotel offering a sun terrace, a winter garden and a library. Featuring traditional architecture, the hotel has been open since 1990.
It is located close to the Berlin Cathedral, the Reichstag Dom and the city center, just 1km from the Potsdamer Platz subway station. The hotel is within walking distance  of Pergamon Museum, the Concert House Berlin and the shopping malls of Friedrichstraße.

This stylish hotel comprises rooms like Leisure Dome Suite, Hilton Deluxe Hilton Guest Room and Hilton Dome Guest Room with contemporary decor and such comforts as an in-room safe, a minibar, TV, a living space and a CD player. Many rooms come with a captivating view of the cathedral. The airy rooms feature bathrooms with a bathtub, a bidet and free toiletries.

The dining options include a deluxe buffet breakfast served daily. Guests can enjoy exquisite flavors of German meals at the lounge restaurant. The cozy lobby bar features live music, a terrace and free Wi-Fi.

PDA Europe has reserved a limited number of rooms until the 30th April 2017.

Book your room for the PDA Group Rate.

Single Room € 189 per night
Double Room € 209 per night

This hotel provides a shuttle service.

How to Get There

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 6091 1150
Hotel distance: 11.9 km. About 24 to 40 min

  • Bus, Subway service, fee: € 2.7 (one way)
  • Estimated taxi fare: € 25 (one way)

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 6091 1150
Hotel distance: 25.2 km. About 30 to 50 min

  • Bus & Subway service, fee: € 3.5 (one way)
  • Estimated taxi fare: € 40 (one way)


On-site parking fee, inquire at the hotel desk


How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.


Registration Fees

Regular Price

4 Ways to register

  • Online Registration
  • FAX: +49 30 436 55 08 66
  • [email protected]
  • Mail: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • 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).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?


By 16 April 2017
1,395 Euro

After 16 April 2017
1.595 Euro


By 16 April 2017
1.695 Euro

After 16 April 2017
1.895 Euro

Govern./Health Authority/Academic

By 16 April 2017
700 Euro

After 16 April 2017
800 Euro

All fees given in Euro and excluding VAT (7%)


Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.


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