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Parenteral Drug Association Connecting People, Science and Regulation ®

2nd PDA Europe Annual Meeting

Jun 13 - Jun 14, 2017 |
Jun 14, 2017 |
Hilton Berlin | Berlin, Germany
  • Conference
  • Europe
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Speaker Biographies

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.

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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

9:00
Welcome: Opening Remarks

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

9:15
Keynote: Current Political Landscape and the Future of Our Industry
NSF Health Sciences

Opening Plenary: CURRENT DEMANDS

Moderator: Stephan Roenninger, Amgen

9:45
International Regulations of Pharmaceuticals in the Future
WHO

10:15
GMP Harmonisation - Challenges and Opportunities
MHRA / PIC/S

10:45
Medical Products & Regulatory System in Iran
IFDA

11:15
Coffee Break, Poster Session & Exhibition

11:45
Challenges in Vaccines Development and Manufacturing
Takeda

12:15
Q&A, Discussion

12:45
Lunch Break, Poster Session & Exhibition

TRANSITION TO PARALLEL TRACKS

Session 1

Track A: TRENDS IN MODERN ENGINEERING

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.

13:45
Comparison of Cleanroom Designs & Structures – Cost and Benefit Review
G-CON Manufacturing

14:15
Flexibility by Design – Flexibility and Innovation in Facility Design for Manufacturing of Tomorrow’s Vital Biopharmaceutical Products
NNE

14:45
From Integrated Engineering to Integrated Operation
Siemens

15:15
Q&A, Discussion

15:45
Coffee Break, Poster Session & Exhibition

Track B: HUMAN FACTORS

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.

13:45
User Centered Design: Exploring Physical Capabilities of Intended Users
Novartis

14:15
The Patient Perspective
Cambridge Design Partnership

14:45
How Mixed Reality will Drive the Future of Drug Delivery Product Development
Worrell

15:15
Q&A, Discussion

15:45
Coffee Break, Poster Session & Exhibition


Session 2

Track A: SECURING THE SUPPLY CHAIN

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.

16:15
Reducing Risk of Drug Products Shortages
GSK

16:45
Managing Single- and Multi-Source Supply Chain Challenges: A Practical Tool
Genentech / Roche

17:15
Experience with GDP Inspections
MHRA

17:45
Q&A, Discussion

18:15
End of Day 1 & Networking Event

Track B: MANAGING THE QUALITY-COST DILEMMA

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.

16:15
Total Cost of Quality: Speaking Business Language
Janssen J&J

16:45
Developing a Culture of Quality
AstraZeneca

17:15
Are Quality Costs Fully Calculable? A GMP-Inspector's View
District Government of Upper Bavaria

17:45
Q&A, Discussion

18:15
End of Day 1 & Networking Event

Wednesday, 14 June 2017

Session 3

Track A: ADVANCED ASEPTIC PROCESSING & ENVIRONMENTAL MONITORING

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.

9:00
Continuous Microbiological Monitoring for Aseptic Manufacturing
Pfizer

9:30
New Advanced Aseptic Filling Technology in a New Greenfield Manufacturing Facility
DPS Engineering

10:00
Repeatable H₂O₂ Measurement during Bio-Decontamination: Measurement Technology, Relative Humidity vs. Relative Saturation and Material Selections
Vaisala

10:30
Q&A, Discussion

11:00
Coffee Break, Poster Session & Exhibition

Track B: CONNECTIVITY, SMART DEVICES & ANALYTICS

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.

9:00
Driving Digital Transformation: Best Practices for Realizing Value from New Technology within your Organization
Sight Machine

9:30
NDigital Transformation Systems in Healthcare
Altran

10:00
Internet of Things for Predictive Analytics
Ghent University

10:30
Q&A, Discussion

11:00
Coffee Break, Poster Session & Exhibition

Session 4

Track A: FACILITY DESIGN & MODELLING

Moderator: Mike Morris, exHPRA

11:30
Modular and Scalable Facility Design to Meet Manufacturing Requirements for Modern Therapeutic Approaches
Charité Berlin

12:00
Process Design – Migration to a Modelling Based Workflow
DPS Engineering

12:30
Risk-based Tools for Designating Appropriate Room Classification for Biopharmaceutical Operations in Conceptual Design
Novo Nordisk

13:00
Lunch Break, Poster Session & Exhibition

Track B: CONNECTIVITY, HANDLING BIG DATA & DATA MANAGEMENT

Moderator: Ryan Smith, Sight Machine

11:30
Big Data, Internet of Things, Machine Learning, Artificial Intelligence: How to Transform Pharma Manufacturing & Biotech Processes
Bigfinite

12:00
From Bits to Bedside: Developing a Learning Digital Health System to Evaluate Pigmented Skin Lesions
University of California, San Francisco

12:30
Discovering Novel Biomarkers by Robotic Molecular Diagnosis
DRIVER

13:00
Lunch Break, Poster Session & Exhibition


Closing Plenary: TECHNOLOGIES & PHARMA OF THE FUTURE

Moderator: Véronique Davoust, Pfizer

14:00
Light and Life: How Spectroscopy Supports the Life Sciences
Leibniz Institute of Photonic Technology

14:30
Reimbursement and Cost of Quality
BeyondSpring Pharma

15:00
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

16:00
Summary, Conclusions Closing Remarks End of Conference & Farewell
Falk Klar, PDA Europe

4 Ways to register

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?

Member

By 16 April 2017
1,395 Euro

After 16 April 2017
1.595 Euro

Nonmember

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%)

Contact

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

Exterior

Hilton Berlin
Mohrenstraße 30
10117 Berlin
Germany
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)

Parking

On-site parking fee, inquire at the hotel desk

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

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