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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!

Overview

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.

Agenda

  • 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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:


    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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