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2019 Exchange Series

Particles in Injectables Conference - PDA Exchange Series

Sep 24 - Sep 25, 2019
Berlin, Germany

  • Conference
  • Europe

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Program Highlights

This year, the conference will be part of the PDA Europe Exchange Series!
Experience two meetings held at the same time when the Particles in Injectables meets Pharmaceutical Freeze Drying Technology!

Overview

Dear Colleagues,

On behalf of PDA Europe and the Scientific Program Planning Committee, we are delighted to invite you to join the 2019 conference on Particles in Injectables, in Berlin, Germany on 24-25 September.

With this year’s theme From the Factory to the Patient the Particles in Injectables conference aims to provide a conclusive summary of the most recent information

on the risks to human health associated with particulate matter. Particles can arise from many sources within the manufacturing and administration process: foreign, intrinsic,

or inherent to the product. Particulate matter, visible or subvisible, in sterile parenteral products is regarded a critical quality attribute, impacting patient safety. The conference will review the nature and the sources of particles in parenterals and in infusion sets used in clinical studies and hospitals. The difference between particles in drugs and clinical infusions

will be examined. Packaging materials, such as glass vials, syringes and rubber stoppers are known to be major sources of particulate contamination. The use of particle standards to

qualify manual and automated inspection systems, control of critical inspection parameters, as well as the development of reliable inspection methods will be highlighted.

This year, the conference will again be part of the PDA Europe Exchange Series, taking place in parallel to the conference on Pharmaceutical Freeze Drying Technology. Take advantage of this 2-for-1 deal today!

We look forward to welcoming you to Berlin!

Sincerely,
The Co-Chairs

John Shabushnig, PhD, Insight Pharma Consulting
John Ayres, MD, Pharma Safety Solutions

Agenda

  • Day 1
  • Day 2
  • Tuesday, 24 September 2019

    9:00 – 9:20
    Welcome and Introduction

    Kerstin Wilken, PDA Europe
    Yves Mayeresse, GSK Vaccines, Chair Pharmaceutical Freeze Drying Technology
    Julian Gitter, University of Munich, Chair Pharmaceutical Freeze Drying Technology

    Falk Klar, PDA Europe
    John Shabushnig, Insight Pharma Consulting, Chair Particles in Injectables
    John Ayres, Pharma Safety Solutions, Chair Particles in Injectables

    9:20 - 9:50
    KEYNOTE – Practical Approaches to Patient Safety
    Michael Sasse, Medical School Hannover

    9:50 - 11:15
    Joint Opening Plenary: Regulatory Updates
    John Ayres, Pharma Safety Solutions
    Julian Gitter, University of Munich

    An Update on USP & the European Pharmacopoeia
    Hanns-Christian Mahler, LONZA
    John Shabushnig, Insight Pharma Consulting

    Regulatory Considerations for Particulate Control in Injectable Products
    Stephen Langille, ValSource

    Q&A, Discussion

    11:15 - 11:45
    Coffee Break, Poster Session & Exhibition

    Transition to Parallel Tracks

    PARTICLES IN INJECTABLES
    11:45 - 13:15
    Session 1: In-line Filter Systems
    Moderator: Cornelia Keck, Philipps-University, Marburg

    11:45 -12:15
    In-line Filters, a Way to Limit Particles Exposition to Patients?
    Stephanie Genay, University of Lille

    12:15 -12:45
    In-Line Filtration Reduces Postoperative Phlebitis - An Analysis on Effectiveness, Costs and Patients Perspective
    Gianluca Villa, Università degli Studi di Firenze

    12:45 -13:15
    Q&A, Discussion

    PHARMACEUTICAL FREEZE DRYING TECHNOLOGY
    11:45 - 13:15
    Session 1: Evolution in Lyo-Technologies
    Moderator: Raf De Dier, Janssen J&J

    11:45 -12:15
    Aseptic Spray Freeze Drying - Modelling, Application & Scale Up
    Bernhard Luy, Meridion Technologies

    12:15 -12:45
    Controlled vs Spontaneous Nucleation – Comparison of Drying Behavior, Residual Moisture and Cake Appearance
    Benjamin Ledermann, GEA Lyophil

    12:45 -13:15
    Q&A, Discussion

    13:15 - 14:15
    Lunch Break, Poster Session & Exhibition

    PARTICLES IN INJECTABLES
    14:15 - 15:45
    Session 2: ATMPs & Cell and Gene Therapies
    Moderator: Stephen Langille, ValSource

    14:15 - 14:45
    Challenges of Particulates in Cell Therapies
    Klaus Wormuth, Sartorius Stedim

    14:45 - 15:15
    Flow Imaging with Rapid Classification of Particles using Machine Learning for Characterization of Cell Therapies
    Amber Fradkin, KBI Biopharma

    15:15 - 15:45
    Q&A, Discussion

    PHARMACEUTICAL FREEZE DRYING TECHNOLOGY
    14:15 - 15:45
    Lyo-Considerations: Glass and its Implications on the Freeze Drying Process
    Moderator: Yves Mayeresse, GSK Vaccines

    14:15 - 14:45
    Applying Innovations in Packaging to Increase Drug Product Quality by Addressing the Root Cause of Issues Associated with Conventional Glass Containers
    Carol Flynn, Corning

    14:45 - 15:15
    Investigating Vial Breakage Using Strain Gauge Technology
    Raf De Dier, Janssen J&J

    15:15 - 15:45
    Q&A, Discussion

    15:45 - 16:15
    Coffee Break, Poster Session & Exhibition

    PARTICLES IN INJECTABLES
    16:15 - 18:00
    Session 3: Particles Derived from Container Closure Systems
    Moderator: John Shabushnig, Insight Pharma Consulting

    16:15 - 16:40
    PDA Task Force for Zero Defects for Visible Particles in Injectables
    Tia Bush, Amgen

    16:40 - 17:05
    A Case Study for Mitigation of Visual Particulate in Glass Ready-to-Use Vials
    Anthony Vico, Stevanato Group
    Elizabeth Jane Pavlik, MSD

    17:05 - 17:30
    Method for Quantifying Loose Particles on Elastomeric Components
    John Rech, WEST
    Ravi Patel, WEST

    17:30 - 18:00
    Q&A, Discussion

    PHARMACEUTICAL FREEZE DRYING TECHNOLOGY
    16:15 - 18:00
    Session 3: Changing the Focus: Reconstitution, Inspection of Lyophilized Products and Digitalization

    16:15 - 16:40
    NIR Modelling for Moisture Content Determination based on a Design of Experiment Approach
    Matthieu Clavaud, F. Hoffmann-La Roche

    16:40 - 17:05
    Workflow of Deep Learning in a Pharmaceutical Environment
    Christian Kolic & Patrick Hess, Seidenader

    17:05 - 17:30
    Towards Digitalization of Pharma Industry: Advanced Design of Experiments Approaches to Generate Highly Informative Data for Lyophilization Process Development
    Emanuele Tomba, GSK Vaccines

    17:30 - 18:00
    Q&A, Discussion

    18:00
    End of Conference Day 1 & Networking Event



  • Wednesday, 25 September 2019

    PARTICLES IN INJECTABLES

    9:00 - 9:05
    Welcome
    John Shabushnig, Insight Pharma Consulting
    John Ayres, Pharma Safety Solutions

    9:05 - 10:30
    Session 4: Clinical Impact of Particles
    Moderator: Ton van Boxtel, WoCoVA

    9:05 - 9:35
    In Vivo Fate of Nanoparticles – Is It Predictable?
    Cornelia Keck, Philipps-University Marburg

    9:35 - 10:05
    A Clinical Perspective on Particulates
    John Ayres, Pharma Safety Solutions

    10:05 - 10:30
    Q&A, Discussion

    PHARMACEUTICAL FREEZE DRYING TECHNOLOGY

    9:00 - 9:05
    Welcome
    Yves Mayeresse, GSK Vaccines
    Julian Gitter, University of Munich

    9:05 - 10:30
    Session 4: Formulation and Process Development
    Moderator: Jörg Lümkemann, F. Hoffmann - La Roche

    9:05 - 9:35
    Effective Stabilization of Viral Vectors by Lyophilized SPS® Formulations Adenovirus Serotype 5 as a Model
    Sabine Hauck, LEUKOCARE

    9:35 - 10:05
    Process Development Concepts for Freeze-Drying of Highly Potent Agents
    Claudia Kunz, Merck Healthcare KGaA

    10:05 - 10:30
    Q&A, Discussion

    10:30 - 11:00
    Coffee Break, Poster Session & Exhibition

    PARTICLES IN INJECTABLES
    11:00 - 12:30
    Session 5: Particle Identification
    Moderator: Markus Lankers, MIBIC

    11:00 - 11:30
    The New VDI 2083 Part 21: Cleanliness of Medical Products in the Manufacturing Process
    Markus Rochowicz, Fraunhofer IPA

    11:30 - 12:00
    Particulate Investigations in Injectables
    Pascal Chalus, LONZA

    12:00 - 12:30
    Q&A, Discussion

    PHARMACEUTICAL FREEZE DRYING TECHNOLOGY
    11:00 - 12:30
    Session 5: Non-Destructive CQA Analysis
    Moderator: Julian Gitter, University of Munich

    11:00 - 11:30
    Non-Invasive Methods for Moisture Mapping and Container Closure Integrity
    Kumar Khamar, Sanofi Waterford

    11:30 - 12:00
    Assessing Critical Quality Attributes for Freeze-Dried Products
    Jos Corver, Ghent University / Rhea Vita

    12:00 - 12:30
    Q&A, Discussion

    12:30 - 13:30
    Lunch Break, Poster Session & Exhibition

    PARTICLES IN INJECTABLES
    13:30 - 14:30
    Session 6: Panel Discussion
    Moderator: Klaus Wormuth, Sartorius Stedim

    • Compatibility and Interactions of Delivery Systems and Drug Product
    • Evolving Guidance & Regulations and their Implementation

    PHARMACEUTICAL FREEZE DRYING TECHNOLOGY
    13:30 - 14:300
    Session 6: Roundtable Discussions
    Moderator: Kerstin Wilken, PDA Europe

    1. Product Validation, Number of batches needed, Batch Size, Bracketing, Matrixing Sstrategies, Robustness of Lyo-Cycle
    2. Use of PAT Tools in Commercial Process Control, Regulatory Filings
    3. Implementation of New Technologies & Novel Therapies

    14:30 - 15:00
    Coffee Break, Poster Session & Exhibition

    15:00 - 16:30
    Joint Plenary - Closing Keynotes
    Moderators: John Shabushnig, Insight Pharma Consulting
    Yves Mayeresse, GSK Vaccines

    15:00 - 15:30
    Control Strategy for Visible Particles in Lyophilized Products
    Alexis Flaquière, GSK Vaccines

    15:30 - 15:50
    The Future of Product Differentiation: Increase Patient Safety and Decrease Healthcare Cost When Using Freeze Dried Products
    Joerg Luemkemann, F. Hoffmann - La Roche

    15:50
    Conference Summaries by the Co-Chairs

    John Shabushnig, Insight Pharma Consulting, Chair, Particles in Injectables
    John Ayres, Pharma Safety Solutions, Chair, Particles in Injectables

    Yves Mayeresse, GSK, Chair, Pharmaceutical Freeze Drying Technology
    Julian Gitter, University of Munich, Chair, Pharmaceutical Freeze Drying Technology

    16:30
    Closing Remarks & Farewell
    Falk Klar, PDA Europe
    Kerstin Wilken, PDA Europe


Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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Travel

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.

Berlin Marriott Hotel

Inge-Beisheim Platz 1
Berlin, Germany
Phone: +49 (0)30-220000

Berlin Marriott Hotel
  • Accommodations

    Hotel Website

    Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

    Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

    Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

    PDA Europe has reserved a limited number of rooms until the 26th July 2019.
    Book Your Room for the PDA Group Rate

    Single Room € 195 per night*
    Double Room € 215 per night*

    *Rates are per room and night, including the following services and benefits:
    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airports:

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 60911150
5.6 mi (9 km), 18 min by car
Alternate transportation: Limousinen Service; fee: 100 EUR (one way); reservation required
Estimated taxi fare: 25 EUR (one way)
Bus service, fee: 2.8 EUR (one way)
Subway service, fee: 2.8 EUR (one way)
Take the Bus X9 and get off at Zoologischer Garden, then take the subway U2 towards Pankow and get off at Potsdamer Platz.

OR

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 60911150
12.7 mi (20.4 km), 25 min by car
Alternate transportation: Limousinen Service; fee: 130 EUR (one way); reservation required
Estimated taxi fare: 45 EUR (one way)
Bus service, fee: 3.6 EUR (one way)
Subway service, fee: 3.6 EUR (one way)
Take the train S45 to S-Bahnhof Suedkreuz. Then change to the S-train S2 and get off at Potsdamer Platz.

By Car

The Berlin Marriott Hotel is located at Inge-Beisheim Platz 1.

Other Options

Berlin Central Station: 2.3 mi from hotel.

Train Station Berlin Friedrichstrasse: 1.1 mi from hotel.

Directions

Registration Fees

Early Registration
Registration Type Price by 28 July
Member €1.495
Non-member €1.795
Govern./Health Authority/Academic €650
Young Professional (Member) €650




Regular Registration
Registration Type Price after 28 July
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €850
Young Professional (Member) €850

All fees given in Euro and excluding VAT




* 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.

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