Particles in Injectables Conference - PDA Exchange Series

Berlin, Germany
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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!

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

Event Location
Berlin Marriott Hotel
Inge-Beisheim Platz 1, Berlin, Germany Get Directions

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
Christopher Haertig
[email protected]
Registration Customer Care

Standard Pricing

Standard Member Price

€1.695

GovernmentMember Only

€850

Health AuthorityMember Only

€850

Early Career ProfessionalMember Only

€850

AcademicMember Only

€850

Non-Member

€1.995

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

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



Day 2

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

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 , Germany

+49 (0)30-220000

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
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.