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Parenteral Drug Association Connecting People, Science and Regulation ®

Parenteral Packaging

Interaction of Product, Package, and Process
Mar 19 - Mar 20, 2019 |
Mar 20, 2019 |
Hilton Molino Stucky Venice | Venice, Italy
  • Conference
  • Europe
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Dear Colleague,

Primary packaging of pharmaceutical dosage forms should be designed, manufactured, processed and assembled in a way that does not alter the safety, identity, strength, quality or purity of the drug product beyond the established requirements. With complex forms of pharmaceuticals such as biologics entering the market, special requirements for handling, storage and packaging need to be met. Different materials such as glass and their characteristics regarding supplier issues, interactions with the drug product and end-user preferences will be discussed as well as the latest regulatory updates such as the Annex 1 of the European GMP Guideline and USP 800. Topics to be explored will further include some of the latest developments in packaging materials & components and the role of Container Closure Integrity (CCI) in product-package development, assembly and processing. The week’s program of the 2019 PDA Europe Parenteral Packaging conference is intended to initiate and support discussion and professional exchange through a diversity of scientific presentations, workshops, training courses, joint dinners and networking events.

We look forward to you joining us in amazing Venice!

Sincerely,
The Co-Chairs

Roger Asselta, Genesis Packaging Technologies
Roman Mathaes, Lonza

Download Call for Papers

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Tuesday, 19 March 2019

9:00 – 9:15
Welcome and Introduction
Kertin Wilken, PDA Europe
Roger Asselta,, Genesis Packaging Technologies
Roman Mathaes, Lonza

OPENING PLENARY

9:15 – 9:45
Keynote: The Evolution of Parenteral Drug Substance and Drug Product Primary Containers
Karthik Vaideeswaran, Eli Lilly

9:45 – 12:45
Session 1: Packaging Considerations for Cold Storage
Moderator: Derek Duncan, LIGHTHOUSE

9:45 – 10:15
Primary Container Design for Drug Substance at Cryo- and Cold Temperatures
Ronald Iacocca, Eli Lilly

10:15 – 10:45
Q&A, Discussion

10:45 –11:15
Coffee Break, Poster Session & Exhibition

11:15 – 11:45
Nonlinear Finite Element Simulation of Frozen Container Closure Systems
Holger Roehl, Roche

11:45 – 12:15
Case Study: Ensuring Container Closure Integrity of a Gene Therapy Cancer Vaccine in Need of Deep Cold Storage
Josine Wilmer, LIGHTHOUSE

12:15 – 12:45
Q&A, Discussion

12:45 –14:00
Lunch Break, Poster Session & Exhibition

PARALLEL TRACKS

14:00 – 15:40
Session 2A: Glass
Moderator: Claudia Heinl, SCHOTT

14:00 – 14:20
Delamination in Glass Containers for Pharmaceutical Application: The International Commission on Glass (ICG) Technical Committee TC12
Massimo Guglielmi, University of Padova

14:20 – 14:40
Innovations in Glass Production
Robert Hayes, Gerresheimer

14:40 – 15:00
A Case Study for Mitigation of Visual Particulate in Glass Ready-to-Use Vials
Anthony Vico, Stevanato Group
Elizabeth Jane Pavlik, MSD

15:00 – 15:20
New Parenteral Glass Packaging Option May Lead to Reduction in Particulates and Ultimately Drug Shortages
Kyle Hoff, Corning

15:20 – 15:40
Q&A, Discussion

14:00 – 15:40
Session 2B: Manufacturing in the Digital Age
Moderator: Bettine Boltres, WEST

14:00 – 14:20
Identification and Quantification: Multisensor Drone Technology
Fabian Thygs, Janssen J&J

14:20 – 14:40
Comprehensive Container Closure System (CCS) Stack-up Simulation and Optimization in the Digital Age
Anthony Bucci, WEST

14:40 – 15:00
Testing and Computational Modelling in the Study of Cartridge Failure
Daniela P. Boso, University of Padova

15:00 – 15:20
Quantifying the Vial Capping Process Using Micro-Computed Tomography
Robert Ovadia, Genentech

15:20 – 15:40
Q&A, Discussion

15:40 – 16:10
Coffee Break, Poster Session & Exhibition

16:10 – 18:00
Session 3A: Considerations on Container Closure Integrity
Moderator: Roger Asselta, Genesis Packaging Technologies

16:10 – 16:40
Balancing Container Closure Integrity and Aesthetics for Robust Primary Packaging
Yusuf Oni, Bristol-Myers Squibb

16:40 – 17:10
Container Closure Integrity Testing – Method Development for Freeze- Dried Products Using Laser-based Headspace Oxygen Analysis
Soren Dahl, Novo Nordisk

17:10 – 17:40
Interlaboratory Study of Container Closure Integrity He-leak Test Method - Comparison of Different Types of Artificial Leaks
Klaus Wuchner, Janssen J&J
Daniel Wagner, Sanofi

17:40 – 18:00
Q&A, Discussion

16:10 – 18:00
Session 3B: Chemical Interactions of Drug Product and Primary Packaging
Moderator: Galen Shi, Eli Lilly

16:10 – 16:40
The Advantages of Considering Primary Container Systems as an Excipient During Formulation Development
Cathy Zhao, WEST

16:40 – 17:10
Comparative Leachable Study for Glass Vials to Demonstrate the Impact of Low Fill Volume
Volker Rupertus, SCHOTT

17:10 – 17:40
Interactions of Leachables with Proteins: Combined In-Silico and Experimental Model to Monitor the Potential Impact on Quality and Safety of Therapeutic Proteins
Piet Christiaens, Nelson Labs

17:40 – 18:00
Q&A, Discussion

18:00
End of Day 1 and Networking Event

Wednesday, 20 March 2019

9:00 – 9:30
Keynote: Keynote: Getting Ready for Annex1 and USP 800
Roman Mathaes, Lonza
Hanns-Christian Mahler, Lonza

9:30 – 11:30
Session 4: Regulatory Updates
Moderator: Daniele Zuccato, Stevanato Group

9:30 – 10:00
Chinese Regulatory Update
Yonghua Gao, CNPPA

10:00 – 10:30
USP Chapter Changes on Glass and Rubber
Bettine Boltres, WEST
Renaud Janssen, Datwyler

10:30 – 11:00
ISO Standard Series ISO 11040 on Pre-filled Syringes, Updates on ISO Technical Committees TC76 and TC84
Horst Koller, HK Packaging

11:00 – 11:30
Q&A, Discussion

11:30 – 12:00
Coffee Break, Poster Session & Exhibition

PARALLEL TRACKS

12:00 – 13:00
Session 5A: Challenges in Development & Manufacture
Moderator: Renaud Janssen, Datwyler

12:00 – 12:25
A Quality by Design Approach Toward Manufacturing of Elastomeric Components for Parenteral Packaging Applications
Rahul Thakar, Datwyler

12:25 – 12:50
Multi-Chamber IV Bag Film Development
William Roberts, Sealed Air Corporation

12:50 – 13:00
Q&A, Discussion

12:00 – 13:00
Session 5B: Sterilization of Packaging
Moderator: Joerg Zuercher, Bayer

12:00 – 12:25
Validation of VH2O2 Sterilization Process per ISO14937
Juha Mattila, STERIS

12:25 – 12:50
Alternative Sterilization Techniques for Elastomeric Components for Primary Packaging
Bram Jongen, Datwyler

12:50 – 13:00
Q&A, Discussion

13:00 – 14:00
Lunch Break, Poster Session & Exhibition

CLOSING PLENARY

14:00 – 16:30
Session 6: Primary Packaging & Development Considerations
Moderator: Roman Mathaes, Lonza

14:00 – 14:30
Factors Influencing Quality of Biopharmaceuticals in Pre-filled Syringes
Susumu Uchiyama, Osaka University

14:30 – 15:00
Lyophilization in Pre-filled Syringes: Evaluating the Influence of Primary Container Material and Loading Device
Timothy Dutill, Lyophilization Technologies
Kevin Constable, Terumo

15:00 – 15:30
Lunch Break, Poster Session & Exhibition

15:30 – 16:00
Quality of Components & Containers – Design, Materials, New Technologies
Robert Hormes, Novartis

16:00 – 16:30
Q&A, Discussion

16:30
End of Conference & Farewell
Kertin Wilken, PDA Europe
Roger Asselta,, Genesis Packaging Technologies
Roman Mathaes, Lonza

3 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).

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 03 February 2019
1.495 Euro

After 03 February 2019
1.695 Euro

Nonmember

By 03 February 2019
1.795 Euro

After 03 February 2019
1.995 Euro

Govern./Health Authority/Academic

By 03 February 2019
750 Euro

After 03 February 2019
850 Euro

All fees given in Euro and excluding VAT (22%)

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 Molino Stucky Venice
Giudecca, 810
30133 Venezia
Italy
Tel: +39 041 272 3311
Hotel Website

Once a flourishing flourmill, Hilton Molino Stucky Venice has been beautifully restored and offers a different view of the magical city of Venice. Just 30 minutes from the airport, we also offer a shuttle boat service to the city center. With 379 rooms and suites, the largest Congress Center and the second largest spa in Venice, a collection of bars and restaurants and a stunning rooftop pool, our hotel is the perfect location for your stay in Venice.

The comfort of their guests is a commitment reflected in the quality and finishes of their 379 rooms. Designed to be a place to unwind, all the rooms offer elegant amenities, spacious marble bathrooms and comfortable beds. Treat yourself with an upgrade and enjoy breathtaking views or access to the Executive Lounge.

Experience a real taste of the Mediterranean in the elegant Aromi restaurant or savor the authentic flavors of Venetian cuisine at Bacaromi. Spoil yourself with Nutella desserts or relax with a coffee at the lounge. Sip a cocktail Skyline Rooftop Bar enjoying outstanding views over Venice.

PDA Europe has reserved a limited number of rooms until the 19th December 2018.
Book your room for the PDA Group Rate.

Single Room € 209 per night*
Double Room € 239 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • VAT, Taxes and Service Charge will apply

How to Get There

Venice Marco Polo Airport – VCE
Airport Phone: +39 041 260 9260

Hotel direction: 17 km

Airport shuttle service
Hotel Station
: Giudecca Stucky

  • Public Boat: approx. €15 per passenger (one way)
  • Public Bus: approx. €8 per passenger (one way)
  • Public Taxi: approx. €35 per passenger(one way)
Linea Blu Timetable-Public Transportation -Water Taxi - Hilton Venice

Parking

  • On-site parking, fee: 4 EUR hourly, 12 EUR daily

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

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4507

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