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Parenteral Drug Association Connecting People, Science and Regulation ®

Parenteral Packaging

Feb 27 - Feb 28, 2018 |
Feb 28, 2018 |
Marriott Park Hotel Rome | Rome, Italy
  • Conference
  • Europe
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You are warmly invited to join us in our ongoing professional discourse of latest manufacturing technologies and business trends in the Parenteral Packaging arena.

PDA Europe’s Conference has proven to be a must-attend event for professionals in this field.

Join us in Rome / Italy, 27-28 February 2018 to continue and further deepen scientific advancements and understanding of topics previously raised in this successful annual event.

As proper packaging of pharmaceuticals is crucial to drug stability, this conference and the accompanying exhibition address quality of components and containers as much as aspects of processing, product distribution and storage.

Excellent speakers from the industry, regulatory and academia will give detailed information about opportunities and challenges the advancing pharmaceutical packaging market faces. The conference aims to keep its attendees updated about all regulatory aspects involved in the parenteral packaging process, such as new regulations from European and US agencies, the revision of Annex 1, and PDA Technical Reports. Different materials such as glass, polymers & elastomers and their characteristics regarding supplier issues and end-user preferences will also be discussed, as well as the design of primary and secondary packaging.

The role of Container Closure Integrity (CCI) in product-package development, post-approval product changes and routine manufacturing will be explored, and information on aseptic processing will be given. Of equal importance to the content is to interact with the speakers and your fellow attendees. Rome will offer a comfortable yet exciting atmosphere for exchange during refreshment breaks, on-site lunches and evening receptions. Join PDA Europe’s Parenteral Packaging Conference in one of the most beautiful cities in the world.

Welcome to Rome!

The Chairs

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Tuesday, 27 February 2018

9:00
Welcome and Introduction
Kerstin Wilken, PDA Europe
Roger Asselta, Co-Chair, Genesis Packaging
Roman Mathaes,Co-Chair, LONZA

9:15 - 11:15
Opening Plenary Session 1: International Regulatory Updates
Moderator: Renaud Janssen, Datwyler

9:15
Annex 1 Revision & CCIT
Andrew Hopkins, MHRA

9:45
Secondary Packaging Considerations & Last Mile Distribution
Umit Kartoglu, WHO

10:15
A Risk-based Approach for Assessment of Pharmaceutical Packaging of Parenterals - A Regulatory Perspective
Charudharshini Srinivasan, US FDA

10:45
Q&A, Discussion

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

11:45 - 13:45
Session 2: Packaging Technology Updates
Moderator: Roman Mathaes, LONZA

11:45
Usability of Glass versus Polymer Ampoules: A Comparison
Michael Spallek, Rommelag

12:15
Impact of Drug Formulation Variables on Packaging Functionality
Galen Shi, Eli Lilly

12:45
Engineering Considerations: Pressure and Strain Waves in Pre-Filled Syringes during Autoinjector Activation
Julian Jazayeri, Amgen
Jean-Christophe Veilleux, California Institute of Technology

13:15
Q&A, Discussion

13:45 – 14:45
Lunch Break, Poster Session & Exhibition

14:45 – 18:15
PARALLEL TRACKS

Session 3 Track A: Manufacturing Process
Moderator: Daniel Wagner, Sanofi

14:45
Investigations Carried Out on Clean Room Injection Molding of Plastic Components for Parenteral Packaging
Reinhard Steger, Braunform

15:15
From Blow-fill-seal Ampoules to Advanced Container Closure Systems by Blow-Fill-InsertSeal: A review based on three case studies
Otto Schubert, Rommelag


Session 3 Track B: Packaging Material: Glass
Moderator: Claudia Heinl, Schott

14:45
Reduction of Particulate Contamination Generated During Bulk Vial Filling
Christopher Timmons, Corning

15:15
Extractables Profiles of Borosilicate and Aluminosilicate Glass – A Comparison
Folker Steden, Schott

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

Session 3 Track A: Manufacturing Process
Moderator: Daniel Wagner, Sanofi

16:15
Case Study: Mid-Scale Production Line for Aseptic Filling and Sealing of IV-Bags
Bernhard Brugger, Harro Hoeflinger

16:45
Filling and Stoppering Processes for Cartridges and Syringes
Klaus Ullherr, Robert Bosch Packaging

17:15
Critical Time- & Temperature- Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle
Qingyu Zeng, West

17:45
Q&A, Discussion


Session 3 Track B: Packaging Material: Glass
Moderator: Claudia Heinl, Schott

16:15
Lyophilization of Nested Glass Containers: Process Investigation
Lorenza Bonaldi, Stevanato

16:45
Fused Quartz Vials for Enhanced Chemical Stability
Ben Gauthier, Momentive

17:15
Glass Packaging Breakages: A New Testing Protocol for the Optimization of Container Filling Lines
Nicola Favaro, Stazione Sperimentale del Vetro

17:45
Q&A, Discussion

18:30
Networking Dinner

Wednesday, 28 February 2018

9:00 - 10:15
Session 4 Regulatory Updates
Moderator: Roger Asselta, Genesis Packaging

9:00
USP Updates
Bettine Boltres, USP

9:25
Elastomeric Closures - Regulatory Updates
Renaud Janssen, Datwyler

9:50
ISO Norms Update: Rigid Container Systems and Related Accessories for Parenterals and Injectables ISO/TC 76/WG2
Volker Rupertus, Schott

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

10:45 – 13:00
PARALLEL TRACKS

Session 5 Track A: Container Closure Integrity & Testing
Moderator: Bettine Boltres, USP

10:45
A Case Study to Address a Gap in the Device-to-Vial Interface: Stopper Push-in by Chemo Spikes – An Overlooked Oncology Safety Risk
Cathy Zhao, WEST

11:10
Container Closure Integrity: Specific Strategies for Unique Applications
Oliver Stauffer, pti

11:35
Proposal for Implementing the RSF Tester in a Manufacturing Environment
Robert Ovadia, Genentech

12:00
Development of a Platform High Voltage Leak Detection Method for Drug Product Container Closure Integrity Testing
Jason E. Fernandez, Biogen

12:25
Q&A, Discussion


Session 5 Track B: Polymers: E&L Considerations
Moderator: Renaud Janssen, Datwyler

10:45
Polymeric Materials in Primary Containers and Medical Devices – A Lilly Perspective
Karthik Vaideeswaran, Eli Lilly

11:10
Advancing Flexibility, Softness and Transparency with Polybutene-1 for Parenteral Applications
Isabelle Trocherie, LyondellBasell

11:35
Effect of Ageing of Elastomeric Closures on their Physico/Chemical Properties and their Extractables Profile
Bram Jongen, Datwyler

12:00
Extractables and Leachables Evaluation of Single Use Systems for Biopharmaceuticals Moving Toward Standardization by Up-Coming USP <1665>/<665>
Andreas Nixdorf, SGS Institut Fresenius

12:25
Q&A, Discussion

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

14:00 - 16:30
Closing Plenary Session 6: Latest in Manufacturing & Technology
Moderator: Roger Asselta, Genesis Packaging - Roman Mathaes, LONZA

14:00
Use of a Wireless Drone System for Improvement of Pharmaceutical Manufacturing Processes
Joe Norris, SmartSkin
David Brückner, F. Hoffmann-La Roche

14:30
State of Packaging and Testing Technology: Parenteral Cryo Solutions
Chris Folta, Janssen J&J

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

15:30
Systematic Assessment of pCCIT Method Performance and Commonly Used Artificial Leaks

16:00
Q&A, Discussion

16:30
End of Conference & Farewell

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 7 January 2018
1.395 Euro

After 7 January 2018
1.595 Euro

Nonmember

By 7 January 2018
1.695 Euro

After 7 January 2018
1.895 Euro

Govern./Health Authority/Academic

By 7 January 2018
700 Euro

After 7 January 2018
800 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

Marriott Park Hotel Rome
Via Colonnello Tommaso Masala 54
00148 Rome
Italy
Tel: +39-06-658821
Hotel Website

The Rome Marriott Park Hotel offers an uncommon blend of convenience and sophistication. With an outstanding location just minutes from Rome's Fiumicino Airport and a vast selection of top-quality amenities, our hotel sets the stage for a remarkable experience in the Eternal City.

Thoughtfully designed hotel rooms feature handcrafted furniture and elegant marble bathrooms, in addition to modern comforts such as a flat-screen TV. We're one of Rome's premier venues for any business meeting or event, with an astonishing 126,971 square feet of adaptable space and an expert planning staff. Satisfy your cravings here in Rome with delicious on-site dining, or take a leisurely swim in our seasonal outdoor pool.

Our well-placed hotel is only 10 miles from Fiumicino Airport and from world-renowned destinations, including Vatican City and the Colosseum. For added convenience, a shuttle service to and from central Rome is available.

PDA Europe has reserved a limited number of rooms until the 19th December 2017.
Book your room for the PDA Group Rate.

Single Room € 100 per night*
Double Room € 120 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

Fiumicino Airport – FCO
Airport Phone: +39 06 65951

Hotel direction: 10.2 miles NE
Airport shuttle service, scheduled, fee: 5 EUR (one way)

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=4044

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