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Parenteral Drug Association Connecting People, Science and Regulation ®

Pre-Conference-Workshop Impact of Pre-filled Syringe Packaging Components on Biopharmaceuticals

Nov 06 - Nov 06, 2017 |
Nov 06, 2017 |
Austria Center Vienna | Vienna, Austria
  • Education
  • Workshop
  • Europe
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Parenteral drug delivery using pre-filled syringes and cartridges in combination with devices is of great importance, especially for the application of biopharmaceutical products.

The development of such delivery systems is complex and therefore it is important to consider critical aspects early on in development. This workshop considers the potential influences of primary packaging components on the quality, in particular for biopharmaceuticals. The most relevant aspects are the quality and the chemical and physical interactions of the packaging material with the product. Special considerations are given to the influence of particles, extractables and leachables, silicon oil and handling on the product quality, e.g. aggregation, degradation routes and stability. Experts from academia, the pharmaceutical industry and suppliers of packaging components will share their experiences. There will be plenty of time for discussion, interaction and questions you may have.

Monday, 6 November 2017

10:00
Welcome
William Dierick,
Director, Technology Development – Pharmaceutical Solutions, Co-Chair, TERUMO
John Carpenter, Professor of Pharmaceutical Sciences, Co-Chair,University of Colorado

KEYNOTE PRESENTATIONS

10:10
Aggregates, Particles and Patient Immunogenicity with Biopharmaceuticals
John Carpenter, University of Colorado

10:40
Factors Affecting Stabilities of Biopharmaceuticals in Pre-filled Syringes
Susumu Uchiyama, Osaka University

11:10
Packaging Components and Biopharmaceuticals: Quality Aspects from Industry Perspective
Hanns-Christian Mahler, Lonza

11:40
Q&A - Discussion

12:00
Coffee Break

Session 1 Aggregation Phenomena

13:00
Protein – Device Compatibility
Flora Felsovalyi, Roche

13:30
Characterization of Particles and Practical Implications
Linda O. Narhi, Amgen

14:00
Ex-Vivo Risk Assessment of Immunogenicity
Mark Fogg, Abzena

14:30
Q&A - Discussion

15:00
Coffee Break

Session 2 Particles

15:30
Particulates in Sterile Drug Products: Testing, Contributions and Mitigation from Packaging Components
Fran DeGrazio, West

16:00
Particles in Packaging Components: Numbers and Chemical Composition
Markus Lankers , Rap.ID

16:30
Q&A - Discussion


Session 3 Extractables & Leachables>

16:45
Extractables and Leachables: Impact of Packaging Components on Biopharmaceuticals
Piet Christiaens, Toxikon


Session 4 Functionality

17:15
Needle Clogging of Staked-In-Needle PFS with High Concentration Protein Therapeutics
Monica De Bardi, Roche

17:45
Q&A - Discussion

17:55
Closing Remarks by Co-Chairs

18:00
End of Workshop

4 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).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

795 Euro

All fees given in Euro and excluding VAT (23%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Austria Center Vienna
Internationales Amtssitz- und Konferenzzentrum Wien, AG
Bruno-Kreisky-Platz 1
A-1220 Vienna

Hotel Accommodation

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2017 . We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.

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://www.pda.org/docs/default-source/website-document-library/eu-conferences/2017/the-universe-of-prefilled-syringes/registration-form.pdf

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