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

Name: Pre-Conference-Workshop Impact of Pre-filled Syringe Packaging Components on Biopharmaceuticals
Start: 2017-11-06
End: 2017-11-06

Nov 06, 2017

Vienna, Austria

Education
Workshop

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Europe

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Overview
Agenda
Additional Information
Travel
Registration Fees
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Overview

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.

Agenda

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

Additional Information

Who Should Attend

More information coming soon.

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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.

Austria Center Vienna

Bruno-Kreisky-Platz 1
Vienna, Austria

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.

How to Get Here

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Directions

Registration Fees

Regular Price

For your credit card information safety: Please send your details by fax only
For an easier registration, please note the helpful hints on the registration form

4 Ways to register

Online Registration
FAX: +49 30 436 55 08 66
[email protected]
Mail: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

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

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

All prices in Euro (EUR), excluding VAT

For your credit card information safety: Please send your details by fax only

For an easier registration, please note the helpful hints on the registration form

Ways to Register

Online Registration
FAX: +49 30 436 55 08 66
[email protected]

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).
Please contact us if you are entiteld to receive a discount

Antje Petzholdt

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

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