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2019 UPS

Impact of Pre-Filled Syringe Components on Biopharmaceuticals Workshop

Oct 21, 2019
Gothenburg, Sweden

  • Workshop
  • Europe
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Program Highlights

PDA is planning a series of workshops as a kick-off to the Universe of Pre-filled Syringes Meeting. The workshop topics are soon to be published – check the website regularly or to send us an email we will inform you when these go online.

Overview

Biotherapeutics remain the largest growing segment in the pharmaceutical industry, spurred by various technological advancements in many fields and with further progress in understanding diseases. Moreover, advanced therapy medicinal products (ATMPs) offer ground-breaking new opportunities for the treatment of currently untreatable diseases or provide for additional effective and curative treatment options.

These advances in pharmacotherapy are also giving challenges and hurdles, with regulators becoming increasingly stringent. It is critical to consider potential interactions with primary packaging components and direct contact materials. The importance of pre-filled syringes and other pre-filled drug containers, often used in combination with drug delivery devices, cannot be underestimated within this space of parenteral drug delivery.

This workshop will address various aspects regarding potential influences from primary packaging components and materials on drug quality, safety and efficacy, including the influence of sub-visible particles, extractables and leachables, silicone oil, handling and manipulation, e.g. aggregation, protein degradation routes and stability.

This workshop will bring together experts from academia, the pharmaceutical industry and providers of primary packaging components to share their experiences. There will be plenty of time allocated for discussion and interaction with the audience.
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Agenda

  • Monday, 21 October 2019

    10:00 – 17:00

    10:00
    Welcome: Opening Remarks & Introductions
    William Dierick, Terumo
    Philippe Lauwers, Terumo
    Roman Mathaes, Lonza
    Wenzel Novak, Gerresheimer
    Bernd Zeiss, Gerresheimer
    Horst Koller, HK Packaging

    Introduction to the Interactions of Biopharmaceuticals with Pre-filled Syringes

    Interactive Session – Creating a Mind Map
    Brainstorming – Creating a Mind Map, Part I

    11:15
    Coffee Break & Exhibition

    Brainstorming – Creating a Mind Map, Part IIt
    Moderator: Alphons Fakler, Novartis

    12:30
    Lunch & Exhibition

    Interactions of Biopharmaceuticals in Pre-filled Syringess

    • Advantages and Challenges of Different Materials
    • Viscosity of Products
    • Usability for Patients
    • Risk Analyses
    • Case Studies and Real-Life Experience from Patients, Suppliers and Industry

    Q&A, Discussion

    15:15
    Coffee Break & Exhibition

    Workshop Summary
    Interactive Summary of the Workshop

    17:00
    End of Workshop & Farewell
    William Dierick, Terumo
    Philippe Lauwers, Terumo
    Roman Mathaes, Lonza
    Wenzel Novak, Gerresheimer
    Bernd Zeiss, Gerresheimer
    Horst Koller, HK Packaging

Highlighted Speakers

Philippe Lauwers
Philippe Lauwers
Terumo

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    Professionals involved in research, development and manufacturing of biopharmaceuticals, primary drug container and parenteral drug device development, quality and regulatory.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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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.

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden

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  • Accommodations

    The Swedish Exhibition & Congress Centre Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg, Sweden

    Hotel Accommodation

    optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. 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.

    You can book your Hotel Accomodation here!
  • Amenities

How to Get Here

By Air

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By Car

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Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €795

All fees given in Euro and excluding VAT (25%)

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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  • Nadjeschda Gomez-Stahl
    Manager, Exhibition & Sponsorship

    gomez@pda.org

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