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2019 ParPack

Interest Group Meeting Pre-filled Syringes

Mar 18, 2019
Venice, Italy

Time-to-Market – Novel Approaches to Supporting the Patient by Reducing Pre-Filled Syringe Development Timelines

  • Interest Group
  • Europe
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Program Highlights

Take advantage of the open forum design offered by the small Interest Group meeting approach. Hear presentations from renowned international experts, interact and discuss your experiences with colleagues in round table discussions and forums during the meeting.
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Overview

Dear Colleagues,

Time-to-market is gaining in importance, especially since the industry wants to support patients with new drugs as quickly as possible. Unfortunately, the costs associated with new injectable drug products continue to increase over time. Minimizing development time also presents challenges. In fact, every day added to the development plan actually diminishes the value for licensing or selling of the drug product due to reductions in potential revenue and market exclusivity.

The goal of this meeting is to discuss these challenges with a primary focus on:

  • Approaches and trends in drug development with the potential to rapidly support
    patients with new drugs.
  • Time-to-market packaging platforms, new technologies, regulation strategies, clinical and commercial fill & finish, secondary packaging, etc.
  • Case studies from a pharma/biotech supplier using tools, platforms or methods,
    supplier solutions, process and technology infrastructure, and development strategies that demonstrate a reduction in time-to-market.

Take advantage of the open forum design approach offered by this focused Interest Group meeting. Hear presentations from leading experts and interact and discuss your experiences with colleagues in an open atmosphere.

Share your opinion and enlarge your knowledge in an interactive format discussion. Receive the latest information about activities of the Interest Group/Pre-filled Syringes.

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Agenda

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  • Monday, 18 March 2019

    10:00
    Welcome and Introduction

    Falk Klar, PDA Europe
    Brigitte Reutter-Haerle, Vetter

    10:10 – 12:00
    Innovations to Shorten Time to Market
    Moderator: Brigitte Reutter-Haerle, Vetter

    Due to reductions in potential revenue and market exclusivity, every day added to the development plan diminishes the value for licensing or selling of the drug product. In this session, leading experts discuss platform technologies as well as new technologies and methods that demonstrate how a reduction in time-to-market can be achieved.

    10:10 – 10:35
    Accelerating Time-to-Market of Smart Devices: How to effectively upgrade self-injection device platforms into integrated cloud-connected systems
    Andreas Schneider, Ypsomed

    10:35 – 11:00
    Switch from High Speed Line to Flexible Tabletop and/or Manual Assembly in Packaging with the Goal to Shorten Time to Market
    Guido Drees, Roche

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

    11:30 – 12:00
    Root Cause Investigation on a Drug Formulation Interacting with Silicone Oil Resulting in Extended Injection Time Using an Auto-injector Device
    Robert Hormes, Novartis

    12:00 – 13:00
    Lunch Break, Poster Session & Exhibition

    13:00 – 14:30
    Interactive Session - Innovations to Shorten Time to Market
    Moderator: Frank Bamberg, Roche

    After parting in 3 groups the participants will enter a structured conversational process regarding Risks and Challenges, Technical Solutions and Partnerships and Cooperation in three rounds. Facilitated by a table moderator each group is introduced to the topic and will have a set amount of time to discuss and gather key points on each topic. As each group will build on the knowledge already gathered each round will be shorter than the prior. Inspired by the method developed by Juanita Brown und David Isaacs this session will result in conclusive take-home-messages on each topic discussed.

    13:00 – 13:10
    Introduction
    Frank Bamberg, Roche

    13:10 – 13:15
    Transition to 3 Groups
    Risks and Challenges, Moderator: Michael Betz, Roche
    Technical Solutions, Moderator: Gabriele Peron, Stevanato Group
    Partnerships and Cooperation, Moderator: Andreas Schneide, Ypsomed

    13:15 – 13:35
    Round 1

    13:35 – 13:50
    Round 2

    13:50 – 14:00
    Round 3

    14:00 – 14:30
    Summary

    14:30 – 15:00
    Coffee Break, Poster Session & Exhibition

    15:00 – 16:30
    Novel Approaches & Practical Implementations
    Moderator: Philippe Lauwers, Terumo

    15:00 – 15:25
    Track and Trace of Primary Packaging Containers – A discussion on the Fill & Finish operations for single containers
    Bernd Zeiss, Gerresheimer
    Riccardo Marcon, Stevanato Group
    Diana Löber, Schott
    Chi Yuen Liu, Johnson & Johnson

    15:25 – 15:50
    Modular Robotic Inspection - fully automated inspection with an autonomous island mini-plant.
    Andrea Sardella, Stevanato Group
    Michael Betz, Roche

    15:50 – 16:15
    Roadmap to Create a Global Presence in Aseptic Injectable Fill & Finish from a Development Capability to Full Scale Commercial Expansion: A Corden Pharma Case History
    Silvia Lissoni, Corden Pharma

    16:15 – 16:30
    Summary and Q&A

    16:30
    RConclusion of Interest Group Meeting
    Brigitte Reutter-Haerle, Vetter

Highlighted Speakers

Brigitte Reutter-Haerle
Brigitte Reutter-Haerle
Vetter Pharma International GmbH

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • 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.

Hilton Molino Stucky Venice

Giudecca 810
Venice, Italy
Phone: +39 041 272 3311

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Hilton Molino Stucky Venice
  • Accommodations
    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
  • Amenities

How to Get Here

By Air

Nearest Airport: Venice Marco Polo Airport – VCE

Airport Phone: +39 041 260 9260

By Car

More information coming soon.

Other Options

Transfer per Public Boat (Linea Blu timetable) to the Conference Venue
Distance: 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)
Water Taxi - Hilton Venice

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €350

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

* 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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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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Tel: +1 (301) 656-5900 ext. 115
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