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Global Event Calendar

 
2019 ParPack

Parenteral Packaging

Mar 19 - Mar 20, 2019
Venice, Italy

Interaction of Product, Package, and Process

  • Conference
  • Europe

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Program Highlights
Join us in Venice, Italy in March 2019 for innovation highlights and more when we discuss all about the Interaction of Product, Package, and Process!

Overview

Dear Colleague,

Primary packaging of pharmaceutical dosage forms should be designed, manufactured, processed and assembled in a way that does not alter the safety, identity, strength, quality or purity of the drug product beyond the established requirements. With complex forms of pharmaceuticals such as biologics entering the market, special requirements for handling, storage and packaging need to be met. Different materials such as glass and their characteristics regarding supplier issues, interactions with the drug product and end-user preferences will be discussed as well as the latest regulatory updates such as the Annex 1 of the European GMP Guideline and USP 800. Topics to be explored will further include some of the latest developments in packaging materials & components and the role of Container Closure Integrity (CCI) in product-package development, assembly and processing. The week’s program of the 2019 PDA Europe Parenteral Packaging conference is intended to initiate and support discussion and professional exchange through a diversity of scientific presentations, workshops, training courses, joint dinners and networking events.

We look forward to you joining us in amazing Venice!

Sincerely,
The Co-Chairs

Roger Asselta, Genesis Packaging Technologies
Roman Mathaes, Lonza

Agenda

  • Day 1
  • Day 2
  • Tuesday, 19 March 2019

    9:00 – 9:15
    Welcome and Introduction
    Kertin Wilken, PDA Europe
    Roger Asselta,, Genesis Packaging Technologies
    Roman Mathaes, Lonza

    OPENING PLENARY

    9:15 – 9:45
    Keynote: The Evolution of Parenteral Drug Substance and Drug Product Primary Containers
    Karthik Vaideeswaran, Eli Lilly

    9:45 – 12:45
    Session 1: Packaging Considerations for Cold Storage
    Moderator: Derek Duncan, LIGHTHOUSE

    9:45 – 10:15
    Primary Container Design for Drug Substance at Cryo- and Cold Temperatures
    Ronald Iacocca, Eli Lilly

    10:15 – 10:45
    Q&A, Discussion

    10:45 –11:15
    Coffee Break, Poster Session & Exhibition

    11:15 – 11:45
    Nonlinear Finite Element Simulation of Frozen Container Closure Systems
    Holger Roehl, Roche

    11:45 – 12:15
    Case Study: Ensuring Container Closure Integrity of a Gene Therapy Cancer Vaccine in Need of Deep Cold Storage
    Josine Wilmer, LIGHTHOUSE

    12:15 – 12:45
    Q&A, Discussion

    12:45 –14:00
    Lunch Break, Poster Session & Exhibition

    PARALLEL TRACKS

    14:00 – 15:40
    Session 2A: Glass
    Moderator: Claudia Heinl, SCHOTT

    14:00 – 14:20
    Delamination in Glass Containers for Pharmaceutical Application: The International Commission on Glass (ICG) Technical Committee TC12
    Massimo Guglielmi, University of Padova

    14:20 – 14:40
    Next Generation of Primary Packaging
    Robert Hayes, Gerresheimer

    14:40 – 15:00
    A Case Study for Mitigation of Visual Particulate in Glass Ready-to-Use Vials
    Anthony Vico, Stevanato Group
    Elizabeth Jane Pavlik, MSD

    15:00 – 15:20
    New Parenteral Glass Packaging Option May Lead to Reduction in Particulates and Ultimately Drug Shortages
    Kyle Hoff, Corning

    15:20 – 15:40
    Q&A, Discussion

    14:00 – 15:40
    Session 2B: Manufacturing in the Digital Age
    Moderator: Bettine Boltres, WEST

    14:00 – 14:20
    Identification and Quantification: Multisensor Drone Technology
    Fabian Thygs, Janssen J&J

    14:20 – 14:40
    Comprehensive Container Closure System (CCS) Stack-up Simulation and Optimization in the Digital Age
    Anthony Bucci, WEST

    14:40 – 15:00
    Testing and Computational Modelling in the Study of Cartridge Failure
    Daniela P. Boso, University of Padova

    15:00 – 15:20
    Quantifying the Vial Capping Process Using Micro-Computed Tomography
    Robert Ovadia, Genentech

    15:20 – 15:40
    Q&A, Discussion

    15:40 – 16:10
    Coffee Break, Poster Session & Exhibition

    16:10 – 18:00
    Session 3A: Considerations on Container Closure Integrity
    Moderator: Roger Asselta, Genesis Packaging Technologies

    16:10 – 16:40
    Balancing Container Closure Integrity and Aesthetics for Robust Primary Packaging
    Yusuf Oni, Bristol-Myers Squibb

    16:40 – 17:10
    Container Closure Integrity Testing – Method Development for Freeze- Dried Products Using Laser-based Headspace Oxygen Analysis
    Søren Dahl, Novo Nordisk
    Jonas Olsen Hede, Technical University of Denmark

    17:10 – 17:40
    Interlaboratory Study of Container Closure Integrity He-leak Test Method - Comparison of Different Types of Artificial Leaks
    Klaus Wuchner, Janssen J&J
    Daniel Wagner, Sanofi

    17:40 – 18:00
    Q&A, Discussion

    16:10 – 18:00
    Session 3B: Chemical Interactions of Drug Product and Primary Packaging
    Moderator: Galen Shi, Eli Lilly

    16:10 – 16:40
    The Advantages of Considering Primary Container Systems as an Excipient During Formulation Development
    Cathy Zhao, WEST

    16:40 – 17:10
    Comparative Leachable Study for Glass Vials to Demonstrate the Impact of Low Fill Volume
    Volker Rupertus, SCHOTT

    17:10 – 17:40
    Interactions of Leachables with Proteins: Combined In-Silico and Experimental Model to Monitor the Potential Impact on Quality and Safety of Therapeutic Proteins
    Piet Christiaens, Nelson Labs

    17:40 – 18:00
    Q&A, Discussion

    18:00
    End of Day 1 and Networking Event

  • Wednesday, 20 March 2019

    9:00 – 9:30
    Keynote: Keynote: Getting Ready for Annex1 and USP 800
    Roman Mathaes, Lonza
    Hanns-Christian Mahler, Lonza

    9:30 – 11:30
    Session 4: Regulatory Updates
    Moderator: Andrea Salmaso, Stevanato Group

    9:30 – 10:00
    Chinese Regulatory Update
    Yonghua Gao, CNPPA

    10:00 – 10:30
    USP Chapter Changes on Glass and Rubber
    Bettine Boltres, WEST

    10:30 – 11:00
    ISO Standard Series ISO 11040 on Pre-filled Syringes, Updates on ISO Technical Committees TC76 and TC84
    Horst Koller, HK Packaging

    11:00 – 11:30
    Q&A, Discussion

    11:30 – 12:00
    Coffee Break, Poster Session & Exhibition

    PARALLEL TRACKS

    12:00 – 13:00
    Session 5A: Challenges in Development & Manufacture
    Moderator: Renaud Janssen, Datwyler

    12:00 – 12:25
    A Quality by Design Approach Toward Manufacturing of Elastomeric Components for Parenteral Packaging Applications
    Rahul Thakar, Datwyler

    12:25 – 12:50
    Multi-Chamber IV Bag Film Development
    Silvio Gianoli, Sealed Air Corporation

    12:50 – 13:00
    Q&A, Discussion

    12:00 – 13:00
    Session 5B: Sterilization of Packaging
    Moderator: Joerg Zuercher, Bayer

    12:00 – 12:25
    Validation of VH2O2 Sterilization Process per ISO14937
    Juha Mattila, STERIS

    12:25 – 12:50
    Alternative Sterilization Techniques for Elastomeric Components for Primary Packaging
    Bram Jongen, Datwyler

    12:50 – 13:00
    Q&A, Discussion

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

    CLOSING PLENARY

    14:00 – 16:30
    Session 6: Primary Packaging & Development Considerations
    Moderator: Roman Mathaes, Lonza

    14:00 – 14:30
    Factors Influencing Quality of Biopharmaceuticals in Pre-filled Syringes
    Susumu Uchiyama, Osaka University

    14:30 – 15:00
    Lyophilization in Pre-filled Syringes: Evaluating the Influence of Primary Container Material and Loading Device
    Timothy Dutill, Lyophilization Technologies
    Kevin Constable, Terumo

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

    15:30 – 16:00
    Quality of Components & Containers – Design, Materials, New Technologies
    Robert Hormes, Novartis

    16:00 – 16:30
    Q&A, Discussion

    16:30
    End of Conference & Farewell
    Kertin Wilken, PDA Europe
    Roger Asselta,, Genesis Packaging Technologies
    Roman Mathaes, Lonza

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

Make a Reservation
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 to the Conference Venue
Distance: 17 km

Airport shuttle service
Hotel Station
: Giudecca Stucky

  • Public Boat: approx. €15 per passenger (one way)
Water Taxi Info

Directions

Registration Fees

Early Registration
Registration Type Price by 03 February
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €750





Regular Registration
Registration Type Price after 03 February
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €850

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.

Special Dietary Requirements

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).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

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 [email protected]. Phone messages are not accepted.

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Contact

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Tel: +1 (301) 656-5900 ext. 115
[email protected]