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2018 PDA Biopharmaceuticals Conference

Apr 17 - Apr 18, 2018
Seoul, Korea

From Drug Substance Manufacturing to Final Product

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Program Highlights

Registration is still available onsite at the Conference!

Overview

The Program Planning Committee, PDA’s Korea Chapter, and PDA invite you to participate in an exciting Conference, 2018 PDA Biopharmaceuticals Conference, Apr. 17-18 in Seoul, Korea.

The goal of this Conference is to give a broad overview on biopharmaceuticals, focusing on important aspects of drug substance and drug product. Topics to be covered include:

  • Update on regulations and regulatory inspections
  • Facility concepts for pharmaceutical manufacturing processes
  • Single-use systems and next-generation processing
  • Contamination control clean rooms and aseptic areas
  • Aseptic processing and fill-finish operations
  • IPCs and final product testing
  • Primary packaging and devices especially for biopharmaceuticals, including the relevant test procedures

Industry and regulatory experts will  discuss trends in the biopharmaceutical field, and the regulatory and technical impact of these trends will be detailed. The challenges of commercialization of biosimilars in a competitive global environment will also be addressed.

Presentations will focus on practical technological aspects, using case studies as examples. There will also be a an exhibition showcasing the latest in equipment and services.

Throughout the Conference, there will be plenty of time for questions and in-depth discussion, as well as networking opportunities with experts and colleagues.

To further your learning experience, immediately after the Conference, PDA will host training courses on cleaning and disinfection, primary packaging, and devices.

We are looking forward to seeing you in Seoul!

Agenda

  • Tuesday, April 17

    8:00 – 18:30 | Registration Open

    9:00 – 10:30 | P1: Opening Plenary: Regulatory Updates
    The pharmaceutical industry is a regulated industry; therefore, assessors and inspectors of health authorities are important partners of the industry. This session will address the draft EU/PIC/S Annex 1 and international regulatory developments.

    Moderator: Georg Roessling, PhD, Senior Consultant, Business Development, PDA

    9:00 | Welcome and Opening Remarks
    Woo-Hyun Paik, PhD, President, PDA Korea Chapter

    9:15 | Current Issues on GMP Inspections and the New Annex 1
    Regulatory Representatives Invited

    9:45 | Process Validation – A New Perspective: Updates from PDA TR42: Process Validation of Biopharmaceutical Drug Substance Manufacturing
    Udesh de Silva,
    Lead Scientist, Samsung Biologics
     
    10:15 | Questions and Answers/Discussion

    10:30 – 11:00 | Refreshment Break in Exhibit Area

    11:00 – 13:00 | P2: Trends in Biopharmaceuticals
    This session will describe the current environment of biopharmaceuticals from a research and development, manufacturing, and regulatory perspectives. Innovator products and biosimilars, make or buy: what are technical and commercial challenges and what options are possible.

    Moderator: Georg Roessling, PhD, Senior Consultant, Business Development, PDA

    11:00 | Trends in Biopharmaceuticals: Impact on Drug Development and Commercialization
    Marie-Liesse Le Corfec, Director, Global Marketing, PFS, BD

    11:30 | Data Integrity Integration and the Power of ALCOA
    Nick Beaumont, MBA, Vice President, Quality and Compliance, Samsung Biologics

    12:00 | Pharmaceutical Facilities: Flexibility by Design Options for Incorporating Flexibility in the Conceptual Design Phase
    Morten Munk, Global Technology Partner, NNE

    12:30 | Questions and Answers/Discussion

    13:00 – 14:00 | Networking Luncheon

    14:00 – 16:00 | P3: Single-Use Systems (SUS) and Their Role in Manufacturing
    This session will give an overview of PDA Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing and gives practical examples on how to make use of SUS and what challenges need to be considered. From vendor to user, physical and chemical properties; in use tests.

    Moderator: Nick Beaumont, MBA, Vice President, Quality and Compliance, Samsung Biologics

    14:00 | PDA Technical Report on Single-Use Systems
    Morten Munk, Global Technology Partner, NNE

    14:30 | Next Generation Technologies to Support Downstream Process Intensification
    Takao Ito, Head of Manufacturing Sciences & Technology (MSAT) Japan and Korea, Process Solutions, Merck Ltd, Japan

    15:00 | Extractables and Leachables: What Needs to be Considered When Using SUS
    Karen Pieters, Team Responsible Extractables and Leachables, Nelson Laboratories, LLC

    15:30 | Questions and Answers/Discussion

    16:00 – 16:30  | Refreshment Break in Exhibit Area

    16:30 – 18:30 | P4: Aseptic Processing and Fill Finish Operations
    The session will address the environment and equipment of aseptic processing and manufacturing. After starting with challenges of bacterial contamination and the avoidance by proper cleaning and disinfection the session will next address the technical and methodical solutions of fill finish operations. Presentations will also address the latest developments and approaches to qualify filling lines with high flexibility and short change-over times. Concepts regarding bulk primary packaging and ready-to-use containers, highly modular lines in barrier systems for liquid, and freeze-dried products will be presented.

    Moderator: Morten Munk, Global Technology Partner, NNE

    16:30 | Fungal and Bacterial Spore Excursion: Case Studies
    Jim Polarine, MA, Senior Technical Service Manager, STERIS Corporation

    17:00 | Challenges and Solutions to Fill Biopharmaceuticals
    Markus Hoersch, Sales and Marketing Director, Bausch + Ströbel

    17:30 | Case Study: Multi-Format Flexible Filling Line Isolator for All Containers – Design, Workflow, and Validation Approach
    Sergio Mauri, MSc, Director, Marketing and Business Intelligence, Fedegari Group

    18:00 | Questions and Answers/Discussion

    Wednesday, April 18

    7:30 – 17:00 | Registration Open

    8:00 – 10:00 | P5: IPC and Final Product Testing
    A manufacturing process and a fill finish operation should be validated with in-process controls which ensure that the process leads to a reliable quality which meet a specification. The presentations in this session will address methods on container closure integrity and applications of head space analytics. Methods which are preferable quantitative, fast and reliable.

    Moderator: Markus Hoersch, Sales and Marketing Director, Bausch + Ströbel

    8:00 | Material Transfer into RABS and Isolators
    Matthias Angelmaier, Product Management Pharma Liquid (PA-PH/PRM12), Robert Bosch Packaging Technology GmbH

    8:30 | CCIT Technology and 100% Inspection Supporting USP <1207>
    Jaime Cobo Vélez, Sales and Marketing Director, Wilco AG

    9:00 | Head Space Applications in Pharma
    Derek Duncan, PhD, Director and Vice President, Marketing, LIGHTHOUSE Instruments

    9:30 | Questions and Answers/Discussion

    10:00 – 10:30  | Refreshment Break in Exhibit Area

    10:30 – 12:30 | P6: Primary Packaging
    Primary packaging is an essential part of a pharmaceutical product; it is needed to ensure quality of the product over shelf life but also the type of container (vial, syringe cartridge or ampoule) is important for the convenience of patient use. Two presentations will address what needs to be considered when filling especially biopharmaceutical products. As materials there are glass and polymer available.

    Moderator: Thomas Schoenknecht, PhD, Executive Director, Business Development, SHL Group AB

    10:30 | How to Mitigate and Control Biodrug Challenges for Glass Primary Packaging: A Manufacturing Approach
    Alessandro Morandotti,Product Manager, Ompi – Stevanato Group

    11:00 | Polymer-based prefillable syringes designed to minimize the aggregation risk of sensitive biodrugs
    Philippe Lauwers, Director, Technology Development, Terumo Europe N.V.

    11:30 | Silicone Oil-Related Challenges for Biopharmaceuticals and Potential Solutions
    Sebastien Jouffray, Director, R&D, PDL, BD

    12:00 | Questions and Answers/Discussion

    12:30 – 13:30  | Networking Luncheon in Exhibit Area

    13:30 – 15:00 | P7: Devices
    Most modern biopharmaceuticals use pre-filled syringes or cartridges, which are assembled in a device, autoinjector, pen system, or more sophisticated system (e.g., for freeze-dried products). The presentations in this session will address the tests to be performed to ensure a successful and reliable assembly of primary container and device. Development strategies for devices and technical challenges for a successful introduction into the market will also be discussed. Finally, advantages for patients using devices will be highlighted, especially focusing on the very competitive environment for biosimilars.

    Moderator: Tony Ye, MA, Business Director, BD

    13:30 | How to Test Primary Containers and Assembled Devices for Parenteral Drug Delivery
    Erik Berndt, Industry Manager, Medical/Pharmaceutical, Zwick GmbH & Co KG

    14:00 | Device Development and Lifecycle Management In Modern Drug Delivery: Options To Differentiate with A Market-Accepted Platform
    Thomas Schoenknecht, PhD, Executive Director, Business Development, SHL Group AB

    14:30 | Questions and Answers/Discussion

    15:00 – 15:30 | Refreshment Break in Exhibit Area

    15:30 – 17:15 | P8: Product Development with a Pre-Filled Syringe
    For modern biopharmaceutical products it is most important to consider aspects of patient convenience of the drug application. This should be considered as part of the development and life cycle management of the drug. This session will give examples about what and how it can be achieved. 

    Moderator: Thomas Schoenknecht, PhD, Executive Director, Business Development, SHL Group AB

    15:30 | Product Development with a Pre-Filled Syringe
    Michael Vetter, Strategic Market Development, Vetter Pharma International GmbH

    16:00 | Competitive Advantage for Biosimilars through Combination Products and Lifecycle Management
    Tony Ye, MA, Business Director, BD

    16:30 | Questions and Answers/Discussion

    17:00 | Closing Remarks from Conference Chair
    Georg Roessling, PhD, Senior Consultant, Business Development, PDA


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:


    Type of Activity:

    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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Registration Fees

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* 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).

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REFUND: If a refund request is sent by , a full refund will be given minus a $200 fee. After , 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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Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

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