2018 PDA Biopharmaceuticals Conference

Seoul, Korea
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Program Highlights

Registration is still available onsite at the Conference!

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!

Event Location
Imperial Palace Seoul
640 Eonju-ro, Nonhyeon-dong, Gangnam-gu, Seoul, Korea Get Directions

Contact

Program Inquiries
Tel: +1 (301) 656-5900
Exhibition/Sponsorship Inquiries
David Hall
Tel: +1 (240) 688-4405
Training Course Inquiries
Tel: +1 (301) 656-5900
Registration Customer Care
Tel: +1 (301) 656-5900

More information coming soon.

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.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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].

Day 1

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

Agenda is subject to change.

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.

Imperial Palace Seoul

640 Eonju-ro, Nonhyeon-dong, Gangnam-gu
Seoul, Korea ,
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.

Imperial Palace Seoul
640 Eonju-ro
Nonhyeon-dong
Gangnam-gu
Seoul, Korea 06098
Tel: 82 2 3440 8000
Website

Rate: KRW 160,000++ - Guestroom rate includes (1) breakfast and internet access and is subject to 10% service charge and 11% government tax each night. 

Amenities

Imperial Palace Seoul features luxurious European styling and the latest in technology to offer a comfortable and convenient place to work and rest. Imperial Palace Seoul is located in the heart of the business and cultural center, Seoul, South Korea’s thriving capital, and it has long been a city landmark. A noble and artistic atmosphere with elegant European style interior, antiques and paintings, Imperial Palace Seoul provides a space to enjoy beautiful art beyond the function of accommodation by offering the best service and giving top priority to customer satisfaction and impression under the motto of ‘The Best of Everything’. Developing its 26-year history with pure domestic capital as the best hotel brand with a world class network along with ‘Imperial Palace City Hotel Fukuoka’ in Japan in 2007 and ‘Imperial Palace Boutique Hotel’ in Itaewon, Korea in early 2010.

Renowned ‘close service’ of Imperial Palace Seoul valuing customer satisfaction first has been improved through a service training program (A.S.S.A) since 1996. The hotel has tried to provide satisfactory service to guests through seat-style front desk, one-to-one escort service from front to guestroom, knee service at restaurants, and free valet parking service for women.

Airport

Incheon International Airport (ICN) is located 65 km (approx. 1 hour) from Imperial Palace Seoul.