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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Biopharmaceuticals Conference

From Drug Substance Manufacturing to Final Product
Apr 17 - Apr 18, 2018 |
Apr 18, 2018 |
Imperial Palace Seoul | Seoul, Korea
  • Conference
  • Western Hemisphere Events
  • Asia-Pacific
Exhibition: April 17-18
Courses: April 19-20
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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!

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 (Invited)

9:15 | Representatives of Health Authorities Share Their Perspectives on The Current Issues on GMP Inspections and New Regulations
Regulatory Representatives Invited

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
Christian Herget, PhD, Global Business Director, BD (Invited)

11:30 | Manufacturing of Biopharmaceuticals: A CDMO Perspective
Nick Beaumont, MBA, Vice President, Quality and Compliance, Samsung Biologics (Invited)

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

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 (Invited)

14:00 | PDA Technical Report on Single-Use Systems
Industry Representative Invited

14:30 | Next-Generation Processing of Biopharmaceuticals
Sandra Hon, Senior Marketing Specialist, Merck Millipore (Invited)

15:00 | Extractables and Leachables: What Needs to be Considered When Using SUS
Piet Christiaens, PhD, Scientific Director, Toxikon Europe – a Nelson Labs/Sotera Health Company (Invited)

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 (Invited)

17:00 | Flexible and Modular Production System
Markus Hoersch, Sales and Marketing Director, Bausch + Ströbel (Invited)

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 (Invited)

18:00 | Questions and Answers/Discussion

Wednesday, April 18

8:00 – 17:15 | Registration Open           

8:30 – 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 (Invited)

8:30 | CCIT Technology and 100% Inspection Supporting USP <1207>
Jaime Cobo, Wilco (Invited)

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

9:30 | Questions and Answers/Discussion

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

10:30 – 12:00 | 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 (Invited)

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

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

11:30 | Silicone Oil-Related Challeneges for Biopharmaceuticals and Potential Solutions
Christian Herget, PhD, Global Business Director, BD (Invited)

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 (Invited)

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

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 (Invited)

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 (Invited)

15:30 | Product Development with a Pre-filled Syringe
Julia Rieger, Vetter Pharma International GmbH (Invited)

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

16:30 | Questions and Answers/Discussion

17:00 | Closing Remarks from Conference Chair

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

Conference Registration | April 17-18

Member

$1,195

Non-member

$1,495


Government/Health Authority

Member

$530

Non-member*

$530


Academic

Member

$530

Non-member*

$530


Student

Member

$200

Non-member*

$200


Young Professional Member

Member

$598


One Day Only Fee

Tuesday/Wednesday Only

PDA Member
$800

Nonmember
$950

All prices in US dollars.

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

You must be a member to take advantage of this rate.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

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

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by March 1, 2018 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference, Workshops and Events: If your written request in received on or before March 1, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences.

Imperial Palace Seoul
640 Eonju-ro
Nonhyeon-dong
Gangnam-gu
Seoul
Korea 06098

Tel: 82 2 3440 8000

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. 

Website: https://www.imperialpalace.co.kr/eng/

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.

The 2018 PDA Biopharmaceuticals Conference will provide your company the premier opportunity to gain access to key decision makers from the biopharmaceutical science and manufacturing industry. Become a sponsor and/or exhibit at the 2018 PDA Biopharmaceuticals Conference to connect with industry thought leaders, strengthen your brand image, increase your visibility, and show your company’s strong commitment to the industry.

We are happy to create a unique sponsorship or exhibit opportunity for you!

Molly O’Neill Moir, CMP
Vice President, Programs & Meetings
P: +1 301 656 5900 x 132
E: moir@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4177

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