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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Taiwan Conference

Nov 06 - Nov 07, 2018 |
Nov 07, 2018 |
Regent Taipei | Taipei, Taiwan
  • Chapter
  • Conference
  • Western Hemisphere Events
  • Asia-Pacific
Exhibition: November 6-7
Courses: November 8-9
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The 2018 PDA Taiwan Conference will kick off with an update on  recent changes to regulations, focusing on the proposed revision to Annex 1 and other regulations relevant for parenteral packaging. 

The Conference will concentrate on primary packaging components, devices, and fill-finish procedures. Relevant tests, such as visual inspection, container closure integrity, and extractables and leachables, will also be covered. A special session will address the use of electronics for pharmaceutical applications. 

This Conference will go beyond the technical aspects of pharmaceutical manufacturing, with a special session devoted specifically to business-related aspects of the industry. In this session, critical considerations regarding such areas as marketing and the challenges of developing successful partnerships, especially for the manufacture of biotech/biosimilar products, and what needs to be in place for successful partnerships, will be addressed. And, hear directly from the experts how patient-friendly injection systems may impact market success. 

The Conference agenda incorporates panel discussions and plenty of time for the presenters to answer your questions. An exhibition will highlight new products and services.

Plan to stay on after the Conference to take part in several training courses that will take a more in-depth look at some of the topics covered during the Conference.

Tuesday, 6-November

8:00 – 17:00
Registration Open

9:00 – 10:15
P1: Opening Plenary
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA Europe

9:00 – 9:05
Welcome and Opening Remarks: Welcome by the Chapter President of Taiwan
Lain-Tze Lee, Industrial Technology Research Institute

9:05 – 9:30
The Evolving Pharma Outlook on Primary Containers and Injection Devices: History, Status Quo, and Trends
Mathias Romacker, Senior Director, Device Strategy/Marketing, Pfizer, Inc.

9:30 – 9:55
Biosimilar Products Differentiated by Drug Delivery Devices
Robin Hwang, Owner, ICP Consulting Corp.

9:55 – 10:15
Questions and Answers/Discussion

10:15 – 10:45
Refreshment Break in Exhibit Area

10:45 – 12:30
P2: Regulatory Updates
Moderators: Mathias Romacker, Senior Director, Device Strategy/Marketing, Pfizer, Inc.

10:45 – 11:05
Taiwan FDA Representative Invited

11:05 – 11:25
U.S. FDA Representative Invited

11:25 – 11:55
Julia Yeh, Senior Manager, Device Regulatory, Amgen, Inc.

11:55 – 12:15
Industry Representative Invited

12:15 – 12:30
Questions and Answers/Discussion

12:30 – 13:30
Networking Luncheon

13:30 – 15:00
Concurrent Sessions

Track A: Primary Packaging Components
Moderator: Gabriele Peron, Senior Marketing Advisor, Stevanato Group

13:30 – 14:00
Alessandro Morandotti, Product Manager Syringes, OMPI

14:00 – 14:30
Industry Representative Invited

14:30 – 15:00
Questions and Answers/Discussion

Track B: Manufacturing
Moderator: Robin Hwang, Owner, ICP Consulting Corp.

13:30 – 14:00
Flexible and Modular Facilities
Dennis Powers, Director of Sales Engineering, G-CON Manufacturing

14:00 – 14:30
Current Best Practice in Bioburden Control
James N. Polarine, Jr., MA, Senior Global Technical Service Manager, STERIS Corporation

14:30 – 15:00
Questions and Answers/Discussion

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

15:30 – 17:00
Concurrent Sessions

Track A: Primary Packaging Components
Moderator: Gabriele Peron, Senior Marketing Advisor, Stevanato Group

15:30 – 16:00
Industry Representative Invited

16:00 – 16:30
Industry Representative Invited

16:30 – 17:00
Questions and Answers/Discussion

Track B: Manufacturing
Moderator: Robin Hwang, Owner, ICP Consulting Corp.

15:30 – 15:50
Changing Production Strategies in Sterile Filling
Optima

15:50 – 16:10
Bubble-Free Filling of Ready-to-Fill Cartridges
Daniel Kehl, Chief Executive Officer, Swissfillon

16:10 – 16:30
Intelligent Primary Packaging and Fill-Finish Operation
Egmont Semmler, PhD, Director R&D Pharmaceutical Fill & Finish, Groninger

16:30 – 17:00
Questions and Answers/Discussion

Wednesday, 7-November

8:00 – 15:15
Registration Open

8:30 – 10:00
Concurrent Sessions

Track A: Devices
Moderator: Magnus Fastmarken, Global Director Marketing, SHL Group

8:30 – 9:00
Autoinjectors: The Gold Standard in Self-Treatment with Biologics
Thomas Schoenknecht, PhD, Executive Director, Business Development, SHL Group

9:00 – 9:30
Pen-Injectors

9:30 – 10:00
Questions and Answers/Discussion

Track B: Testing
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA Europe

8:30 – 9:00
Trends in Container Closure Integrity Testing
Lei Li, PhD, Associate Senior Consultant Engineer, Eli Lilly and Company

9:00 – 9:30
Visual Inspection
Romain Veillon, Senior Manager, Vision Inspection, GSK

9:30 – 10:00
Questions and Answers/Discussion

10:00 – 10:30 a.m.
Refreshment Break in Exhibit Area

10:30 – 12:00
Concurrent Sessions

Track A: Devices
Moderator: Magnus Fastmarken, Global Director Marketing, SHL Group

10:30 – 11:00
Connectivity: Adding Value beyond Drug Delivery
Markus Bauss, Managing Director, SHL ConnectMeSmart, SHL Connect

11:00 – 11:30
Industry Representative Invited

11:30 – 12:00
Questions and Answers/Discussion

Track B: Testing
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA Europe

10:30 – 11:00
Extractables and Leachables
Piet Christiaens, PhD, Scientific Director, Nelson Labs

11:00 – 11:30
Device Testing
Erik Berndt, Industry Manager Medical/Pharmaceutical, Zwick

11:30 – 12:00
Questions and Answers/Discussion

12:00 – 13:00
Networking Luncheon

13:00 – 14:30
P4: Business and Marketing
Moderator: Robin Hwang, Owner, ICP Consulting Corp.

14:30 – 15:00
Refreshment Break in Exhibit Area

15:00 – 17:00
P4: Electronics, Devices, and Pharma: What is the Future?
Moderators: Mathias Romacker, Senior Director, Device Strategy/Marketing, Pfizer, Inc. and Markus Bauss, Managing Director, SHL ConnectMeSmart, SHL Connect

In the history of disease treatment, first there were pharmaceutical components only. With biological products the device became increasingly important to improve convenience for the patient. Recently there are approaches to make devices “intelligent” by integrating electronic features into the device. Potentially this will allow to improve patient`s treatment by interacting with the patient.

15:00 – 17:00
Panel Discussion with Representatives of the Ministry of Economics from Taiwan


17:00
Closing Remarks
Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA Europe

Conference Registration | November 6-7

Member

By August 27, 2018
$670

After August 27, 2018
$895

Non-member

By August 27, 2018
$895

After August 27, 2018
$1,195


Government/Health Authority/Academic

Member

By August 27, 2018
$300

After August 27, 2018
$400

Non-member*

By August 27, 2018
$300

After August 27, 2018
$400


Student

Member

By August 27, 2018
$110

After August 27, 2018
$150

Non-member*

By August 27, 2018
$110

After August 27, 2018
$150


Young Professional Member

Member

By August 27, 2018
$300

After August 27, 2018
$415


One Day Only Fee

Tuesday/Wednesday Only

Member

By August 27, 2018
$420

After August 27, 2018
$560

Non-member*

By August 27, 2018
$500

After August 27, 2018
$665

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 September 7, 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 September 7, 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.

Regent Taipei
No. 3, Ln. 39
Sec. 2 Zhongshan N. Rd.
Taipei 104, Taiwan
Phone:
+886 2 2523 8000

Rate: NT$6,200 (single)/NT$7,000++ per room per night (Deluxe King)
*Room rates are inclusive of daily breakfasts and in-room internet access and is exclusive of the 10% service charge and 5% value added tax (VAT).

Hotel Accommodations

To make reservations at the Regent Taipei, please visit the reservation page and enter Group Code SHLME1105 or call the Hotel at +886 2 2523 8000 and reference PDA Conference to receive the PDA group rate. Check in time is 15:00, and check out time is 12:00.

Amenities

Offering among the most spacious and luxurious hotel accommodation in Taipei, alongside a dazzling array of signature dining and lifestyle amenities, Regent Taipei combines the best experiences of this modern metropolis with timeless hospitality traditions. Our superb downtown location is just a short walk from the city’s main attractions and accessible via excellent transport links.

Transportation

  • If you are driving, take the Zhongshan Expressway to the Chongqing North Road interchange, turn left at Minzu East Road, continue straight ahead and turn right on Lin Sen North Road to reach the hotel.
  • During your stay, Taipei’s excellent MRT, bus, taxi and high-speed rail services make it easy to explore the city and further afield. Our hotel is conveniently located within walking distance of Zhongshan MRT station.
  • If you are interested in exhibiting at or sponsoring this event, please contact Molly Moir at moir@pda.org.
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