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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA Pre-filled Syringe Interest Group Meeting

May 10 - May 10, 2017 |
May 10, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Interest Group
  • Conference
  • Western Hemisphere Events
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With tremendous progress in the past decade, drug delivery continues to face challenges meeting the market needs of improving administration, compliance, safety, costs and accuracy; even more importantly, is taking an integrated approach to develop pre-filled syringes for tomorrow’s success assuring a positive patient experience?

New advances in materials of construction, manufacturing processes, injection processes and safety devices and other technology improvements create a dynamic environment in the drug delivery device arena. Regulatory requirements, industry experience and evolving market trends are critical considerations to ensure a complete understanding of the application of pre-filled syringes and injection devices to drug delivery. The challenges of new product introduction and support of existing products require that companies be aware of new developments.

The 2017 PDA Pre-filled Syringe IG Meeting brings together industry and regulatory experts to share their experiences, new developments, regulatory considerations, challenges and industry trends in this exciting area. The topics will benefit those looking for a basic understanding of pre-filled syringes and injection devices and those looking for a more in depth presentation of current challenges and developments.

Learning Objectives

At the completion of the meeting, attendees will:

  • Identify critical attributes of pre-filled syringe drug product development
  • Explain how innovation is helping patients to have a positive experience in managing their therapies and assuring compliance to dose regime
  • Summarize manufacturing requirements of pre-filled syringes, injection devices, safety devices and final drug/device combo products
  • Discuss quality standards, regulatory and compliance concerns
  • List insights through case studies presented by industry experts
  • Discuss market, industry trends and new technologies

Who Should Attend

Department
Business Development | Marketing | Operations | Regulatory Affairs | Manufacturing | Pharmaceutical Formulation and Process Development | Procurement | CMC | Distribution | Packaging | Quality Assurance/Control

Job Function
Manufacture of Parenteral Products | Packaging Scientists & Engineers | Stability Coordinators | Supply Chain | Logistics | Clinical Development | Business Development | Formulators | Device Engineers | Quality Engineers, Quality Professionals, Regulatory and Compliance Professionals

Contact

Jason Brown
Assistant Director, Programs
Tel: (301) 656-5900 ext. 131
Email: brown@pda.org

Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition Inquiries
David Hall
Vice President, Sales
Tel: +1 (240) 688- 4405
Email: hall@pda.org

Course Inquiries
Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151
Email: ko@pda.org

Wednesday, May 10, 2017

7:30 a.m. - 8:30 a.m.
Continental Breakfast

7:30 a.m. - 12:15 p.m.
Registration Open

8:30 am. - 9:30 a.m.
P1 - Silicone Oil: Case Studies
Moderator: Olivia Henderson, PhD Principal Engineer, Amgen, Inc., and Pre-filled Syringe Interest Group Leader

Session Description: Silicone oil is used in prefilled syringes to enable plunger motion during drug delivery. Prefilled syringes are used for many biopharmaceutical products; therefore the role of silicone oil in the immunogenicity of therapeutic proteins is an important issue. This session will discuss case studies which evaluate the effect of silicone oil in immunogenicity.

8:30 a.m. - 9:00 a.m.
Challenges in Characterization of Lubricant in Pre-Filled Syringes
Xia Dong, Principal Research Scientist, Materials & Test Methods, Eli Lilly and Company

9:00 a.m. - 9:30 a.m.
Evaluating the Relative Risk of Immunogenicity of silicone Oil droplets in Pre-filled Syringes in both In-Vitro and In-Vivo Model Systems
Nate Joh, PhD, Scientist, Amgen, Inc.

9:30 a.m. - 10:15 a.m.
Refreshment Break

10:15 a.m. - 12:15 p.m.
P2 - Quantification & Alternatives to Silicone Oil
Moderator: Akshay Kamdar, PhD, Group Leader/Associate Engineering Advisor, Eli Lilly and Company, Inc.

Session Description: This session focuses on the quantification and alternatives to silicone oil layer used as a lubricant in glass based pre-fillable syringes. Methods to quantify the silicone oil layer will be discussed along with exploring alternative technologies to silicone oil lubrication.

10:15 a.m. - 10:35 a.m.
Silicone Layer Measurements in Pre-filled Syringes
Markus Lankers, PhD, Managing Director, rap.ID Particle Systems GmbH

10:35 a.m. - 10:55 a.m.
Silicone Oil:  Do We Need or Have Alternatives?
Paolo Mangiagalli, PhD, Head of Primary Container Center of Excellence, Sanofi  

10:55 a.m. - 11:15 a.m.
Preventing Recalls and Product Complaints by Characterization and Inspecting the Lubricant Layer in Primary Packaging
Robert Schultheis, President, ZebraSci, Inc.

11:15 a.m. - 12:15 p.m.
Panel Discussion (Includes P2 presenters)
Xia Dong, Principal Research Scientist, Materials & Test Methods, Eli Lilly and Company
Nate Joh, PhD, Scientist, Amgen, Inc.

12:15 p.m. - 1:15 p.m.
Lunch

1:15 p.m. - 2:45 p.m.
P3 - Alternatives to Glass
Moderator: Carl Hitscherich, PhD, Head of Clinical Supply & External Manufacturing, Alnylam Pharmaceuticals

Session Description: This session focuses on key aspects of a prefilled syringe that need to be evaluated during dosage form development to mitigate breakage during the distribution or in administration (Manual administration or via combination product device).

2:45 p.m. - 3:30 p.m.
Refreshment Break

3:30p.m. - 4:15 p.m.
P4 - PDA and Industry Activities for Pre-filled Syringes
Moderator: Lee Leichter, President, P/L Biomedical
Session Description: This session will address current status of standards and guidance as they relate to prefilled syringes. Topics such as updates to the ISO 11040 series, including the new ISO 11040-8, Technical Report 27: Pharmaceutical Pack Integrity, and updates to Technical Report 73: Pre-filled Syringe User Requirements for Biotechnology Applications will be addressed and discussed in and open and interactive forum.

3:30 p.m. - 3:45 p.m.
Update on TR27
Olivia Henderson, PhD Principal Engineer, Amgen, Inc.

3:45 p.m. - 4:00 p.m.
Update on the 1140 Series
Lee Leichter, President, P/L Biomedical

4:00 p.m. - 4:15 p.m.
Update on TR73 Amendments
Akshay Kamdar, PhD, Group Leader/Associate Engineering Advisor, Eli Lilly and Company

4:15 pm - 5:00 pm
P4 Part 2 - Roundtable Discussion
Moderator: Olivia Henderson, PhD, Principal Engineer, Amgen, Inc.
Session Description: The last 45 minutes of the meeting provides time for attendees to pose questions, discussion topics, etc. that were not referenced during earlier portions of the meeting. In addition, any hot topics that were submitted to PDA prior to the event will be addressed.

Meeting Registration | May 10, 2017

Member

Before Mar. 17, 2017
$650

After Mar. 17, 2017
$850

Non-member

Before Mar. 17, 2017
$850

After Mar. 17, 2017
$1,050


Government/Health Authority/Academic

Member

Before Mar. 17, 2017
$300

After Mar. 17, 2017
$300

Non-member*

Before Mar. 17, 2017
$300

After Mar. 17, 2017
$300


Student

Member

Before Mar. 17, 2017
$280

After Mar. 17, 2017
$280

Non-member*

Before Mar. 17, 2017
$280

After Mar. 17, 2017
$280


All prices in US dollars.

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

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 Conference.

Multiple Meeting Discount

Receive a 10% off discount when you register for both the Pre-filled Syringe Interest Group Meeting (May 10) and the Combination Products Interest Group Meeting (May 11)!**

**Discount does not apply to Government/Health Authority/Academic rates

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may accommodate. 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 13, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. 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). If your written request in received on or before March 13, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site 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 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. Recordings are prohibited at all PDA Conferences.

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 U.S.A

From Ronald Reagan National Airport (DCA)

Take George Washington Memorial Parkway to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Metro option: Please refer to the "Public Transportation" section for details.


From Washington Dulles International Airport (IAD)

Take VA-267 E/Dulles Access Toll Road to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Bus/Metro option: Please refer to the "Public Transportation" section for details.


From Baltimore Washington International (BWI) Thurgood Marshall Airport and Points North

Take I-95 South to I-495 West (toward College Park/Silver Spring).
From I-495 West, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Bus/Metro option: Please refer to the "Public Transportation" section for details.


From the South

Take I-95 North to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.


Parking

Parking is available in the parking garage below Bethesda Towers for $12 a day. PDA does not validate parking. There are also public lots within walking distance of the facility.

Public Transportation

PDA is located on the red line at the Bethesda Metro station. Once on the street level, proceed two blocks east on East West Highway to 4350 Bethesda Towers. PDA TRI is located on the first floor.

PDA is accessible from all three airports in the area either by Metrorail, Metrobus, or both. Please see the Metro map below for details.

Metro System Map

The following hotels are conveniently located near PDA:

Hilton Garden Inn

7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
+1 (301) 654-8111

Special Hotel Rate: $192 (plus applicable taxes)

Please use the code N0033113 when making your reservation to receive the rate listed above (rates are subject to availability).


Hyatt Regency Bethesda

One Bethesda Metro Center | Bethesda, MD 20814 | 0.4 miles from PDA
+1 (301) 657-1234 / +1 (800) 233-1234 (US Only)

Special Hotel Rate: $189 (plus applicable taxes) | January-February, July-August, November-December

Special Hotel Rate: $225 (plus applicable taxes) | March-June, September-October

Please use the code 78056 when making your reservation to receive the rates listed above (rates are subject to availability).


Residence Inn Marriott Bethesda Downtown

7335 Wisconsin Avenue | Bethesda, MD 20814 | 0.4 miles from PDA
+1 (301) 718-0200

No special rates available.


DoubleTree by Hilton Hotel Bethesda

8120 Wisconsin Avenue | Bethesda, MD 20814 | 0.8 miles from PDA
+1 (301) 652-2000

No special rates available.


Hilton Rockville Hotel & Executive Meeting Center

1750 Rockville Pike | Rockville, MD 20852 | 7.0 miles from PDA
+1 (301) 468-1100

Special Hotel Rate: $169 (plus applicable taxes)

Please use the code N2703011 when making your reservation via phone. Rates are subject to availability.

There will be high profile, cost-effective sponsorship opportunities available to a very limited number of companies. To secure your sponsorship, please contact David Hall, hall@pda.org, Tel: +1 (240) 688-4405.

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3659

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