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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Universe of Pre-Filled Syringes and Injection Devices

Transforming Pre-Filled Systems through Innovation
Oct 08 - Oct 09, 2018 |
Oct 09, 2018 |
Loews Royal Pacific | Orlando, FL
  • Conference
  • Western Hemisphere Events
Exhibition: October 8-9
Post-Workshop: October 10
Courses: October 11-12
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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. Only through an integrated approach to developing pre-filled syringes and injection devices can we be successful in delivering a successful product that delivers 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 2018 PDA Universe of Pre-Filled Syringes and Injection Devices 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 as well as those looking for a more in-depth presentation of current challenges and developments. This is a must-attend event for all industry professionals involved in the development, manufacturing, marketing, or use of pre-filled syringes and injection devices.

Sessions will cover topics such as:

  • Quality Infrastructure and Issues
  • New Technologies and Trends in Manufacturing Processes
  • Case studies
  • Human Factors/Usability
  • Injection Devices: Critical Attributes and Risk Management
  • Regulatory and Compliance Aspects of Combination Products
  • New primary Containers, Safety Devices, and Delivery Systems
  • The move toward “Smart Devices”
  • Global Market Trends

Learning Objectives

At the completion of this conference, attendees will:

  • Discuss the market benefits of pre-filled syringes and injection devices
  • Identify critical attributes of end-user friendly devices
  • 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

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


Conference Inquiries
Jason E. Brown

Assistant Director, Programs
Tel: +1 (301) 656-5900 ext. 131

Registration Inquiries
Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115

Exhibition Inquiries
David Hall

Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160

Sunday, October 7

4:00 p.m. - 7:00 p.m. 
Registration Open

Monday, October 8

7:00 a.m. - 5:15 p.m. 
Registration Open

7:15 a.m. - 8:15 a.m. 
Continental Breakfast

8:15 a.m. - 8:30 a.m. 
Welcome and Opening Remarks from Planning Committee Co-Chair
David Haase, Senior Manager, Device Development, Genentech, Inc.

8:30 am. - 10:00 a.m. 
P1: Drug Delivery Innovations that Bring Value to both the Patient and the Business
Moderator: David Haase, Senior Manager, Device Development, Genentech, Inc.

Innovations are exciting and bring new capabilities, but they may also bring added costs. In this session we will focus on a few of the recent connected device innovations and see how they bring not only value to the patient but also bring real returns to the business. We will explore the Patient, the Pharma, the Payer and the Health care Provider perspectives.

9:45 a.m. - 5:15 p.m.
Exhibit Hall Open

10:00 a.m. - 10:45 a.m.
Refreshment Break and Poster Presentations in Exhibit Hall

10:45 a.m. - 12:15 p.m.
P2: Overcoming the Challenges of a Cost-Controlled Environment
Moderator: Christina Braden-Moore, Marketing Director, Pharmaceutical Systems, North America & EMEA, BD Medical – Pharmaceutical Systems

Due to several market trends related to reducing healthcare cost, as well as a highly competitive market, pharmaceutical companies must find solutions which allow them to thrive in a cost sensitive environment.  Companies must continue to deliver safe therapies which deliver maximum value to patients, while balancing time to market, costs and operational effectiveness.  This session will discuss solutions to manage total cost of ownership and how to manage your overall costs to deliver products to patients.

12:15 p.m. - 1:30 p.m.
Networking Lunch in Exhibit Hall - Sponsored in Part by Mitsubishi Gas

1:30 p.m. - 3:00 p.m.
Concurrent Sessions

A1: Connectivity/Smart Devices
Moderator: Christian Helbig, Head of Strategic Business Field Glass Syringes, SCHOTT Schweiz AG

In recent years, first Connected Health solutions linked to injectable drugs have been successfully launched to the market. While this are great achievement, questions remain on future market trends, regulatory expectation and the overall Ecosystem evolution.

This session aims to reflect on the recent experiences and learnings with respect to the benefits delivered to patients as well as to the companies themselves.

B1: When Packaging Becomes more than Packaging
Moderator: Joel Cotten, Business Development Director, Aptar Pharma

From a high-level perspective Packaging must protect the injectable drugs as well as the intermediate injection systems till they reach the final users, mostly patients and healthcare workers. It appears more and more than the pharmaceuticals packaging are embarking smart innovations that serve other purposes than just the physical protection.  We propose to present in this packaging section some of the most recent innovations in the market that could change the future of the packaging offering.

3:00 p.m. - 3:45 p.m.
Refreshment Break and Poster Presentations in Exhibit Hall                                                  

3:45 p.m. - 5:15 p.m.
Concurrent Sessions

A2: Development
Moderator:  Brigitte Reutter- Haerle, Vice President, Marketing/Corporate Communications, Vetter Pharma International

The development and manufacturing of drugs into delivery devices like syringes requires an intimate understanding of both the drug and the device. This session offers attendees the opportunity to learn how Control Strategy in Design Transfer can help manufacturers better understand what to control in device quality attributes, easing their pathway in transferring the device design into drug manufacturing using drug control strategy tools. Participants will also gain an understanding of GMP requirements for clinical phase 1 and 2 manufacturing of drug products and how to implement them; helping to prepare the product for later stages of development of Critical Process Parameters.

B2: Building Clarity in Addressing Regulatory Challenges for Combination Products
Moderator: Fran DeGrazio, Vice President, Scientific Affairs & Technical Services, West Pharmaceutical Services, Inc.

Prefilled syringes and delivery devices have unique challenges from a regulatory perspective.  It is critical that both drug and device requirements be understood & executed. Additionally, as new innovations get implemented complexity is magnified.  The speakers in this session will provide guidance that one can immediately use in addressing these issues.  

7:00 p.m. - 10:00 p.m.
Networking Reception - Sponsored in Part by Owen Mumford and Sensile Medical

Tuesday, October 9

7:00 a.m. - 5:30 p.m.
Registration Open                                                                                                              

7:00 a.m. - 8:30 a.m.
Continental Breakfast

7:15 a.m. – 8:15 a.m.
Concurrent Breakfast Sessions

Breakfast I:  Innovation to Support Product Stability
Moderator: Brigitte Reutter- Haerle, Vice President, Marketing/Corporate Communications, Vetter Pharma International

Innovations and improvements in development for injectable devices are critical to ensuring drug/device compatibility, safety and performance. Understanding mechanism of action that help to ensure proper deployment and functionality of such systems is vital to performance. This session offers attendees a two expamples that can impact performance and mitigate future risk of compatibility that must be considered when evaluating product quality and stability. 

Breakfast 2
Moderator: Anthony L. Schaff, Sr., P.E., Senior Engineering Advisor, Delivery Device and Connected Systems, Eli Lilly and Company


8:30 a.m. - 10:00 a.m.
P3: Is Your Product Genuinely Patient-Centric?
Moderator:  Nic Bowman, Head of Devices CoE, Pfizer, Inc.

There is increasing evidence linking patient experience with adherence rates and consequent health outcomes. So how can we achieve the best patient experience? Patient capability and preferences are already evaluated throughout the design process using human factors studies. However, patient-centricity requires a deeper understanding of patients’ perspectives, motivations and intrinsic needs.

This session looks at some of the methods used to identify latent user needs, viewing the patient as an individual and enhancing patient experience in ways that they value.

9:45 a.m. - 3:45 p.m.
Exhibit Hall Open

10:00 a.m. - 10:45 a.m.
Refreshment Break and Poster Presentations in Exhibit Hall

10:45 a.m. - 12:15 p.m.
Concurrent Sessions

A3: Impact of Materials and Geometry on Primary Containers
Moderator: Olivia Henderson, PhD, Principal Engineer, Amgen, Inc.

A primary container’s role is to maintain quality of the dosage form by protecting against losses or additions such as a loss of solvent, reaction with oxygen, absorption of water vapor, microbial contamination, or exposure to light. Some primary containers may also have a functional role by serving as a drug delivery device. Traditional materials such as borosilicate glass and butyl rubber generally provide adequate protection, but these materials may not adequately protect all drug products or be the best option for the intended storage temperature or drug delivery. This session explores alternate materials, container designs, and their impact on the drug product and drug product delivery.

B3: Quality Planning and QbD
Moderator:  William Dierick, Fellow, Science & Technology, Terumo Europe N.V.

Quality assurance of parenteral drug delivery devices and primary packaging components is an important element in the total approach to Good Manufacturing Practice (GMP). Designing for quality in using Quality by Design (QbD) concepts enables companies to achieve consistent quality in new products and processes. Using a structured approach for quality planning may provide for tools to mitigate failures and to avoid quality crises. A structured quality-planning framework supports the goals for continuous improvement and customer satisfaction. This session will explore several approaches for achieving sustainable quality for products and processes.

12:15 p.m. - 1:30 p.m.
Networking Lunch in Exhibit Hall

1:30 p.m. - 3:00 p.m.
Concurrent Sessions

A4: Human Factors as a Learning Tool, Not just a Validation
Moderator:Nic Bowman, Head of Devices CoE, Pfizer, Inc.

All drug delivery devices need to pass a summative human factors test before they can be approved and released onto the market. Like a driving test, a summative human factors study doesn’t necessarily represent how you drive, or indeed, intend use a device in the real world.
Human factors investigations need to be completely integrated throughout the device development process, informing the design every step of the way. This continuing evaluation should be happening right through the early investigative and concept stages and on though formative studies and right up to the eventual summative study.

This session will look into different approaches and applications of human factors in both current and innovative ways to gain insight into usability and to guide device development to deliver highly usable devices patients need.

B4: Flexible Filling Lines to Manage Small, Variable Container Products
Moderator: Wenzel Novak, PhD, Market Development Director, Pharma, Optima Machinery Corporation

Blockbuster strategies no longer drive the market of equipment. New approaches ask for a high variability on containers and sometimes very small batch sizes. Based on this, an increased variety of products will be handled on the same equipment. Validation, Qualification and Process set-up will become a more relevant part of the all-over availability of equipment. Historically and presently, we run a trial-and-error approach to prove a safe and reliable process. Better understanding of processes and even the use of artificial intelligence allow a modern way to reduce the risk of replication. Simulating the outcome before even testing helps to minimize cost and time. We will compare the traditional concepts and simulation strategies to improve time to market.

3:00 p.m. - 3:45 p.m.
Refreshment Break and Poster Presentations in Exhibit Hall

3:45 p.m. - 5:15 p.m.
P4: A New Era for Medical Devices and Combination Products.  What is the Impact?
Moderator:  Manfred Maeder, PhD, Head GCA Devices & Combination Products, Novartis Pharmaceuticals AG

This session will discuss the changes of the EU MDR (Medical Device Regulation). This will change the requirements significantly also for DDCs (Drug Device Combinations = Combination Products) regarding additional submission requirements, increased involvement of notified body, and life cycle management of products. We will understand the needs of industry and the positions of the Competent Authority and notified body.

5:15 p.m.
Closing Remarks from Committee Co-Chair
Manfred Maeder, PhD, Head GCA Devices & Combination Products, Novartis Pharmaceuticals AG

Conference and Workshop Registration | October 8-10


By July 30, 2018

After July 30, 2018


By July 30, 2018

After July 30, 2018

Conference Registration | October 8-9


By July 30, 2018

After July 30, 2018


By July 30, 2018

After July 30, 2018

Government/Health Authority


By July 30, 2018

After July 30, 2018


By July 30, 2018

After July 30, 2018



By July 30, 2018

After July 30, 2018


By July 30, 2018

After July 30, 2018



By July 30, 2018

After July 30, 2018


By July 30, 2018

After July 30, 2018

Young Professional Member


By July 30, 2018

After July 30, 2018

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 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 byAugust 9, 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 August 9, 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 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.

Loews Royal Pacific

Loews Royal Pacific
6300 Hollywood Way
Orlando, FL USA 32819
Tel: +1 (407)-503-3000

Rate: Single/Double: $205/per night plus applicable taxes.

Cut Off Date: Thursday, September 6, 2018

(The PDA block of rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate). After the cut-off date, rooms will be available at the prevailing rate based on availability.

Hotel Accommodations

A block of rooms have been reserved for meeting participants at the Loews Royal Pacific. The rate is $205 for single or double occupancy. Please note that over 90% of the Royal Pacific guestrooms are double queen rooms. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Thursday, September 6, 2018. After this date, reservations can be made on a space-and rate-available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

To make reservations, individuals may click on the reservation link above or call the Loews Royal Pacific at +1 (888)-430-4999. Please make sure to tell the reservationist that you are with the PDA group attending the 2018 PDA conference to receive the PDA group rate.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 72 hours prior to check-in to avoid cancellation fees.


Loews Royal Pacific is conveniently located near Universal Orlando™. The venue is a tropical paradise with an unbeatable location right at the epicenter of fun. In addition to enjoying the lagoon-style pool and its own beach. As a guest, PDA attendees get exclusive benefits and access to the theme parks. Each and every one of the 1,000 stylish guest rooms is decorated in an "island chic" style that's as contemporary as it is laidback. The venue also offers a complimentary water taxi to the Universal CityWalk™ area, allowing guest to enjoy a variety of great restaurants and attractions.

Read more about additional information on service and amenities offered at Loews Royal Pacific.


Orlando International Airport- (MCO) is located 18 miles (about 20-25 minutes) northeast from Loews Royal Pacific.

Ground Transportation

Preferred Vendor

Destination MCO has been selected as the preferred vendor for airport transportation for Loews Hotels at Universal Orlando™. Exclusive chauffeured services begin at $115 (tax and gratuity included) for a sedan and can be charged to your geust room. Reservations are required. Visit or call the concierge at +1 (407)-503-5200.

Shared-Ride and Direct Service Airport Shuttles - Special Discount for PDA Attendees

Mears Transportation offers a shared-ride airport shuttle from Orlando International Airport to Loews Sapphire Falls. Tickets are available at the Mears Transportation counters located inside the baggage claim area on level two, as well as on level one where the shuttle departs for Loews Sapphire Falls Resort every 30 – 40 minutes. Reservations are not required. Pricing is shown below.

  • One-way fare: $21 adult or $16 child (ages 3-9)
  • Round-trip fare: $33 adult or $25 child (ages 3-9)

Mears Transportation also offers a direct service airport shuttle from Loews Royal Pacific to Orlando International Airport. Travel time is approximately one hour. Reservations are required. Visit or call the concierge at 407.503.5200 at least 24 hours prior to departure.


Taxis are on standby at Orlando International Airport, offering service to and from Loews Royal Pacific for an approximate fare of $55 each way, depending on traffic conditions. Standard taxis can accommodate up to four people. Travel time is approximately 30 minutes.


From Orlando International Airport
Take the north exit onto the Beachline Expressway (State Road 528) West approximately 11 miles to Interstate 4 (I-4) East. Continue on I-4 East to exit 75A (Universal) and turn left onto Universal Boulevard. Continue on Universal Boulevard to Hollywood Way and turn left. Loews Royal Pacific is on the left at 6300 Hollywood Way.
Note: FL-528 is a toll road with two tolls of $0.75 and $1.00 each between Orlando International Airport and Loews Royal Pacific.

From Florida's Turnpike
Take exit 259 (Orlando) onto I-4 West. Travel on I-4 West to exit 74B (Universal) and continue to Hollywood Way. Turn right onto Hollywood Way. Loews Royal Pacific is the second entrance on the right.

From Eastbound Interstate 4
Take exit 75A and continue to Universal Boulevard. Turn left onto Universal Boulevard and travel approximately one-half mile to Hollywood Way. Turn left onto Hollywood Way. Loews Royal Pacific is the first entrance on the left.

From Westbound Interstate 4
Take exit 74B (Universal) and continue to Hollywood Way. Turn right onto Hollywood Way. Loews Royal Pacific is the second entrance on the right.

From Southbound Interstate 95
Take exit 205 (State Road 528). Travel on FL-528 to I-4 East. Travel on I-4 East to exit 75A and continue to Universal Boulevard. Turn left onto Universal Boulevard and travel approximately one-half mile to Hollywood Way. Turn left onto Hollywood Way. Loews Royal Pacific is the first entrance on the left.

From Northbound Interstate 95
Take exit 260B (I-4 West). Travel on I-4 West to exit 74B (Universal) and continue to Hollywood Way. Turn right onto Hollywood Way. Loews Royal Pacific is the first entrance on the left.

Hotel Parking

Self-parking at the Loews Royal Pacific is $22 overnight or $24 daily. Valet parking is $29 overnight or $34 daily.

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA Universe of Pre-filled Syringes and Injection Devices offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This is a must attend event for all industry professionals involved in the development, manufacturing, marketing or use of pre-filled syringes and injection devices.

At this conference you will be exposed to high quality attendees from a variety of manufacturing companies – making this a must attend meeting. In addition, high profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, Sales

Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296

Register Now