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2018 PDA Universe of Pre-Filled Syringes and Injection Devices

Oct 08 - Oct 09, 2018
Orlando, FL

Transforming Pre-Filled Systems through Innovation

  • Conference
  • The Americas

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Program Highlights

Reap the benefits of attending the 2018 PDA Universe of Pre-Filled Syringes and Injection Devices, PDA's largest conference of the year! Hear directly from the experts about the latest scientific breakthroughs, new technologies, human factors/usability, and global market trends. Plus, visit the Exhibit Hall to explore some of the most innovative services and solutions to support the development and manufacturing of pre-filled syringes and injection devices.

Overview

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

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

Conference Inquiries
Jason E. Brown

Assistant Director, Programs
Tel: +1 (301) 656-5900 ext. 131
Email: [email protected]

Registration Inquiries
Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: [email protected]

Exhibition Inquiries
David Hall

Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Email: [email protected]

Agenda

  • 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 healthcare provider perspectives.

    8:30 a.m. - 9:00 a.m.
    The Triumvirate Designing for Healthcare's 3 Masters
    Kai Worrell, CEO, Worrell Design, Inc.

    9:00 a.m. - 9:30 a.m.
    How Connected Devices and Digital Health Innovations are Bringing Value-Based Care Across the Healthcare Ecosystem
    Paul Geevarghese, Vice President, Market Access, mySugr, A Member of the Roche Group

    9:30 a.m. - 10:00 a.m.
    Questions and Answers/Discussion

    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: Theresa Bankston, PhD, Director, Technical Services, 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.

    10:45 a.m. – 11:15 a.m.
    Effective Collaboration  between Customer and Supplier Leads to Win-Win Results Achieving New Evolving Critical Requirements and Accelerated Speed-to-Market
    Ismael Del Pilar, Senior Manager, External Supply, Amgen Inc.
    Marcelo Abad Landa, Senior Director, WW Manufacturing, Becton Dickinson

    11:15 a.m. – 11:45 a.m.
    How Come Outcomes? The Emerging Importance of Value Based Drug Delivery

    Justin Wright, PhD, Global Head of Innovation, Novartis

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    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: Drug Delivery within the Digital Health Ecosystem: Where Do We Stand?
    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.

    1:30 p.m. – 2:00 p.m.
    Connected Health: Moving Beyond the Hype
    Kevin Deane, Executive Vice President, Front End Innovation, Phillips-Medisize

    2:00 p.m. – 2:30 p.m.
    Wearable Injectors Can Improve Patient Outcomes: A Case Study from Diabetes Management which can be Leveraged for Wearable Injector Platforms for Biologic Drugs
    Anil Busimi, Senior Global Product Manager, SCHOTT AG
    David Henderson, Director of Operations, Beta Bionics, Inc.

    2:30 p.m. – 3:00 p.m.
    Questions and Answers/Discussion

    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 until they reach the final users, mostly patients and healthcare workers. More and more, pharmaceutical companies are using smart packaging with innovations that serve purposes other than just the physical protection. This session will discuss some of the most recent innovations in the market that could change the future of the packaging offering.

    1:30 p.m. – 2:00 p.m.
    Case Study: Implementation of an Innovative High-Speed Laser-Marking Solution on Glass Pre-Filled Syringes
    Teddy Klein, Global Engineering, Technology Program Leader, Sanofi Pasteur
    Patrick Jeukenne, VP Strategy, Pharma Segment, Aptar Pharma

    2:00 p.m. – 2:30 p.m.
    Using Smart Packaging to Enhance Supply Chain Quality of Drug Delivery Devices: How Smart Primary Packaging and Object Aware Machinery Can Lead to Better Quality Outcomes
    Markus Bauss, Managing Director, SHL Connect, SHL Group
    Egmont Semmler, PhD, Director, Research & Development, Groninger & Co. GmbH

    2:30 p.m. – 3:00 p.m.
    Questions and Answers/Discussion

    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.

    3:45 p.m. – 4:15 p.m.
    Integrating Control Strategy in Pharmaceutical and Device Development and Manufacturing for Combination Product Delivery Devices
    Ling Lu, Senior Principal Scientist, Pfizer Inc.

    4:15 p.m. – 4:45 p.m.
    Implementation of Quality Requirements in Manufacturing of Clinical Phase I/II Drug Product
    Natasha Rivas, Director Quality Assurance and Quality Control, Vetter Development Services USA, Inc.

    4:45 p.m. – 5:15 p.m.
    Questions and Answers/Discussion

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

    Pre-filled syringes and delivery devices have unique challenges from a regulatory perspective. It is critical that both drug and device requirements be understood and 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.  

    3:45 p.m. – 4:15 p.m.
    Challenges and Opportunities with Applying Device Software Regulation in a Drug Setting
    Chin-Wei Soo, DRSc Global Regulatory Head, Combination Products and Devices, Genentech, A Member of the Roche Group

    4:15 p.m. – 4:45 p.m.
    What’s  New with the Regulations? A Well-Rounded Approach to Regulatory Performance Testing for Combination Products
    Daniel L. Bantz, Technology Manager, West Pharmaceutical Services, Inc.

    4:45 p.m. – 5:15 p.m.
    Questions and Answers/Discussion

    7:00 p.m. – 10:00 p.m.
    Networking Reception - Sponsored in part by Owen Mumford, Sensile Medical and MedImmune

    Tuesday, October 9

    7:00 a.m. - 5:15 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 two examples that can impact performance and mitigate future risk of compatibility that must be considered when evaluating product quality and stability.

    7:15 a.m. – 7:40 a.m.
    Compatibility Risk of Drug Formulations and Syringe/Autoinjector Functionality
    Galen Shi, PhD, Advisor, Eli Lilly and Company
    Liang Fang, Principal Research Scientist, West Pharmaceutical Services, Inc.

    7:40 a.m. – 8:05 a.m.
    Evaluation of a Silicone-Free Syringe and Stopper Presentation for Use in Biopharmaceutical Drug Product Development
    Caitlyn J. Sofa, Senior Scientist, GlaxoSmithKline

    8:05 a.m. – 8:15 a.m.
    Questions and Answers/ Discussion

    Breakfast II: Case Studies: Leveraging Combination Product Platforms
    Moderator: Anthony L. Schaff, Sr., PE, Senior Engineering Advisor, Delivery Device and Connected Systems, Eli Lilly and Company

    The effort to reduce development costs and to enable faster submission timelines can be facilitated by use of combination product platforms. This session will discuss how the use of platforms can benefit both primary container characterization/qualification and delivery system usability validation.

    7:15 a.m. – 7:40 a.m.
    An Approach to Design and Develop a Platform Primary Packaging System for Parenteral Combination Products
    James K. Mellman, PhD, Device Manager, Novartis 

    7:40 a.m. – 8:05 a.m.
    Simplify Your Usability Validation: Introducing a Novel Approach for Validating Platform Device Usability
    Christoph Jordi, Senior Usability Manager, Ypsomed AG
    Allison Y. Strochlic, MS, CHFP, Research Director, Human Factors Research & Design, UL LLC / UL-Wiklund

    8:05 a.m. – 8:15 a.m.
    Questions and Answers/ Discussion

    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.

    8:30 a.m. – 9:00 a.m.
    When Digital Health Means Behavior Change
    Paul Upham, Senior Principal, Smart Device Technology Center, Roche/Genentech

    9:00 a.m. – 9:30 a.m.
    Investigating the Link between Patient Personality Dimensions and Causes of Non-Adherence
    Claire Everitt, Design Engineering, Lead, Pfizer Inc.

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/ Discussion

    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.

    10:45 a.m. – 11:15 a.m.
    Impulsively-Generated Pressure and Strain Waves in Pre-Filled Syringes During Autoinjector Activation
    Julian Jazayeri, Senior Engineer, Amgen Inc.
    Jean-Christophe Veilleux, PhD Candidate, California Institute of Technology

    11:15 a.m. – 11:45 a.m.
    Flexible Primary Container Closure Systems: Reimagining the Future of Parenteral Drug Delivery
    Akshay R. Kamdar, PhD, Engineering Advisor / Group Leader, Eli Lilly and Company

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    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.

    10:45 a.m. – 11:15 a.m.
    Building a Strong Bridge to Support Device Changes or New Product Presentations
    Sherri Biondi, PhD, Senior Director, Device Development, MedImmune

    11:15 a.m. – 11:45 a.m.
    The Journey to a Pre-Filled On-Body Injector
    Tommaso Borghi, PhD, Design Program Manager, Flex 

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    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.

    1:30 p.m. – 2:00 p.m.
    How to Prevent Medication Errors: An Experimental Study on Self-Injection Device Platform Distinguishability
    Andreas E. Schneider, PhD, Innovation & Business Development Manager, Ypsomed AG

    2:00 p.m. – 2:30 p.m.
    Simulating Stressful, Emergency Use Scenarios During Injection Device Usability Tests
    Allison Y. Strochlic, MS, CHFP, Research Director, Human Factors Research & Design, UL LLC / UL-Wiklund

    2:30 p.m. – 3:00 p.m.
    Questions and Answers/Discussion

    B4: Validation and Qualification Effects on Time to Market of Aseptic Fill-Finish Processes
    Moderator: Wenzel Novak, PhD, Global Senior Director, Business Development, Medical Device Systems, Gerresheimer Buende GmbH

    Blockbuster strategies no longer drive the market of equipment. New approaches ask for a high variability on containers, processes and an increasing variety of products are 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, thinking / calculating ahead of the trials and even the use of artificial intelligence allows 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 theoretical simulation strategies to improve time to market.

    1:30 p.m. – 2:00 p.m.
    Bubble-Free Filling of RTU Pre-Capped Cartridges
    Daniel Kehl, 
    CEO, Swissfillon AG
    Enrico Zanetti, Sales & Business Development Manager, Swissfillon AG

    2:00 p.m. – 2:30 p.m.
    Artificial Intelligence. Machine Learning. Deep Learning. Can These Technologies Be Applied to Pharmaceutical Automatic Inspection Processes?
    Massimo FrassonPhD,
    General Manager, Brevetti CEA Spa

    2:30 p.m. – 3:00 p.m.
    Questions and Answers/Discussion

    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 Devices & Combination Products, Novartis Pharma 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.

    3:45 p.m. - 4:15 p.m.
    The New MDR and Article 117: An Industry Perspective
    Marc Rohrschneider, PhD, Head New Technologies, Novartis Pharma AG

    4:15 p.m. - 4:45 p.m.
    Update on Changes to the EU MDR
    Girish Kumar, PhD, Product Specialist, TUV SUD America

    4:45 p.m. - 5:15 p.m.
    Questions and Answers/ Discussion

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



Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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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.

Loews Royal Pacific

6300 Hollywood Way
Orlando, FL

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Regular Price

Conference and Workshop Registration | October 8-10

Member

By July 30, 2018
$2,645

After July 30, 2018
$3,345

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By July 30, 2018
$2,924

After July 30, 2018
$3,624


Conference Registration | October 8-9

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By July 30, 2018
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After July 30, 2018
$2,595

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$2,274

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$2,874


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By July 30, 2018
$700

After July 30, 2018
$700

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By July 30, 2018
$700

After July 30, 2018
$700


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By July 30, 2018
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After July 30, 2018
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By July 30, 2018
$800

After July 30, 2018
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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.

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Please let us know if you have any special dietary requirement we may assist you with. Please contact us at [email protected] for help.

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All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

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.

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REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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