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2022 Pre-Filled Conference

2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference

Oct 18 - Oct 19, 2022
Palm Springs, CA

The New Normal in Injectable Drug Delivery

  • Conference
  • The Americas

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Program Highlights

The agenda is now available!

Overview

The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will continue to build on the reputation of past events while bringing to light the latest advances in the field. This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing together industry experts to share their experiences, new developments, regulatory considerations, challenges, and industry trends in this exciting area.

Continued 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 or other pre-filled containers 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.

Agenda

  • Day 1
  • Day 2
  • Tuesday, 18 October

    08:15 – 10:00 | P1: Opening Plenary
    Moderator: Mathias Romacker, Founder, Romacker Injection Devices Strategy LLC

    08:15 | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
    Susan J. Schniepp, Chair, PDA Board of Director and Distinguished Fellow, Regulatory Compliance Associates Inc.
    Richard M. Johnson, MSc, President and CEO, PDA  
    Mathias Romacker, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Founder, Romacker Injection Devices Strategy LLC
    Jeffrey Givand, PhD, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Executive Director, Device and Combination Product Development, Merck & Co., Inc.

    08:30 | John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer

    09:00 | Industry Representative Invited

    09:30 | Q&A

    10:00 – 10:45 | Refreshment Break and Poster Presentations in Exhibit Hall

    10:45 – 12:15 | P2
    Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc.

    10:45 | Active Engagement between Stakeholders for Complex Intended Use/Therapies: A Collaborative Approach
    Gregg Peterson, MA, CEO, Bexson Biomedical

    11:15 | Cross-Industry Collaboration as Enabler for the Rapid and Successful Development of New Injection Devices: A Patch Injector Case Study
    Reto Jost, Innovation & Business Development Director, Ypsomed AG

    11:45 | Q&A

    12:15 – 13:30 | Networking Lunch in Exhibit Hall

    13:30 – 15:00 | Concurrent Sessions

    A1: Connected Devices and Digital Ecosystems
    Moderator: Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company

    In an effort to continue our journey and understanding of the evolution and challenges of digital health and connected devices, this session will focus on a few key areas – how to design and develop user-centric digital ecosystems capable of incentivizing patient adherence and compliance; how to integrate connectivity into a device and minimize security and other user experience related challenges. Real life case studies will be presented on how to develop commercially successful connected products.

    13:30 | Development of Digital Surround for Connected Devices: Real-Life Case Study
    Graham B. Jones, PhD, DSc, Head of Research and Innovation, Novartis International AG
    Marty Coyne, BEME, MBA, Principal, Matchstick LLC

    13:50 | Integrating Secure and Easy to Handle Connectivity into a Pre-Filled Device for Automated Injection Logging
    Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG

    14:10 | Seven Key Pillars of Successful Connected Injection Device Development
    Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International

    14:30 | Q&A

    B1: Challenges and Opportunities for Moving Treatments At-Home
    Moderator: Josh Gonzalez, Chief Commercial Officer, SHL Medical

    13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations
    Amin Sedighiamiri, PhD, Associate Director, AstraZeneca

    13:50 | Addressing Primary Container Challenges in Autoinjector Drug Delivery: Interim Results of a Multiphase Bioburden Study for a Cartridge-Based Autoinjector
    Amy Hartl, PhD, Director of Process Development, SHL Medical

    14:10 | Moving Patient Training from Clinical to Home Settings
    Tim McLeroy, Executive Director, Marketing & Patient Services, Noble International

    14:30 | Q&A

    C1: New Technologies and Approaches in Manufacturing
    Moderator: Manfred Maeder, Head Device Dev. and Commercialization, Device Dev/Commercialization, Novartis International AG

    In this session, participants will first review primary packaging materials to learn how the needles will behave and if a drug has a propensity for fast drying. This will include an in-depth statistical evaluation. Then, the most important parameters for aseptic filling (sterility assurance) on a fully automated line will be presented, followed by the best set up of a collaboration between partners to successfully launch a product.

    13:30 | Use of Weibull Analysis to Estimate Time of Needle Clogging in Pre-filled Syringes Filled with Fast Drying Propensity Drug Product
    Lynne Liao, Senior Engineer I, Alexion Pharmaceuticals

    13:50 | Advancements in Fully Robotic No-Touch-Transfer Solutions Used to Introduce RTU Containers into Aseptic Isolators, Enhancing Contamination Control and Sterility Assurance
    Gabriele Rustici Venturini, MSc, R&D Engineer - Mechanical Designer, IMA Life

    14:10 | Selecting and Collaborating with Manufacturing Partners to Achieve Successful Product Launch
    Chris Hurlstone, MA, Director of Engineering, Team Consulting

    14:30| Q&A

    15:00 – 15:45 | Refreshment Break and Poster Presentations in Exhibit Hall

    15:45 – 17:15 | Concurrent Sessions

    A2: Digital Health Solutions: Focus on the End User
    Moderator: Theresa E. Bankston, PhD, VP Customer Success, BD

    We continuously endeavor to innovate personalized, user(patient)-centric digital healthcare solutions to drive improved therapy adoption, adherence, and outcomes. This requires an integrated approach, incorporating insights in areas of behavioral science, hardware and software development, data analytics, health economics and outcomes research (HEOR), regulatory and privacy requirements, and more. In this session, presenters will discuss how to navigate the complexities in digital health solution development while maintaining focus on the end user.

    15:45 | Digital Healthcare in Drug Delivery: The Pillars of Hardware and Software to Empower the End User
    Dean B. Minnock, PhD, CEO, Innovation Zed

    16:05 | Evidence-Led Development of Digital Health Solutions Aimed to Improve Patient Engagement
    Andrea M. Pisa, MSc, MA, Head of Human Factors, Crux Product Design Ltd

    16:25 | Rethinking Connectivity: The Data-innovation Loop
    Pari Gaikwad, Head of Digital, Cambridge Design Partnership

    16:45 | Q&A

    B2: Deep Cold Storage: How to Improve Integrity and Stability
    Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK

    As recently faced during the pandemic with the mRNA vaccines but also for other therapies, several drug products will require final container deep cold storage for stability reason. For these applications, CCI and drug product stability remains big challenges. In this session, presenters will describe different approaches to improve and control CCI and drug container interactions during shelf life at low temperatures.

    15:45 | Hybrid Prefilled Syringes Suitable for Cold Storage Vaccines and Biologic Drugs Without Compromising Container Closure Integrity
    Christopher Weikart, PhD, Chief Scientist, SiO2

    16:05 | Pushing the Boundaries for Glass Prefilled Syringes: Container Closure Integrity, Stability and Performance at -80°C
    Ugljesa Babic, Junior Project Manager, Schott Schweiz AG

    16:25 | Evaluation of Pre-filled Syringe Container Closure Integrity at Deep Cold Storage Conditions Using a Combination of Predictive Modeling and Empirical Testing
    Duncan Paterson, MSc, MBA, Senior Director, Device Development, AstraZeneca
    Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc.

    16:45 | Q&A

    C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain
    Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG

    This session will address sustainability as it pertains to drug delivery devices throughout their supply chain. It intends to provide an update on useful tools as well as examples of innovative industry approaches to reduce the environmental impact of drug delivery combination products and devices through optimisation of device design, packaging, and supply chain.

    15:45 | Integrating Sustainability in Device and Packaging Products: Strategies and Opportunities
    Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company
    Naresh K. Budhavaram, PhD, Senior Consultant Engineer, Eli Lilly and Company

    16:05 | Assessing the Environmental Impact of Global Supply Chain Logistics and Supplier Selection for Injection Devices
    Alastair Willoughby, MEng, Head of Mechanical Engineering, Team Consulting

    16:25 | The Route to Further Sustainability Improvements for Autoinjectors
    Emil Fraenkel, MSCEng, Sustainability Engineer, Phillips-Medisize
    Bjarne Sørensen, Director, Front End Innovation, Phillips-Medisize

    16:45 | Q&A

    19:00 – 22:00 | Reception

  • Wednesday, 19 October

    07:15 – 08:15 | Concurrent Breakfast Sessions

    Breakfast 1: Silicone-Free Solutions for Pre-filled Syringes
    Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions

    07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms
    Soeren Miethke, MSc, Senior Scientist PPMD, CSL Behring AG

    07:35 | A Case Study in Fill-and-Finish Machinability of Silicone-free Pre-filled Syringe Components
    Joerg Stumbaum, Project Manager, PPS&P, Vetter
    Chuck W. Seipel, Product Specialist, W.L. Gore & Associates

    07:55 | Q&A

    Breakfast 2
    Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer

    07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions
    Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger
    Rudolf Michael Weiss, Dipl.-Ing., Global Head of Pharma+Medical, Stäubli

    07:35 | A Real-World Example of Sustainable Drug Delivery the Development of the First Reusable Pen Injector for Concentrated Insulin
    Rob Veasey, MSc, Senior Sector Manager, Medical & Scientific, DCA Design International

    07:55 | Q&A

    Breakfast 3: PFS Traceability: Case Studies on RFID-Based Solutions for PFSs
    Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK

    This session will focus on the latest developments in PFS traceability using RFID technology. Speakers will address the challenges, but also new benefits and opportunities for the patient and for the industry.

    07:15 | Advancing PFS Unit Level Traceability with RFID
    Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG
    Herve Soukiassian, Assoc. Director Program Management, BD

    07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes
    Arne Rehm, Senior Product Manager RFID/NFC Solutions, Schreiner MediPharm
    Tom Van Ginneken, Head of Global Product Management for SCHOTT TOPPAC®, SCHOTT AG

    07:55 | Q&A

    08:30 – 10:00 | P3
    Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG

    08:30 | Industry Representative Invited

    09:00 | Sherri Biondi, PhD, Executive Director, Head of Device Development, AstraZeneca

    09:30 | Q&A

    10:00 – 10:45 | Refreshment Break and Poster Presentations in Exhibit Hall

    10:45 – 12:15 | Concurrent Sessions

    A3: Bridging the Gap: Advancing from Clinical Development Stages to Commercial Market Supply
    Moderator: Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger

    Bridging design and process changes from development to commercial market supply can pose challenges in the device development strategy. This session will showcase some industry examples on How to bridge this gap and close out all challenges on the way from lab to production.

    10:45 | Case Study: How to Bridge the Differences Between a Clinical Device Used in Pivotal Clinical Studies and a Commercial Device
    Yik Kit (Grace) Kwok, MBA, Principal Scientist, Merck & Co., Inc.

    11:05 | Optimization of Design Transfer and Commercial Scale-Up: An Autoinjector Case Study
    Amy Hartl, PhD, Director of Process Development, SHL Medical

    11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices
    Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery

    11:45 | Q&A

    B3: Human Factors: Your Roadmap to a Successful Submission
    Moderator: Maggie Reiff,
    Director of Device Development, ApiJect Corp

    This session will cover successful strategies to ensure your combination product and/or medical device receives regulatory approval. Speakers will address the basic requirements of human factors engineering, as well as more advanced topics and strategies for a successful human factor’s submission.

    10:45 | Human Factors (HF) Hot Potatoes: Addressing Key HF Topics in the Design, Development, and Successful Marketing Approval of Drug-Device Combination Products
    Karl J. Saldanha, PhD, Regulatory Program Director, Genentech, Inc.

    11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes
    Esther Foo, PhD, Senior Scientist, Merck & Co., Inc.

    11:25 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices
    Andrea Dwyer, MS, CHFP, Associate Research Director - Human Factors Research & Design, Emergo by UL

    11:45 | Q&A

    C3: From IV to SC: Innovative Approaches to “On-Body Delivery Systems”
    Moderator: Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter

    Drug delivery treatments for disease states requiring higher doses are making the shift from the traditional IV route to subcutaneous (SC) injection. The many advantages of the new ‘on-body’ systems include reduced invasiveness and preparation time as well as improved care and reduced cost. But they also come with challenges. Attend this session and learn about the evolution of these new systems and how they can help transition drug delivery from hospital to home and address market demands.

    10:45 | Primary Container Sequence for On-body Large Volume Injectors: From Vial to Pre-filled Cartridge
    Tom Mayer, MBA, Business Unit Manager, Sonceboz SA
    Mathias Romacker, Founder, Romacker Injection Devices Strategy LLC

    11:05 | How Innovative Approaches to Subcutaneous Drug Delivery Can Shift the Point of Care from Hospital to Home: Building a Case for Oncology
    Andreas Schneider, PhD, Innovation & Business Development Director, Ypsomed AG

    11:25 | Development of a Large Volume Delivery System with a Customized Injection Profile (Case Study)
    Pratik A. Mishra, MEng, Senior Systems Engineer, West Pharmaceutical Services, Inc.

    11:45 | Q&A

    12:15 – 13:30 | Networking Lunch in the Exhibit Hall

    13:30 – 15:00 | Concurrent Sessions

    A4: Patient-Driven Collaborations and New Delivery Technologies
    Moderator: Alessandro Morandotti, Head of the Technical Account Management, Stevanato Group

    Breakthrough developments are focusing on combination products with the end goal of improving patients’ quality of life and increasing therapy adherence. This trend would require adaptations of existing devices and introduction of new injection systems. In this session we will give an overview of new technologies and how key considerations were embedded in the development process to ensure device functionality and patient centricity. Key factors such as Human Factors, patient onboarding, end-to-end manufacturing process, will be presented.

    13:30 | Development of New Reusable Autoinjector for Automated Reconstitution and Injection of Drug from a Disposable Dual Chamber Cartridge
    Nils Berg Madsen, PhD, Director Device Development, Ascendis Pharma
    Paul Erik Fabricius, Director, Front End Innovation, Phillips-Medisize

    13:50 | Integrating Novel Drug Formulation and Wearable Pump Technologies to Deliver Non-Opioid Moderate to Severe Pain Management Outside of the Clinic
    Paolo Golfetto, Drug Delivery Systems Business Development Director, Stevanato Group
    Sheldon Moberg, MA, SVP Drug Delivery, Bexson Biomedical

    14:10 | A Patient-Centered Approach to Development of Novel On-Body Drug-Delivery Solutions for Injectable Biologics: A Study with Multiple Target Groups
    Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer

    14:30 | Q&A

    B4: Regulatory Affairs and Standards: Updates on the New ISO 11608 and EU MDR Article 117
    Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer

    13:30 | An Overview of International Standards Impacting Delivery Devices, ISO TC84, and Recent Changes to ISO 11608 Series
    Robert R. Nesbitt, Director, Portfolio Strategy, AbbVie, Inc.

    13:50 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp)
    Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products (DCP), Genentech, Inc.
    Stephanie Horn, Technical Regulatory Affairs Manager, F. Hoffmann-La Roche

    14:10 | The Entire ISO 11608 Series Standards Are All New - Now What?
    Lee Leichter, RAC, MBA, President, P/L Biomedical

    14:30 | Q&A

    C4: New Technologies and Solutions for Autoinjectors
    Moderator: Maurice Verschuren, MSc, Device Platform Lead Director, Amgen

    13:30 | An Improved Product Development Framework for Designing Reliable Auto Injectors
    David Booth, PE, Senior Consultant, LMI

    13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need?
    Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc.

    14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics
    Christopher Rini, MS, Associate Director, Translational and Clinical Sciences, BD

    14:30 | Q&A

    15:00 – 15:45 | Refreshment Break and Poster Presentations in Exhibit Hall

    15:45 – 17:30 | P4: Investing in the Future
    Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc.

    15:45 | Donald Jones, Chair, Cardiff Ocean Group

    16:15 | Industry Representative Invited

    16:45 | Q&A

    17:15 | Closing Remarks from Committee Co-Chairs

Highlighted Speakers

Sherri Biondi
Sherri Biondi
AstraZeneca
Amy Hartl
Amy Hartl
SHL Medical
Akshay R.  Kamdar
Akshay R. Kamdar
Eli Lilly and Company
Christian Kollecker
Christian Kollecker
Harro Hoefliger
Lee H. Leichter
Lee H. Leichter
P/L Biomedical
John Ludwig
John Ludwig
Pfizer, Inc.
Mathias Romacker
Mathias Romacker
Consultant

Additional Information

  • Learning Objectives

    Learning Objectives

    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
    Departments
    • 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

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Travel

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.

Palm Springs Convention Center

277 N. Avenida Caballeros
Palm Springs, CA

Palm Springs Convention Center
Renaissance Palm Springs Hotel

888 Tahquitz Canyon Way
Palm Springs, CA
Phone: +1 (760) 322-6000
Website | Reservations Link

Hilton Palm Springs Hotel

400 East Tahquitz Canyon Way
Palm Springs, CA
Phone: +1 (760) 320-6868
Website | Reservations Link

  • Accommodations

    The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA.

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel. The group rate at both hotels is $199 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, 23 September 2022. After this date, reservations can be made on a space-and-rate available basis only.

    To make reservations, individuals may click on the reservation link above or call the Renaissance Palm Springs Hotel at +1 (888) 236-2427 or the Hilton Palm Springs at +1 (800) 445-8667. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    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 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

How to Get Here

By Air

Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. This airport is serviced by numerous carriers. Taxi fares from PSP are approximately $10 one way, not including tip, and will take about 7 minutes.

By Car

The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot). Parking at the Convention Center costs $10 daily.

Other Options

Ontario International airport (ONT) is 70 miles from the Convention Center. Los Angeles International Airport (LAX) is 124 miles from the Convention Center.

Directions

Registration Fees

Regular Price
Registration Type Early Registration After 21 August
Member $1,995 $2,495
Non-Member $2,295 $2,795
Govern./Health Authority/Academic (Member/Non-Member) $700 $700
Student (Member/Non-Member) $350 $350
Early Career Professional (Member Only) $1,245 $1,245

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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