08:30 10:00 | P3 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. Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards Learn about opportunities and benefits. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Qualification and Training 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. Tom Mayer, MBA, Business Unit Manager, Sonceboz SA Other vaccine platforms and manufacturing technologies that have received less attention will also be important in the future to produce vaccines that can be rapidly manufactured at a low cost, with characteristics needed for easy storage and distribution. Greyhound: The nearest Greyhound station is located at 205 S Lamar St. PDA will not be responsible for any costs incurred by registrants due to cancellation. Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member). Yashvinder Sabharwal, PhD, Chief Executive Officer, CherryCircle Software, Inc. 16:20 | The Digital Gap in the Pharma Industry: Effects in Patients and the Recipe to Succeed in the Journey Celebrate the area while delighting in a meal at Date, our casual restaurant where the locally grown fruit graces the menu. As the development and production of vaccines need to be prepared for the future, participants will also learn how this can be achieved through implementing end-to-end digitization. Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting At this workshop, experts on the revision will answer your most pressing questions and provide solutions for implementation challenges at your organization. The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process. Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. 3 to 4 p.m. Feb. 20. Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company Xi Zhao, Senior Scientist, Merck & Co., Inc. Alex Lyness, PhD, Senior Manager, Research and Technology, West Pharmaceutical Services, Inc. 11:05 | RFID Tracking for Asset Management, Compliance Support, and Process Improvement To make reservations, individuals should click on the reservation link above. This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . Moderator: Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter, 10:45 | Primary Container Sequence for On-body Large Volume Injectors: From Vial to Pre-filled Cartridge This balance would give the pharmaceutical industry the ability to positively impact patients by offering new treatments faster. Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. [emailprotected], Tel: +1 (301) 656-5900 ext. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. Moderator: Maurice Verschuren, MSc, Device Platform Lead Director, Amgen. Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. To make reservations, individuals may click on the reservation link above or call the Renaissance Palm Springs Hotel at +1 (888) 236-2427. 08:00 | Opening Remarks from Conference Co-Chairs and Awards Presentations This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes. The new Annex 1 revision was recently released! 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. May 15-17, 2022. 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. 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 Ontario International airport (ONT) is 70 miles from Hotel. You must have this confirmation letter to be considered enrolled in a PDA event. John Lewin, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS, Chief Medical Officer, On Demand Pharmaceuticals Inc. Learn about opportunities and benefits. The speaker will conclude with a discussion how to apply the lightspeed paradigms for future successes. Tel: +65 64965504 Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are co-hosting the PDA Conference again this year. Nils Berg Madsen, PhD, Director Device Development, Ascendis Pharma The revised Annex 1 contains a significant amount of new and more detailed content on many topics. In January 2020, the first U.S. case of COVID-19 was confirmed, declared a pandemic in March, and by April, nearly half of the world's population was under lockdown. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Parking at the Convention Center costs $10 daily. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1. To progress our organizations to the next level, new and innovative ways of thinking need to be employed. The presenters in this plenary session will speak to the challenges and successes from all vantage points in the partnership. Trending and analysis of gloves and gown environmental monitoring (EM) data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures, and overall training efficacy. Mechanically Priming and Controlling Drug Delivery in a Re-usable Auto Injector Thomas James, Mechanical Engineer, Key Tech 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. Lyophilization IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. 13:00 14:15 | P3: Premises and Barrier Systems Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc. Toni Manzano, PhD, CSO and Co-Founder, Aizon. [emailprotected], Tel: +49 (0) 30 43 655 08-10 Ypsomed is presenting a brand . Weve come together to create effective tools to fight a global pandemic. Ludovic Gil, R&D Engineer, BD, Human Factors Approach to Incorporating Connectivity into Medical Device Connectivity Alastair Willoughby, MEng, Head of Mechanical Engineering, Team Consulting, 16:25 | The Route to Further Sustainability Improvements for Autoinjectors The session will include a discussion on the key opportunities and challenges ahead, as well as how biopharma representatives should evaluate investment options in this future changing market. IG4: Visual Inspection The New Normal in Injectable Drug Delivery. The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. 08:55 | Robert Dean, MBA, Director/Team Leader, Advertising and Promotion, Merck & Co., Inc. 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in Exhibit Hall. This session will introduce some of the more intriguing topics covered and expanded in the revised Annex 1, which were selected based on input from the sterile product manufacturing community, as noted during prior meetings and discussions. A Novel Device for Reconstitution and Administration Finally, we will discuss where commonalities exist between antibody therapies and advanced therapies which would allow the substantial packaging knowledge amassed to date to be translated and leveraged in this rapidly changing landscape. Self Parking Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Tim McLeroy, Executive Director, Marketing & Patient Services, Noble International, C1: New Technologies and Approaches in Manufacturing This Conference will focus on the theme to Level Up: Agility in the New Normal! You must have this confirmation letter to be considered enrolled in a PDA event. After this date, reservations can be made on a space-and-rate available basis only. CUE 2023 will . Recent developments have shown a rising preference for self-administration of drugs, in which autoinjectors have become one of the key delivery devices supporting subcutaneous injections. Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. Statements claiming to offer our attendee lists are fraudulent. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 This opening plenary features keynotes from two senior biopharmaceutical leaders. This session will explain how to get the best internal data from personnel, will reimagine todays regulatory intelligence process from start to finish, and will make the case for disrupting the status quo by driving to a single, globally harmonized Quality Management System. 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies Please contact us if you are entiteld to receive a discount. In the first presentation, Dr. John Ludwig will take the audience through Pfizers amazing journey in developing the COVID-19 vaccine. 11:05 | Industry Working Group Collaboration: Speedbump Navigation during the Implementation of a Bio-Fluorescent Particle Counting System Oct 12, 2022. 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. 15:00 | Environmental and Process Monitoring 15:30 16:30 | P4: Equipment, Technology, and Utilities A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. Palm Springs, CA. Leilei Zhang, Associate Principal Scientist,Merck & Co., Inc. [emailprotected], Tel: +49 (0) 30 43 655 08-10 The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. Fax: +65 6496 5599, PTI - Packaging Tachnologies & Inspection, Manager Registration, Chapters & Membership. Brian Thome, PhD, Head, External Biologics and Gene Therapy Manufacturing Sciences, Biogen. Anne-Sofie Staples, MSc, Industrial PhD Student, University of Copenhagen/Novo Nordisk A/S PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC. 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Gabriele Rustici Venturini, MSc, R&D Engineer - Mechanical Designer, IMA Life, 14:10 | Selecting and Collaborating with Manufacturing Partners to Achieve Successful Product Launch Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. Metals and mining is in our DNA. Mathias Romacker, Executive Advisor,Kymanox, 11:05 | How Innovative Approaches to Subcutaneous Drug Delivery Can Shift the Point of Care from Hospital to Home: Building a Case for Oncology Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices Is there any value in having vendors work together up front to have equipment that more readily integrates with each other? [emailprotected], 4350 East West Highway, Suite 600 October 11, 2022. Steven Lynn, MS, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates Inc. 13:45 15:15 | P4: The Future is Bright! 16:00 | Structured Data Frameworks to Enable Digital Tech Transfer Steven R. Kaufman, MBA, Vice President, Drug Delivery Systems, Stevanato Group, 11:15 | Cross-Industry Collaboration as Enabler for the Rapid and Successful Development of New Injection Devices: A Patch Injector Case Study These emails are sent by scammers. Juan Cheng, Principal Scientist, Merck & Co., Inc. Individuals will be responsible for payment of their own cancellation fees. Agle will also host a print release party with . What if companies could work together to overcome hesitation and adopt new technologies in commercial processes? October 18, 2022 - October 19, 2022. IG1: Biopharmaceutical Manufacturing The group rate at all hotels is $199 for single or double occupancy. Donna Gulbinski, Chief Quality and Regulatory Affairs Officer, Civica. Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK, 07:15 | Advancing PFS Unit Level Traceability with RFID The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. Interested in becoming a sponsor? Process intensification involves practices that improve product yield per unit, where unit could be time, consumables, resources, or footprint. 08:00 | Welcome Remarks from Workshop Co-Chair IG5: Packaging Science 11:05 | Contamination Control: A New Approach to the Reduction of 5-Micron Particles 16:40 | What If Sterile Product Processing Equipment Could Talk? Self-parking in the outdoor Radish Lot is conveniently located on the north end of the hotel at the intersection of Hotel Street and Reunion Boulevard West. Moderator: Josh Gonzalez, Chief Commercial Officer, SHL Medical. B-Lot, 48 hours | $13 Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi, 15:55 | Q&A and Final Discussion with Additioanl Panelists Individuals will be responsible for payment of their own cancellation fees. Jason J. Orloff, ChE, Principal Engineer and Statistician, PharmStat, 11:25 | Continuous Bioprocessing: Regulatory Harmonization and Industry Best Practices Quality and Regulatory Shifts Driving Implementation of Flexible Biopharmaceutical Manufacturing Systems James L. Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc. 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? In and out privileges for hotel guests only. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Sherri Biondi, PhD, Executive Director, Head of Device Development, AstraZeneca, A3: Bridging the Gap: Advancing from Clinical Development Stages to Commercial Market Supply Tel: +65 64965504 [emailprotected], 4350 East West Highway, Suite 600 Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. Radish Lot, 8-24 hours | $19 Dr. Forster will also elaborate on how to leverage insights derived from other industries. Cheryl Stork, Scientist II, Preclinical Translation, Biora Therapeutics. Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc. 11:05 | A 3P Model to Sustainable cGMP Cleaning After this date, reservations can be made on a space-and-rate available basis only. 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 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms Taking place in Palm Springs, CA, the Conference will dive into interactive sessions and multiple tracks that will address innovation and regulatory trends in the universe of application device technology and explore what's next for the future of this field. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA (INVITED). For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P1: Overview of and Revision Process for Annex 1 and P2: Scope, Principles, and Pharmaceutical Quality Systems. Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG. PDA Conference October 18th-19th 2022. For your credit card information safety: Please send your details by fax only, For an easier registration, please note the helpful hints on the registration form. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Set against a backdrop of swaying palm trees and the majestic San Jacinto Mountains, our Coachella Valley hotel captures the essence of desert living. Learn about opportunities and benefits. March 2-3, 2023. Elizabeth Rivera, Technical Services Manager, STERIS Through the understanding of this data, and what it means, our industry can improve its compliance position and continuously improve to produce safe and effective medicine for patients. 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 Leader: Susan M. Dounce, PhD, Director Commercial Technology Development, West Pharmaceutical Services, Inc. 2022 edition of PDA Universe of Pre-Filled Syringes and Injection Devices Conference will be held at Palm Springs Convention Center, Palm Springs starting on 18th October. The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. Technological evolution and introduction of novel technologies are required to meet these patient needs. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs Los Angeles International Airport (LAX) is 124 miles from the Convention Center. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success Regulatory agencies have released new policies, flexibilities in procedures, and updates to guidances on the fly, but what are the lasting impact of these changes on our "new normal?. Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success. Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. The agenda is available! This session will discuss the latest developments in industry standardization. Herve Soukiassian, Assoc. Michael de la Torre, CEO, Redica Systems. Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. Andrea Dwyer, MS, CHFP,Associate Research Director - Human Factors Research & Design,Emergo by UL. Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. Other discounts cannot be applied. Pratik A. Mishra, MEng, Senior Systems Engineer, West Pharmaceutical Services, Inc. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Regulatory Perspective 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 Get in touch with Aenova and contact us here ! DART Light Rail Service: The hotel is conveniently connected to Union Station on the Red and Blue lines and is also a stop for TRE commuter rail to Fort Worth.
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