Brian Thome, PhD, Head, External Biologics and Gene Therapy Manufacturing Sciences, Biogen. Reut Atarot, Systems Engineering Manager, West Pharmaceutical Services, Inc. 12:15 13:30 | Networking Lunch and Tech Talks in the Exhibit Hall, A4: Patient-Driven Collaborations and New Delivery Technologies Dallas Streetcar: This is a FREE service provided by DART that picks up at Union Station, connected to the hotel, and runs to the Bishop Arts District, one of Dallas' best areas for food, shops and galleries. 04 hours | $22 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. Technological evolution and introduction of novel technologies are required to meet these patient needs. Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. Arne Rehm, Senior Product Manager RFID/NFC Solutions, Schreiner MediPharm Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery, B3: Human Factors: Your Roadmap to a Successful Submission Palm Springs, CA. Herve Soukiassian, Assoc. Tel: +49 30 436 55 08-0 or -10 Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. 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. 10:45 | Protocol-Based Site Internal Audit Program: A Network-Wide Case Study Agle will also host a print release party with . 13507 - Berlin, Germany Tel: +1 (301) 656-5900 A Novel Device for Reconstitution and Administration 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance For later registrations, PDA Europe will be unable to assist participants in any visa affairs. All costs incurring in connection with visa affairs shall be borne by registrants. What if formulations could be synthesized when and where they are needed? The first speaker will provide experimental results obtained from comparing both glass and polymer silicone-free container closure systems in terms of functional performance and drug stability. In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. The session will begin with a case study that presents one approach to significantly reducing the time to market when building a Vaccine Fill/Finish Greenfield Facility. Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Please call 214 849 6831 for bus information. 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. Reservations must be secured by Friday, 30 September 2022. Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System 115 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 3 people interested. Live, work and be yourself at our inviting, contemporary hotel near the Dallas Convention Center and within walking distance of many tourist attractions, including Dealey Plaza and the Historic West End. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA Conference October 18th-19th 2022. Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG. Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company Leaders: Roundtable discussion to focus on Mobile Manufacturing Task Force. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. These emails are sent by scammers. Mihaela Simianu, PhD, Executive Director, Merck & Co., Inc. D2: Regulatory Intelligence in the Digital Age: Friend or Foe? Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. 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. Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs. Self Parking For example, in viral vector manufacturing, challenges arise due to the constant balance between processing small batch sizes and ensuring the valuable product makes it into the freezer within the time that the product is still stable. Video, photo, and audio recordings are prohibited at all PDA events. Andrea Dwyer, MS, CHFP,Associate Research Director - Human Factors Research & Design,Emergo by UL. Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics [emailprotected], Tel: +49 (0) 30 43 655 08-10 Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. 2022 PDA Annex 1 Workshop: Palm Springs Oct 20 - Oct 21, 2022 Frederic B. Ayers 2022 annex 1 palm springs presenter Eli Lilly and Company Fred was a student-athlete at Franklin College of Indiana and participated in the college's Leadership Program while graduating in 1999 with a Bachelor of Arts (BA) in Biology. Participants that are unable to meet the vaccine requirement or fail to get a PDA-approved accommodation request will not be granted admittance to the event. Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. Please contact us if you are entiteld to receive a discount. The Interest Group will be discussing the recently launched a survey on process validation approaches. Metals and mining is in our DNA. Website| Reservations Link. 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; and. Each speaker will introduce us to implementation success stories and encourage a discussion on its application. Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 If mandated by national, state, or local guidelines in effect during the dates of any meeting, PDA will require masks to be worn indoors regardless of vaccination status. Gabriele Rustici Venturini, MSc, R&D Engineer - Mechanical Designer, IMA Life, 14:10 | Selecting and Collaborating with Manufacturing Partners to Achieve Successful Product Launch 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. Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International, 13:50 | Development of Digital Surround for Connected Devices: Real-Life Case Study 18/10/2022 - 19/10/2022 Palm Springs, CA. 13:00 | Welcome from PDA Leadership and the Program Planning Committee Co-Chairs The ability to rapidly develop and manufacture mRNA vaccines with high efficacy against the SARS-CoV-2 virus is a tremendous public health accomplishment and has spurred widespread interest in mRNA vaccines for multiple infectious diseases and other indications. These approvals typically leave folks in industry at the edge of our seats, but the pandemic has since brightened the spotlight for the whole world. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA. We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Set against a backdrop of swaying palm trees and the majestic San Jacinto Mountains, our Coachella Valley hotel captures the essence of desert living. 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone October 18, 2022 - October 19, 2022. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. For more details visit the concerence website . Palm Springs, CA, 400 East Tahquitz Canyon Way To make reservations, individuals should click on the reservation link above. Subsequently, we will focus on best practices to validate the method using multivariate approach. Chuck W. Seipel, Product Specialist, W.L. All rights reserved. Tel: +1 (301) 656-5900, Am Borsigturm 60 Elizabeth Moroney, Principal Scientist, Bristol Myers Squibb. Join us for our global Metals and Mining conference bringing together . Interested in becoming a sponsor? Video, photo, and audio recordings are prohibited at all PDA events. This session will discuss the impact of the Annex 1 revision on aseptic manufacturing facilities, specifically focusing on equipment design, indirect product contact parts, such as stopper bowls, and critical utilities, such as water systems. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). 08:00 | Day 1 Report Out Individuals will be responsible for payment of their own cancellation fees. 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. Michelle Hatch, MEng,Senior Human Factors Engineer,Genentech, Inc. C3: From IV to SC: Innovative Approaches to On-Body Delivery Systems Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. 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. Radish Lot, 48 hours | $13 Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals The 2023 Palm Springs Symposium on HIV/AIDS " On the Road to HIV Eradication " will be March 23 - 25, 2023 in Palm Springs, CA. Bethesda, MD 20814 USA Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. 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 To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! Nitin Rathore, PhD, Executive Director, Amgen Inc. 16:20 | Advancing Cell Therapy Processing using Evolving Equipment Technologies Anthony C. Bevilacqua, PhD, Principal Scientist, Mettler-Toledo Thornton. 115 Abdelaali (Ali) Sarakha, Inspector, French National Agency for Medicines and Health Products Safety, 10:00 11:15 | P2: Scope, Principles and Pharmaceutical Quality Systems A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? 300 Reunion Boulevard Bethesda, MD 20814 USA 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. Paul Gustafson, PIC/S Chairperson, 08:40 | Insights from a Former Regulator David L. Jones, PhD, Director of Industry Affairs, Rapid Micro Biosystems. All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. Cambridge, MA June 09, 2022-June 11, 2022 HDSA 37th Annual Convention . The conference must talk about all the children in your household, even if the people there are only . Tel: +49 30 436 55 08-0 or -10 At this workshop, experts on the revision will answer your most pressing questions and provide solutions for implementation challenges at your organization. 13:30 | An Overview of International Standards Impacting Delivery Devices, ISO TC84, and Recent Changes to ISO 11608 Series Moderator: Marc Glogovsky, MS, S.M. 08:00 10:00 | P1: Fast Track Vaccine Development and the Benefits of Platforms : New Technology Facilitating Process-Product Communication This workshop will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers challenges and best practices. All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. The revised Annex 1 contains a significant amount of new and more detailed content on many topics. Michael T. Edey, Senior Principal Engineer, Pfizer Inc. 11:05 | Vaccine Development and Production Needs End-To-End Digitization to be Ready for the Next Pandemic 13:00 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal 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. Consider the possibilities: Copyright Parenteral Drug Association. At the completion of this workshop, participants will be able to: PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. D1: Building Back Better: Innovative Options for Audits and Inspections Pratik A. Mishra, MEng, Senior Systems Engineer, West Pharmaceutical Services, Inc. This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. Please be aware that 1 nights deposit will be charged at booking when reserving a room at the Hilton Palm Springs. In this session, the speakers will provide insight into state-of-the-art approaches for advancing contamination control through comprehensive analytics and trending, strategies for reduced particulate recovery, and advanced cleaning techniques using physics. PDA's Universe of Pre-filled Syringes and Injection Devices Conference, 18-19 October 2022, Palm Springs, CA, Aenovas booth number is 605. Lyophilization IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry. Leilei Zhang, Associate Principal Scientist,Merck & Co., Inc. The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will be live in Palm Springs from the 18th-19th October and we're looking forward to seeing you there. A3: Cleanroom Manufacturing: A New Area Across Technology and Processes Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. Other discounts cannot be applied. Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals, 15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces Duncan Paterson, MSc, MBA, Senior Director, Device Development, AstraZeneca 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. Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc. 11:05 | A 3P Model to Sustainable cGMP Cleaning Cancellation requests must be emailed to [emailprotected]. Juergen Metzger, Product Specialist, Sartorius North America Inc.. Design & Customization of Lubricants and Related Materials to Meet the Diverse Needs of the Parenteral Drug Delivery Industry Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. The presenters in this plenary session will speak to the challenges and successes from all vantage points in the partnership. The speaker will conclude with a discussion how to apply the lightspeed paradigms for future successes. Tel: +49 30 436 55 08-0 or -10 You can't miss the closing session "Investing in the Future," featuring Donald Jones, JD, MBA, Chair, Cardiff Ocean Group, and James J. Collins, Jr., MBA, President, Pharmaceutical Delivery Systems LLC. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. With a proven track record of success, our global and diverse team understands the importance of an international, coordinated approach in this highly specialized sector. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 10:40 | Filtration and Pre-Use Post Sterilization Integrity Testing BobChaplinsky, Head of Quality Management Systems, UCB Pharma SA Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. Christopher Andreola, PhD, Sr Product & Innovation Manager - MEDICAL, Nye Lubricants, Inc. (FUCHS Group), Development of a Submucosal Injection Device for an Oral Biotherapeutic Delivery System GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus 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. decide how to keep your child safe. Ulrich Kllisch, PhD, Manager Data Integrity, GxP-CC, 11:05 | A Deep Dive into Industry-Wide Recall Data: Leveraging an Expert Ontology and AI to Uncover Patterns and Insights 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 Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. The aim of this conference is to provide the latest information and to . Chris Hurlstone, MA, Director of Engineering, Team Consulting, 15:00 15:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall, A2: Digital Health Solutions: Focus on the End User Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer.
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