PDA - Parenteral Drug Association

Check out this expert interview with Lee Leichter, RAC, MBA, as he gives a behind the scenes look at the PDA Combination Products Workshop!

Join us for the PDA 100 Aseptic Processing training course! This 2-week, in-depth training course will provide a comprehensive background of knowledge for professionals involved in sterile product manufacturing. This training course will help participants improve their aseptic processes and address contamination control issues that they may encounter. During this course you will learn about: • environmental monitoring systems • facility cleaning and disinfectant qualification • aseptic cleanroom operations • filtration • sterilization • aseptic process simulation (media fill) • regulatory requirements Don't miss out on this immersive, hands-on experience! For more information and registration: https://bit.ly/3yHKqUi

Exciting Speaker Panel Ahead! We look forward to kick off this year's PDA BioManufacturing Conference on 24-25 September in Gothenburg, Sweden with a powerful keynote from a patient perspective, setting the tone for meaningful discussions on patient needs. Don't miss the chance to connect with industry, academic, and regulatory leaders like Paul Matejtschuk (MHRA), Mats Welin (Medical Products Agency Sweden), Robin Levis (U.S. FDA), Steffen Gross (Paul-Ehrlich Institut), Emmanuelle Charton (EDQM) and others. Key sessions will explore biopharma innovations, advanced modeling, and new regulatory strategies for sustainability. Looking forward to a week of impactful insights and collaboration! Make sure to not miss out and get registered today: https://bit.ly/3xFksjd

Exploring test methods for pre-filled syringe systems on 18-19 November in Italy! What to expect? 📌 Delve into the intricacies of pre-filled syringe systems at the Stevanato Group plant in Piombino Dese. 📌 Gain comprehensive insights and practical insights in a laboratory setting, including ISO compliance testing, during this forthcoming interactive seminar. 📌 Join us for an informative session led by seasoned instructor Horst Koller from HK Packaging Consulting GmbH, as he imparts invaluable firsthand knowledge and guides you through the entire lifecycle of a pre-filled syringe, from conception to market. Interested in learning more about the training? Take a look at the agenda for more details on the program. Spaces are limited! https://bit.ly/3ydVtnk

Free Technical Report Live! Behind the Scenes of Technical Report No. 46 📅 06 September 🕘 9:00-10:00 EDT Join us for this webinar to hear directly from the authors and industry subject matter experts about the thoughts and reasoning behind Technical Report No. 46 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users. Speakers: -Rafik H. Bishara, PhD (Co-Lead) -Erik J. van Asselt, PhD (Co-Lead) -D. Mark Maurice Technical Report No. 46 provides recommendations and tools based on current best practices to ensure that product quality is maintained in the last mile, including guidance on temperature control, monitoring and security, and data management, with a focus on supply chain management. Additionally, it covers supply chains in Europe, Africa, Brazil, U.S., Canada and China. TRLs are complimentary (open to members and the public) and are available live and on demand.

Our President and CEO Glenn Wright shared insights into common challenges in Biologics License Applications (BLA) at the Continual Improvement of CDER BLA Submission Assessment and Facility Readiness/Inspection: CMC for Biologics & Biosimilars public meeting. This meeting, organized by the Duke-Margolis Institute for Health Policy and supported by the FDA, took place today at the National Press Club in Washington, DC. Thank you to the meeting organizers for the invite!

Attend the PDA/FDA Joint Regulatory Conference 2024 to hear directly from Peter Marks, MD, PhD! Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016. He is a member of several professional societies and was elected to the National Academy of Medicine in 2022. For more info about the speakers and agenda, visit https://bit.ly/4eOt1cA

Join us for our Technical Report Live on Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages! 📅 Friday, 23 August 🕐 9:30-10:30 EDT 📍 Online Technical Report Live (TRL) is an informal event, similar to a fireside chat, where attendees will hear insights into the thoughts and reasoning behind the technical report. We're looking forward to having you at our event! Register for the TRL: https://bit.ly/3SyCawr Download your FREE copy of TR 68: https://bit.ly/4bKiDQR

🚨 Last chance to secure your exhibition spot at the PDA Annex 1 Workshop 2024! We're nearly sold out, with fewer than a handful of tabletops left! Don't miss the opportunity to elevate your presence and connect with a diverse audience, and choose from tailored sponsorship packages that meet your marketing goals and budget. Workshop Highlights: -Address challenges of the revised EU GMP Annex 1 -Gain insights into updated requirements -Hear from industry experts and regulators -Participate in interactive sessions and best practice sharing Join us in Dublin for two days of learning, collaboration, and valuable industry insights. Act now before it’s too late! ⏳

Check out this expert interview with Laurent Jeanmart and Brigitte Reutter-Haerle, as they give an inside look at the largest event for prefilled syringes and injection devices!