Participants will vote on their top discussion topic and then a timed, lively discussion will ensue between the participants, IG leaders, and FDA co-facilitators. Cellular Targeting and Intracellular Delivery 3. Susan J. Schniepp, Chair, PDA Board of Directors and Distinguished Fellow, Regulatory Compliance Associates Inc. Our commitment to industry perspectives keeps the program focused on what matters and dynamic session types allow you to stay engaged. Bethesda, MD 20814 USA Nicholas A. Violand, Investigator/Drug National Expert, ORA, U.S. FDA (INVITED), 11:10 | A Case Study: Closed Loop Investigation System Ensures Identification and Remediation of True Root Cause IGs are your opportunity to make your voice heard! Mary E. Farbman, PhD, Associate Vice President, Global Auditing and Compliance Support, Merck & Co., Inc. B3: Innovative Manufacturing: Pathways to Implementation for Biologics and Biotech The challenge for new processes exists as there is limited knowledge available. 08:00 | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs Tel: +65 64965504 Real discussions and genuine networking are often promised, but not always delivered. Each 10 x 10 exhibit booth includes one (1) full conference registration allowing that badge holder into educational sessions and one (1) expo hall only registration for booth staff, allowing access to the exhibit hall only. 11:10 |Industry Perspective on CMC Data Structuring to Manage Knowledge During Product Lifecycle Cambridge Healthtech Institute's conference on Oligonucleotide CMC and Regulatory Strategies brings together top scientists and executives from leading biotech and pharma companies to share insights on new developments in analytical characterization, CMC, manufacturing and regulatory issues. We're pleased to announce that Shankar Vedantam, host of The Hidden Brain podcast, will be presenting "The Halo Effect: A Discussion" during the closing plenary! Explore the benefits of becoming a member. 2023 PDA Pharmaceutical Manufacturing & Quality Conference. Friday, 23 September 2022 Applied Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy - Cell Bank through Drug Substance 9:00 CMC strategy applied across the manufacturing process from cell banks to protein production to purification to drug substance Necessity of confirming cell bank clonality and genetic stability 10:30 Coffee Break [emailprotected], 4350 East West Highway, Suite 600 We push the limits of what's possible using Augmented and Virtual Reality to create revolutionary experiences proven to increase audience engagement and retention rates. October 30 - November 2, 2022 Orlando, FL & Virtually. Tel: +65 64965504 FDA Meetings, Conferences and Workshops | FDA 2022 PDA/FDA Joint Regulatory Conference | Biographies 11:10 | Juan Andres, Chief Technical Operations and Quality Officer, Moderna, Inc. 12:30 13:30 | Concurrent Interest Group (IG) Sessions 20th DIA Japan Annual Meeting 2023. John Geigert, Ph.D., RAC is President of BioPharmaceutical Quality Solutions, in San Diego, California, which for over 15 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical industry (recombinant proteins, monoclonal antibodies), and now for the advanced therapy products (gene and cellular therapy). Connecting People, Science and Regulation, Understand the importance and underlying principles of an effective CMC regulatory strategy for biopharmaceuticals to move their products through clinical development into the marketplace, Learn how to avoid major CMC delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy. Other discounts cannot be applied. JOB FUNCTIONS: (This list is not exhaustive and may be supplemented and changed as necessary.) 13507 - Berlin, Germany The FDA will accept nine applications for the pilot, which is slated to begin on 1 April 2023. Nicole Oliynyk,Executive Director Regulatory Affairs,Ocular Therapeutix, 17:20 | Q&A with Additional Panelists Foster a sense of collaboration and safely connect with peers and expert presenters at this intimately-sized program. Moderator: Jay Jariwala,Senior Director, Regulatory Compliance,Sidley Austin LLP, 16:30 | Your Suppliers' Risk Is Your Risk: Things to Consider While Developing a Robust Supplier Management Program WCBP - CASSS Home Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. The driver will be waiting for you after luggage pick up. Moderator: Patricia F. Hughes, PhD, Senior Scientific Advisor, OPQ, CDER, U.S. FDA, 10:45 |Role of KASA and Other Related Initiatives (PQ/CMC) to Manage Application Assessments and Post-Approval Lifecycle Management Lance M. De Souza, MBA,Director, Compliance Branch, OMPTO, ORA, U.S. FDA Rick L. Friedman, MS, Co-Chair, PDA/FDA Joint Regulatory Conference and Deputy Director, OMQ, CDER, U.S. FDA The scope of this PDA working group's activities will be discussed, including test and inspection methods, acceptance criterion considerations, and training opportunities. Registration will close July 5, 2023. Training courses and webinars - TOPRA Rita serves within Amgen's Advocacy and External Engagement function which fosters collaboration with multiple cross-functional teams to coordinate and progress company and industry initiatives. 13:45 | Haste Makes Waste: Lessons Learned for How to Avoid a Crisis He has served on the PDA Board of Directors and chaired the PDA Biopharmaceutical Advisory Board. David L. Chesney, MSJ,Principal and General Manager,DL Chesney Consulting, LLC Events held in prior. 999 9th Street, NW The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 31st year. Commission adopted the updated general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619) at its 174th session in November 2022. Moderator: Bing Cai, PhD, Division Director, OPQ, CDER, U.S. FDA. Pharmaceutical Research & Development 5. Life Sciences Suite is powered by the Compliance Foundation platform, which enables unified management of data, content and processes in a familiar user interface combined with powerful automation engine that drives complex process automations, migrations and integrations suitable for both cloud and on-premises deployment models. WCBP 2024 - The 28th Symposium on the Interface of Regulatory and Michael J. Abernathy, MS, RAC, Executive Director, Regulatory Affairs, Amgen Inc. 12:30 13:30 | Lunch with the Regulators Across 3 days, senior leaders will leverage knowledge and share thought . This session will discuss how ICH helps enable modernization and innovation viewed through the lens of the quality discussion group (QDG). 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. These monographs now include a section outlining the Ph. CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA. and transparent workshop format. 1. Tracie H. Sharp, MHA,Branch Chief, OC, CDER,U.S. FDA, B1: Speed vs. Quality: Advantages and Pitfalls of Just-In-Time Manufacturing The outcomes of the Forums are: The success of the Forum series further demonstrates the benefits and the need for providing an open forum for dialogue and exchange of scientific and technical advances that are the basis for evolution of regulatory practices. Rebecca Parrilla, MS, Compliance Officer/CSO, OMQ, OC, CDER, U.S. FDA, C2: Building Quality into Complex Drug Products 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. Rebecca E. Dowd, MS, Supervisory Investigator, ORA, U.S. FDA, 08:30 10:00 | P5: Current GMP Compliance Trends and Topics PDA EU00018 CMC Regulatory Compliance for Biopharmaceuticals Tel: +1 (301) 656-5900 If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Register Now. PDA will not be responsible for any costs incurred by registrants due to cancellation. This thought-provoking closing session will discuss how collaboration, innovation, and applying lessons learned to advance industrial quality management are essential to our future success. An exclusive experience with professional thought leaders provides you with direct insight into current solutions. From the tram stop it is about 5 minutes walking to the hotel. Biopharmaceutical manufacturers and academics along with regulatory agency representatives have used the WCBP Symposium to describe and discuss successful approaches in plenary sessions and informal workshop discussions. Alex M. Viehmann, Division Director, OPQ, CDER, U.S. FDA, 07:40 | Q&A with Additional Panelists Canalside hotel with award-winning restaurant, 15 minutes from airport and right next to the Van Gogh Museum. Parking is available onsite at the following rates: Daily Self Parking - $35; Daily Valet Parking - $60.18. Sixt share cares are available at the airport and their entire fleet is hybrid. P 510.428.0740info@casss.org, The William S. Hancock Award for Outstanding Achievements in CMC Regulatory Science, CASSS Award for Outstanding Achievements in Separation Science, Frantisek Svec Fellowship for Innovative Studies, Carter Lauren University of Washington 2023 (6049863 KB), Lindhardt Karsten Biograil 2023 (2663511 KB), CMC Summary Paper: WCBP 2021 Special Edition (1493266 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2019 (199771 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2014 -2 (267653 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2014 (2191329 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2013 - 2 (242450 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2013 (654132 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2012 - 2 (172776 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2012 (352393 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2011 - Part 2 (408649 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2011 - Part 1 (2211848 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2010 - 2 (692383 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2010 (299181 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2009 (2267980 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2008 (1641954 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2007 - 2 (290615 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2007 (203740 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2005 - 2 - Part 2 (297137 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2005 - 2 - Part 1 (193623 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2005 (261657 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2004 (1445323 KB), CMC Summary Paper: CMC Strategy Forum North America Winter 2003 (943835 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2017 (150571 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2016 (2033274 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2015 (352262 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2014 (2822338 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2013 Part 2 (451968 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2013 Part 1 (1678081 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2012 Part 2 (167208 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2012 Part 1 (844161 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2011 (886430 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2010 (922559 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2009 (478673 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2007 (503766 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2006 (268902 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2005 (698431 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2004 - Part 4 (142173 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2004 - Part 3 (199486 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2004 - Part 2 (160216 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2004 - Part 1 (223358 KB), CMC Summary Paper: CMC Strategy Forum North America Summer 2003 (266901 KB), CMC Summary Paper: CMC Strategy Forum North America Fall 2020 (171207 KB), CMC Summary Paper: CMC Strategy Forum North America Fall 2003 (212603 KB), CMC Summary Paper: CMC Strategy Forum North America Fall 2002 (168214 KB), CMC North America 2023 Infographic 800X2000 (227450 KB), CMC North America 2022 Infographic 800X2000 (224248 KB), CMC Strategy Forum North America 2023 Scientific Program (154459 KB), CMC Strategy Forum North America 2022 Scientific Program (26527 KB), To foster collaborative technical and regulatory interactions that advance discussions to consensus concepts; and. Regulatory Education for Industry (REdI) Annual Conference 2022 June 6 - 10, 2022 On This Page Meeting Information Date: June 6 - 10, 2022 Time: 8:30 AM - 4:50 PM ET June 8 Recording:. Make your voice heard and watch our data visualization respond at booth 1835. Click on the tab below to view Speaker Presentations from the most recent meeting, as well as all Summary Papers. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 IGs are your opportunity to make your voice heard! This session will discuss insights into preventing the conditions that result in regulatory actions, and why this is far better than reactive and costly remediation. Led by our purpose -- the relentless pursuit of a world that works better for people -- we drive digital-led innovation and digitally enabled intelligent operations for our clients. Pharmaceutical Regulatory Affairs Conferences 2023 | Pharma and 13507 - Berlin, Germany Valerie Whelan, Co-Chair, PDA/FDA Joint Regulatory Conference and Vice President, Quality, Thermo Fisher Scientific, 08:30 | Emerging from Covid: An FDA Perspective Tel: +1 (301) 656-5900 Mark Wittrig, Director of Quality Operations, Pfizer, C5: Lifecycle Management of Risks: From Original Application Approval to Post-Approval Bethesda, MD 20814 USA Moderator: Denyse D. Baker, PE RAC, Senior Director of Global Regulatory Policy, AstraZeneca, 07:15 | Advancing Regulatory Oversight: An Overview of Initiatives from the Office of Quality Surveillance Moderator: Rosemary Orciari, Director Quality, Pfizer. Phone: +1 (202) 898-9000. Gallery Place Metro Station is 0.5 miles away from the Renaissance Washington, DC Downtown hotel and is approximately $2.50 USD one way to Ronald Reagan Washington National Airport (DCA). This session will address why maintaining compliance with FDA requirements is so important and in the best interests of both manufacturers and patients. roundtable notes. DIA is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow. Appropriate use of data is critical throughout process development; it helps inform a firm's lifecycle problem recognition, control strategy improvements, risk evaluations, and CAPAs. Francis RW Godwin, MBA, Office Director, OC, CDER, U.S. FDA, 08:55 | CBER Compliance Update Fax: +65 6496 5599, Manager Registration, Chapters & Membership. Moderator: CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA. Public meetings involving the Food and Drug Administration: Upcoming events, past meetings, meeting materials, and transcripts Recent meetings are listed on this page. Regulatory CMC Strategy Meeting 2023 | Proventa International | Boston Conferences Overview Speakers Agenda Sponsor Resources Location Fresh CMC Insights Tired of the same conference experience? PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. [emailprotected], Tel: +1 (301) 656-5900 ext. Past Events. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Its holistic Life Sciences Suite solution helps life sciences organizations to be efficient with launching products and breaking into new markets quickly while ensuring quality, efficacy and safety through end-to-end support to product lifecycle processes, data and content management. Take the train from Schiphol to Amsterdam Zuid Station (10 minutes). Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 The validity and efficiency of the analytical methods employed during the continued process validation (CPV) require extensive knowledge of the process. Statements claiming to offer our attendee lists are fraudulent. Rate: Double Room 239 per night*. The hotel can arrange a private driver to pick you (and fellow travellers) up. The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion Ron Branning, MBA, Chief Executive Officer, GXP Quality Systems, LLC. * For this member type or discount, online registration is not available, please contact [emailprotected]. Want to revisit a keynote presentation? Video, photo, and audio recordings are prohibited at all PDA events. Case studies are presented throughout the conference to provide practical insights into these concepts and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. You must have this confirmation letter to be considered enrolled in a PDA event. Moderator: Denise M. DiGiulio, Senior Director, Johnson & Johnson. Oligonucleotide CMC and Regulatory Strategies - OPT Congress September 12 - 14, 2022. Events | Regulatory Compliance | CMC Consulting | DSI If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). 10:45 | Sustainable Compliance Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. 2022 PDA/ FDA Joint Regulatory Conference - 09/12/2022 | FDA
Best School Counseling Programs In New York, Misa Los Angeles Dress On Sale, Articles R