As companies product portfolios have become more complex and supply chains more global, regulators have heightened concerns about patient safety, product quality, and drug shortages. We provide a platform for your team to ask questions with experienced industry experts. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA Regulatory affairs in 2023: key trends and changes Rebecca Parrilla, MS, Compliance Officer/CSO, OMQ, OC, CDER, U.S. FDA, C2: Building Quality into Complex Drug Products There are several options for transportation from Schiphol Airport to the hotel. The 2nd Oligonucleotides CMC & Analytical Development Summit returns this August to Boston, uniting 70+ industry leaders. DIA - Annual Meetings Visit GSK DATA. The course emphasis will include FDA, EMA and ICH guidance. Rebecca E. Dowd, MS, Supervisory Investigator, ORA, U.S. FDA, 08:30 10:00 | P5: Current GMP Compliance Trends and Topics Regulatory Updates | ISPE | International Society for Pharmaceutical Richard M. Johnson, MSc, President and CEO, PDA [emailprotected], Tel: +1 (301) 656-5900 ext. DSI shares upcoming attendance at Events where you can request a meeting, or learn more about Regulatory Compliance and CMC Consulting. Formulation Technologies 7. This Workshop will focus on the currently most relevant topics in the CMC (Chemistry, Manufacturing and Controls) regulatory space with a global perspective. Customize your experience and address your unique concerns during dynamic Q&A after each session. Ernest F. Bizjak,Compliance Officer/Acting Team Leader, OMQ, CDER, U.S. FDA, 16:55 | Data Driven Supplier Knowledge: Management and Governance Vice President, Regulatory Affairs, CMC Biologics - BioSpace Are you struggling with an uptick of quality problems and regulatory scrutiny; challenges that can lead to costly regulatory consequences such as a warning letter or worse yet a consent decree? Combining our expertise in end-to-end operations and our AI-based platform,GenpactCora, we focus on the details all 100,000+ of us. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. 07:40 | Q&A with Additional Panelist Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. Schiphol is 15KM away from the hotel, and Rotterdam 65KM. Regulatory Affairs, Biotech & Pharma - Events - Informa Connect Bethesda, MD 20814 USA International collaboration efforts that improve quality and benefit the consumer are also highlighted. She will verify your status and register you. When the timer goes off, the group will move on to the next hot discussion topics. 5 (direction Amsterdam Central Station) and exit at stop Gerrit van der Veenstraat. Rick L. Friedman, MS, Deputy Director, OMQ, CDER,U.S. We appreciate your participation in WCBP 2023 and hope you consider joining us at WCBP 2024 on January 23-25, 2024. FDA Meetings, Conferences and Workshops | FDA Toni Manzano, Chief Security Officer, Aizon, 16:25 |Agencys View on Data Criticality and Control Mechanisms to Support Data Integrity Program, Including Recent Data Integrity Observations The Renaissance Washington, DC Downtown hotel is located at 999 9th Street NW, Washington, DC. Register Now. The reduction of visible particles in injectable products is an important element in the consistent delivery of high-quality parenteral products. 2022 PDA/FDA Joint Regulatory Conference Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA! Past Events. Dive deep into supporting products as they evolve throughout the products lifecycle and navigate guideline changes and global regulatory harmonization challenges. Meetings and Events - CASSS Home No valid parking. 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. This course will provide insights and practical guidance for the CMC teams to develop an appropriate cost-effective, risk-based CMC regulatory compliance strategy for the manufacture and control of biopharmaceuticals from early clinical stage development through market approval. Kevin J. ODonnell, PhD, Market Compliance Manager, Health Products Regulatory Authority, B2: The Digital Automation Revolution: Implementation and Validation Moderator: Valerie Whelan, Vice President Quality, Thermo Fisher Scientific. The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion 07:00 19:30 | Registration Open Designed to allow engaging dialogue with experts from Regulatory Agencies, International Organisations, and experts from Industry, this Workshop will enable you to partake in interactive cross-functional discussions and hear directly from key stakeholders in this space. Want to revisit a keynote presentation? Make your voice heard and watch our data visualization respond at booth 1835. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Moderator: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, CBER, U.S. FDA. * For this member type or discount, online registration is not available, please contact [emailprotected]. Tel: +49 30 436 55 08-0 or -10 This new instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. Valerie Whelan, Co-Chair, PDA/FDA Joint Regulatory Conference and Vice President, Quality, Thermo Fisher Scientific, 08:30 | Emerging from Covid: An FDA Perspective The PDA/ FDA Joint Regulatory Conference. Real-life examples will address the roles of risk analysis, process performance monitoring, CAPA, digital tools and continual improvement in minimizing human error and its impact. 14:40 | Compliance Premediation Susan Laska, MS, Deputy Chairperson, Pharmaceutical Inspection Co-operation Scheme (PIC/S) and Deputy Assistant Commissioner, OMPTO, ORA, U.S. FDA (INVITED), 07:40 | Q&A with Additional Panelists Workshops, Meetings & Conferences (Biologics) | FDA These emails are sent by scammers. Moderator: Denise M. DiGiulio, Senior Director, Johnson & Johnson. A1: How Effective Is Your GMP Training? The Conference emphasizes the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality. Beat the Monday morning crowd by picking up your badge on Sunday, 11 September from 14:00 19:00! 2022 PDA/FDA Joint Regulatory Conference 12-14 September 2022 Michael J. Abernathy, MS, RAC presenter Amgen, Inc. Michael Abernathy, Executive Director, leads Amgen's Global RA CMC function and is accountable for more than 65 staff globally, and a product portfolio of over 80 programs. Tony Costa, PhD, Chief Executive Officer, DIANT Pharma Inc. 16:25 |Drug Product Development Technical Review and Stage Processes and the PAI Connection 11:10 |Industry Perspective on CMC Data Structuring to Manage Knowledge During Product Lifecycle The interactive format of Please contact us if you are entiteld to receive a discount. Learn through dynamic panel discussions, case studies and real world evidence on current topics directly related to your industry. Regulatory Convergence, Reliance, Collaboration and Work-sharing The impact of the new pharma regulation in CMC Lifecycle Management ICH Q Guidelines: implementation and revision Quality innovation New modalities in CMC: ATMPs, peptides and others Digital Data Dossier: The future of CMC submissions Unmet Medical Needs: PBBM modelling Inspections He has served on the PDA Board of Directors and chaired the PDA Biopharmaceutical Advisory Board. 13:45 | What's New in Pharmaceutical Quality (v.2022) It will also provide recent data from observations related to data integrity/management from recent inspections. Yet truly effective CAPA should normally include mistake-proofing and not solely stop with retraining an operator. 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:. PDA EU00018 CMC Regulatory Compliance for Biopharmaceuticals No other vendor works as hard ensuring you get paid for the work you do. His tweets regularly include crypto jargon like FUD (Fear . Martin G. VanTrieste, President Emeritus & Board Member, Civica Rx, 14:10 | The Halo Effect: A Discussion Interested in becoming an exhibitor? Biologics CMC: Regulatory Challenges and Trends Global Pharmaceutical Regulatory Affairs Summit Virtual Pass Booking Form (Checkout Only) Delivered as a Hybrid Event 23rd - 25th October 2023. , Presented in Central European Time (CET) Straight from regulatory authorities and industry leaders, providing insights into policy and real-world case studies. 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. 07:40 |Q&A with Additional Panelist Our software and service solutions are designed for the unique challenges and requirements of laboratory specialties and the clients they serve. The efficiencies and quality advantages of a 21st century laboratory are substantial, including better method reliability, preventing common manual errors, digital capture of data instead of transcription, more efficient batch release, and built-in data integrity security. IG8: Regulatory Affairs & Supply Chain Management, 07:15 08:15 | Concurrent Breakfast Sessions, Breakfast 1: Digital Twins Dr. Geigert has over 35 years of experience within the biopharmaceutical industry developing and implementing CMC regulatory compliant strategies for biopharmaceuticals. CASSS members have access to all available presentation recordings starting in April 2020. 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. Bring your comments, questions, and ideas to these interactive IG discussions. Moderator: Rosemary Orciari, Director Quality, Pfizer. Our commitment to industry perspectives keeps the program focused on what matters and dynamic session types allow you to stay engaged. The updated monographs will appear in . IGs are your opportunity to make your voice heard! Moderator: Sharyl D. Hartsock, Associate Vice President, Global Quality Systems, Eli Lilly and Company, 14:15 | Contamination Control Strategy: Case Study on Microbiological Application One way taxi fares from IAD is approximately $70 and from BWI about $85. CMC Regulatory Compliance is Challenging for Biopharmaceuticals, 9:10 16:00 | Evolution of Biopharma Processes Rely upon Robust Data Quality: Case Study on Usage of AI in Continued CPV Bethesda, MD 20814 USA Maik W. Jornitz, MSEng,President and CEO, G-CON Manufacturing, 15:05 | Q&A with Additional Panelists If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). roundtable notes. Regulatory Education for Industry (REdI) Annual Conference 2022 Please contact us if you are entiteld to receive a discount. CMC Strategy Forum Europe October 16 to 18, 2023 WCBP 2024 - The 28th Symposium on the Interface of Regulatory and The patient and business benefits of a persistent focus on a preventive (the P in CAPA) mindset throughout operations will be explored. Rapid advancements in science and technology, expanding global markets, and the onset of the pandemic underscored the need for convergence working in sync with continuous improvement and innovation, mitigating supply chain vulnerabilities, and enabling patient access to breakthrough therapies. 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. Priscilla Mara Pastrana Lpez, Consumer Safety Officer, ORA, U.S. FDA Deviations, defects, complaints, and out of specification results are among the areas that require careful investigation to prevent marketed product recalls and supply shortfalls. Regulatory Affairs Professionals Society | RAPS Mahesh R. Ramanadham, PharmD, MBA, Associate Director Scientific Operations, CDER U.S. FDA, C4: Managing External Suppliers: Complexities and Knowledge Management Ravi Patel, Director, Quality Engineering & Metrology, West Pharmaceutical Services, Inc. Breakfast 8: Water Systems The driver will be waiting for you after luggage pick up. 08:00 | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs 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. TELCOR is the proven leader of health care software solutions for revenue cycle management (RCM) software and services designed specifically for laboratories. 1111 Exposition Blvd, Building 100Sacramento, CA 95815 PDA will be making decisions on additional precautionary measures closer to the date of the training course and in accordance with the latest CDC guidance, local requirements, and hotel policies. 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 Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA (INVITED). We dont believe that one approach, one system, or one methodology is absolutely superior. In this session, participants will hear how the use of artificial intelligence (AI) has been applied within the biopharm process validation stages. Regulatory CMC Strategy Meeting 2023 - Proventa International Eur.) Nicole Oliynyk,Executive Director Regulatory Affairs,Ocular Therapeutix, 17:20 | Q&A with Additional Panelists Policy Reporter, acquired byTrialCardin 2019, provides innovative healthcare software solutions to track payer policies in near real-time and enhances market access for the therapies patients need most. IG10: Combination Products & Prefilled Syringes, IG11: Microbiology/Environmental Monitoring, A3: Warning Letters and Consent Decree: How to Avoid Them by Staying in Compliance Frequently the development of the CMC strategy is an afterthought. No credits will be given for cancellation requests received less than 30 days before the event. How often have you found yourself in a fire fighting situation with a project, a lot/batch, a customer audit or inspection where you are doing a significant clean up after the fact with a situation that could have been avoided if there had been a greater willingness to slow down, design, and plan properly before you started? All were willing participants.. Frederic B. Ayers, Advisor - Global Quality Systems,Eli Lilly and Company, 14:40 | Innovative Technologies to Support Contamination Control Strategies Join. All costs incurring in connection with visa affairs shall be borne by registrants. 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. Video, photo, and audio recordings are prohibited at all PDA events. WCBP 2023 - The 27th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products - 24-26 Jan 2023, The Mayflower Hotel, Washington, DC, United States (36544) Visit https://ondemand.casss.org, login to your account, and select from the list of meetings to begin. This flagship conference provides opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. Interested in becoming a sponsor? Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. 07:15 | Panel Discussion Events | PDA | Pharmaceutical Manufacturing Association 13507 - Berlin, Germany 17:45 18:45 | Concurrent Interest Group (IG) Sessions Discussion of the increasing diversity of biopharmaceuticals and the CMC regulatory challenges that they present, Understanding the similarities and differences in CMC regulatory compliance between FDA and EMA for biopharmaceuticals, Biopharmaceuticals are not chemical drugs CMC regulatory compliance consequences of the major differences, Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy, Three (3) interactive components that protect patients CMC, cGMPs and Quality Systems, What the minimum CMC regulatory compliance continuum means for biopharmaceuticals during clinical development, Effective CMC risk-management the five (5) key design elements, Applying the principles of QbD and QRM to biopharmaceutical manufacturing, Applied Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy Cell Bank through Drug Substance, 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, Importance and limitations of small-scale studies for biopharmaceuticals, Adequate and appropriate control of the biopharmaceutical manufacturing process from early clinical development into the marketplace, Extra CMC challenges of antibody-drug conjugates (ADCs), Applied Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy Bulk Drug Substance through Administered Drug Product, CMC strategy applied across the manufacturing process from bulk drug substance to formulation to drug product filling to final drug product to administered drug product, Formulation and container-closure challenges for biopharmaceuticals Impact of components on the biopharmaceutical (e.g., protein aggregation) and impact of the biopharmaceutical solution on the components (e.g., glass delamination), Demonstrating Biologic Comparability After Manufacturing Process Changes, Three (3) key design elements of an effective risk-managed comparability exercise, Comparability contracts with regulatory authorities. Moderator: Sharyl D. Hartsock, Associate Vice President, Global Quality Systems, Eli Lilly and Company. This session will discuss how ICH helps enable modernization and innovation viewed through the lens of the quality discussion group (QDG). Dr. Peter Marks, FDAs Director of the Center for Biologics Evaluation and Research, will kick-off the 31st PDA/FDA Joint Regulatory Conference with a presentation on the synergies between science, compliance, quality, and facility capabilities. Manager, Global Regulatory Affairs (CMC) Amgen, United States; Rita Algorri, PhD is a Manager, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. From the tram stop it is about 5 minutes walking to the hotel. The safety and wellbeing of our attendees is a top priority for PDA; therefore, we will be implementing the following guidelines for training courses: If mandated by national, state, or local guidelines in effect during the dates of any training course, PDA will require masks to be worn indoors regardless of vaccination status. Alonza E. Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA, 12:45 14:15 | Portfolio Steering Committee Meeting (Invite Only). Moderator: Xiuju Lu, PhD, Chemist, CBER, U.S. FDA, 07:15 | International PIC/S Regulatory Perspective on Distant Assessments Cellular Targeting and Intracellular Delivery 3. 16:30 | ICH QDG 2022: Global Harmonization via Improved ICH Implementation Choose your favorite car , register it on your SIXT app and exit the parking garage. AMPLEXOR Life Sciences is a global provider of regulatory, quality and safety software solutions, serving and trusted by pharmaceutical, biotechnology and medical device companies for over 25 years. 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. Guided by our experience reinventing and running thousands of processes for hundreds of clients, many of them Global Fortune 500 companies, we drive real-world transformation at scale. 13:45 | Human Error = Equipment Failure Moderator: Paul Z. Balcer, Program Manager, OC, CDER, U.S. FDA. 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. 84 (TR 84) Integrating Data Integrity Requirements into Manufacturing & Packaging Operations, including the importance of data criticality. Looking for a chance for real discussions and genuine networking? Donald D. Ashley, JD, Director, Office of Compliance, CDER, U.S. FDA, 11:30 | CVM Compliance Updates
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