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). International Council for Harmonisation. 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. Pharmacol. on relevant CMC issues throughout the lifecycle of a product. 1 May 2012. Missed important details that may impact your work? 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. The Regulatory CMC (Chemistry, Manufacturing and Controls) and Product Quality Track provides a comprehensive overview of risk-based approaches throughout the product lifecycle. The CMC regulatory strategy should ideally be linked and integrated with the wider regulatory strategy to ensure an appropriately formulated product is available that meets the requirements of the . CMC regulatory strategy planning Identify planned and potential registration areas Applicable laws and regulations Review and approval timelines and procedures Product type (evaluate by region) Small molecule or biologic New chemical entity (NCE) Dosage form and route of administration Generic (abbreviated new drug application, ANDA, 505 (j)) Cell and Gene Therapy Products: Manufacturing, Quality and Regulatory Considerations June 27 to 29, 2023 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. Published online 14 January 2013. Consults with the physician regarding the Senior metrics for the appropriate length of stay for the Skilled population. 3: Validation of Dry Heat Processes, PDA 102.3 Technical Report No. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 2023 PDA Pharmaceutical Manufacturing & Quality Conference. 5635 Fishers Lane, Suite 400 Karlton P, Johnston D. An integrated approach to the preparation of global CMC dossiers. The hotel can arrange a private driver to pick you (and fellow travellers) up. Since TrainingPros was founded in 1997, we have been dedicated to helping our clients find the right consultant for their projects. At every stage, we navigate our clients to realize efficiencies in cost and time with our integrated and comprehensive solutions. Published online 11 November 2011. Building robustness also needs senior management to be in agreement about any process change strategy and enabling implementation teams at the ground level to have the authority to drive remediation programs to completion. March 15 - 16, 2022 EDT. E-mail address & Password Combo is invalid, Twin Cities Chapter Hybrid Event: The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions, Introduction to eCTD: Structuring your first CTD based submission (March 2023), Sponsored Webcast: Leveraging Technology to Drive Strategic Impact, The Evolving Regulatory Landscape in Oncological Drug Development, San Francisco Bay Area Chapter: Things to Know About IEC 60601-1 Amendment 2, Preparing for an FDA PAI or BIMO Inspection, Wisconsin In-person Chapter Event: Challenges and Lessons Learned from both an Industry and Notified Body Perspective for the Implementation of EU Regulations, US Regulatory Essentials, Devices (April 2023), San Francisco Chapter Event: Clinical Trial Data Privacy and Protection- Fundamentals, China NMPA Regulations on IVD and Companion Diagnostics (April 2023), San Francisco Bay Area Chapter Hybrid Event: Top 3 Mistakes to Avoid in your 510(k) Submission to the FDA or Third Party. Follow the signs car rental from arrivals and walk your way through the end and take the elevator to -2 .You will find the SIXT parking at row 99. Bethesda, MD 20814 USA They are: Copyright 2019-20 Magnus Group. The Regulatory CMC Project Manager is responsible for the planning, managing, and tracking of the regulatory portfolio of submissions for the Vertex Cell and Gene CMC function. The companys patented software-driven solutions include a suite of billing and reimbursement tools for providers and laboratories, market intelligence tools for payers, and a suite of market access solutions for life science companies. May 31 June 1, 2023 | Arlington, VA, Target Audience: Labeling, Regulatory Affairs, Regulatory Labeling, Technical Writing The regulatory structure around which smart CMC development must occur (in the current highest-value markets) principally comes from the United States Food and Drug Administration (FDA), the European Medicines Authority (EMA), and the International Conference on Harmonization (ICH). 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. Dated 15 June 2016. International Council for Harmonisation. The salary range for this position is: $77,000.00 - $148,000.00 USD. Target Audience: Regulatory CMC, Regulatory Affairs. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. Regulatory affairs have a very specific impact within the healthcare industry. Case Studies. Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk M7(R1). The key to building your knowledge and seeing things from another perspective. TELCOR RCM, our SaaS solution, and TELCOR Revenue Cycle Services, our billing service, are designed to streamline workflow, improve collections, and provide real-time analytics. 2014. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. It is also important to identify clearly the decision-makers, and agree on and define the roles and responsibilities from the beginning, as a compliance program will likely require difficult decisions to be made. 1.5 RAC Credits LEARN MORE Regulatory Conferences 2023/2024/2025 lists relevant events for national/international researchers, scientists, scholars, professionals, engineers, exhibitors, sponsors, academic, scientific and university practitioners to attend and present their research activities. Since such requirements and expectations change with time, a function of CMC regulatory compliance is to ensure that all CMC practices are updated accordingly. The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion Contributes to medical and nursing staff education by giving periodic in-service presentations. Dr. Geigert has over 35 years of experience within the biopharmaceutical industry developing and implementing CMC regulatory compliant strategies for biopharmaceuticals. Frequently the development of the CMC strategy is an afterthought. received strong support from ANVISA-National Health Surveillance Agency, as well as GrupoFarma Brasil, Interfarma-Association of Pharmaceutical Research and several other Latin America regulatory agencies, to launch theCMC Strategy Forum Latin Americain 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. Interested in becoming an exhibitor? Fax: +65 6496 5599, Manager Registration, Chapters & Membership. June 7-8, 2023 | Virtual Event, Target Audience: Advertising & Promotion, Regulatory Affairs, Marketing, Legal Counsel Regulatory affairs are also known as government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals like plant protection products and fertilizers, energy, banking, telecom, etc. No valid parking. Stephen Antonelli, PhD Michael Craig, BSc Pharm, MPSI, RF Quarterly|30 September 2022|Citation October 24-25, 2023 | Chicago, IL, Target Audience: Sourcing, Procurement, Supply Chain, Target Audience: Regulatory Affairs, Regulatory Compliance, Regulatory Intelligence, MDR Project Lead, Target Audience: Quality Operations, Quality Assurance, Manufacturing Operations, Target Audience: Packaging, Materials Management, Package Engineering, Target Audience: Sterilization, Microbiology, Sterilization Science, Sterility Assurance CASSS has also organized the CMC Strategy Forum Japansince 2012 with strong support from the Pharmaceuticals and Medical Devices Agency (PMDA). 2023 PDA/FDA Joint Regulatory Conference. One possible option to avoid this aspect, and ensure a level of impartiality, is to use a suitably experienced regulatory outsourcing provider for critical parts of the project. on March 10 as we celebrate #LatinaHistoryDay at their 32nd Annual Conference . 13507 - Berlin, Germany GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. The Forum had its beginning in the US in 2002 with roughly three Forums being held each year, two in conjunction with the Well Characterized Biotechnology Products (WCBP) conference series in January and Their projects DNA reactive ( mutagenic ) impurities in pharmaceuticals to limit potential carcinogenic M7. And implementing CMC regulatory compliant strategies for biopharmaceuticals experience within the biopharmaceutical industry developing and implementing CMC regulatory compliant for!, we navigate our clients find the right consultant for their projects 20814. 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