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| Data Integrity And Compliance | Discover why data integrity is crucial for compliance in the pharmaceutical and biotechnology industries. Data integrity issues, often due to incomplete data, are a leading cause of FDA warning letters, putting your operations at risk of recalls and shutdowns. Learn how to safeguard your lab by ensuring reliable electronic records and proper software validation. Don't miss out—click now to access essential insights that could protect your business! |
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FOCUS ON REGULATORY & COMPLIANCE |
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By Tyler Menichiello, contributing editor | Autologous islet cell transplantation (AIT) is regulated differently than allogeneic islet cell transplantation, which requires a BLA. Imagine Pharma's Dr. Rita Bottino makes the case for changing these regulations to better serve patients with Type 1 diabetes. |
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| New Biologic Drugs: Regulatory Challenges And Concerns | Article | By Parrish Galliher and Brian Hubbard, Cytiva | Along the drug candidate development journey there are many regulatory milestones and hurdles. Here are some tips to assist with up-front planning to alleviate headaches down the road. |
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| Annex 21 – Are We On Track And Is There An Impact? | Article | By Geraldine Carr-Mulry, CAI | What does Annex 21 entail? What makes the process of meeting the requirements so complex and time-consuming? And has Annex 21 inadvertently created additional barriers to supply? |
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| Strategic Considerations For Developing Gene-Based Therapeutics | White Paper | By Aman Khera and Michael F. Murphy, Ph.D., Worldwide Clinical Trials | The forces that impact gene therapy development continue to evolve dramatically. This paper highlights essential aspects for regulatory, operational, and commercial success. |
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| The Cell & Gene Meeting on the Mesa is the sector's foremost annual conference bringing together senior executives in the industry. The program features expert-led panels, exclusive networking opportunities, and 100+ dedicated presentations by the leading companies in the sector. Attracting over 2,000 attendees – over 20% of which are C-level executives – this conference enables key partnerships through more than 5,000 one-to-one meetings. Register today |
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REGULATORY & COMPLIANCE SOLUTIONS |
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| The supply chain for mRNA-based cell and gene therapies presents unique challenges due to the sensitive nature of these products. Join Cell & Gene Live on September 24th for a digital discussion on how the industry can improve the efficiency, reliability, and scalability of the supply chain for mRNA-based therapies. Registration is free thanks to the support of Roche CustomBiotech. |
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