Events

Select event terms to filter by

« Thursday September 02, 2010 »
Thu
Vendor selection in clinical trials, assessment activities, audits and log of preferred partners Start: 09/02/2010 10:00 am End: 09/02/2010 11:00 am In this Clinical Trial training learn about clinical trial Vendor Assessment, Project Management, Outsourcing, and Trial Design. Why Should You Attend: When it comes to clinical trials, trial Sponsors have now the opportunity to outsource anything from the design phase to medical writing and even submission of marketing applications for the product. It is an undeniable challenge for any sponsor to perform this outsourcing in a cost effective manner, while ensuring that this has been conducted reliably and under compliant circumstances. Pharmaceutical companies are reducing the internal resources, while conducting more clinical trials than ever before. At the same time, the growing complexity of the design of the trials is becoming critical to the integrity of the trial data as well as the costs relating to its conduct. How would you assure that the right vendor is in charge of your trial? How can you protect your business interests while ensuring the quickest and least costly way to bring your product to the market? As the sponsor what is your responsibility, even if you have outsourced “everything” to your vendor? Attend this webinar to understand the best practices of vendor pre-assessment, selection and post-assessment including performance assessment and how to manager vendors. Areas Covered in the Seminar: Background of Outsourcing. The Current Industry Trends. Advantages vs. Weaknesses of Outsourcing. Regulatory Expectations. Suggested Process For Vendor Pre-assessment & Selection (Incl. Documentation). Managing Vendors. Performance Assessment for Future Trials (Lessons Learned). Identifying & Logging Preferred Vendors. Navigating Pediatric Trials from recruitment to successful on-time completion Start: 09/02/2010 10:00 am End: 09/02/2010 11:00 am In this Pediatric Trials training learn how to evaluate the current issues and best practices in pediatric drug development, clinical investigation of medicinal products and non clinical evaluation of pediatric drug products. Why Should You Attend: Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol. When conducting research on children, drug companies must ensure that ethical boundaries are observed in both the design and execution of pediatric trials. Attend this Webinar to understand the ethical, economic, regulatory and technical considerations when conducting clinical studies on children. Discussions evaluate the current issues in pediatric drug development and discuss approaches and best practices for overcoming these challenges. Areas Covered in the Seminar : Compilation of various regulatory and guidance documents from the FDA and OHRP on the conduct of research involving children. Recent guidances on compliance and general considerations in the conduct of research on children. General Considerations for the Clinical Evaluation of Drugs in Infants and Children. Discuss Clinical Investigation of Medicinal Products in the Pediatric Population. Nonclinical Evaluation of Pediatric Drug Products. Optimizing Overall Manufacturing System Performance: Cell Culture Supplementation Time: 16:00 GMT Opportunities to optimize manufacturing system performance can be found through cell culture supplementation. Specifically in animal-free cell culture supplements. InVitria, a company specializing in cell culture media supplements, is leading the way in animal-free supplements. InVitria conducted several experiments with Matt Croughan at Keck Graduate Institute. Here are the findings: - The benefits of animal-free supplements have been proven in small scale for research & development as well as mass production with bioreactors - The use of cell culture supplements in increasing overall performance in manufacturing systems has shown to be beneficial for both performance and consistency Key learnings: • Cell Culture Strategies in Optimization of Overall Manufacturing Performance • Effects of Cell Culture Supplements Relative to Productivity • Animal-Free Supplement Benefits The speaker: Steve Pettit - Director, Cell Culture Development, InVitria. Steve has over 20 years of cell culture and virology experience. Additional Speaker: Brittany Medbery - Marketing Coordinator, InVitria This is a must attend webinar for Managers, Supervisors, and R&D in the biopharmaceutical formulation and manufacturing, bioprocessing, stem cell and regenerative medicine, medical devices and diagnostics, and those involved in life sciences research. Technical Requirements - PC headset - PC speakers - Broadband Connection