Submission publishing for investigational drug programs can be prohibitive and costly as health agencies require ever more submission types in electronic formats like eCTD (electronic common technical document). Rapidly changing regulatory requirements and mandates across markets makes maintaining compliance increasingly difficult. The volume of the documentation can vary significantly and be quite an undertaking for pharmaceutical companies. These challenges demand cutting edge models that offer careful planning, efficiency, cost savings, workforce flexibility and execution of high-end submissions. Having the right partner and level of collaboration is key.
During this webinar, we show you how Certara regulatory operations specialists were able to partner and collaborate with Advaxis, Inc., a clinical-stage biotech company, devoted to the discovery, development, and commercialization of immunotherapies, to optimize their regulatory operations processes and ensure their timely submissions, mitigating their risk of errors and costly delays. Using this case study, we share how we were able to turn their challenges into opportunities, achieving major wins.
Learn how we partnered together to achieve all project milestones and regulatory submission success.
Upon the conclusion of this webinar, you will be able to:
- Understand the complexity, risk, time and cost factors involved in regulatory submissions
- Learn why selecting the right partner and level of collaboration to navigate unexpected regulatory challenges is key to ensure your submission stays on track
- Experience first-hand how Certara’s team of regulatory experts defeated regulatory operations challenges, achieving major wins for our biotech client
Speakers
Dr. Suzanne Minton
Director of Content Strategy, Certara
Dr. Minton has 9 years of corporate marketing experience with expertise in scientific content strategy and communication. Dr. Minton also spent 5 years conducting biomedical research on HIV and cancer. She holds a BS in biology from Duke University and a PhD in pharmacology from the School of Medicine at the University of North Carolina, Chapel Hill.
Jerome Perez
Regulatory Operations Specialist, Certara
Mr. Perez is a skilled editor, with experience in handling different types of documents like journals, books, and financial documents from well-known publishers. He ensures document integrity by checking completeness of task information, prioritize tasks, and ensure quality/timely delivery of project. He is also knowledgeable on troubleshooting (working on corrupted files and software malfunction), communicates with clients on issues, and ensures day-to-day update of monthly team production.