Modified release tablets: from Early Stage Development to Life Cycle Management
Sponsored by: Skyepharma
- Modified Release Tablets
Date: 2 December
Days to go: 37
Time: 3PM London/10AM New York
Examples of challenges successfully met
Recent research in the pharmaceutical industry focuses on improving patient compliance and drug administration for already established products or molecules recognised for their therapeutic value. Following this trend, , Pharmaceutical companies work on achieving better product development whilst reducing development costs, keeping generating value and accelerating time-to-market.
In this webinar, Dr. Mathieu Degomme, Project Leader in Pharmaceutical Development and Dr. Elisabeta Comsa, Regulatory Affairs Manager, will present how to address a specific target product profile for versatile applications. They will describe concrete case studies of early-stage development programs for complex tablets and explain their approach to achieving time-to-market goals and navigating the regulatory environment.
Then, from their expertise in modified release tablets, they'll give an overview of their support in lifecycle management and regulatory aspects for generic development phase, technology transfer, troubleshooting and dual source API implementation,
Register now for this webinar to see on how to add value to your product portfolio without impacting your time to market.
Pharmaceutical Development Project Manager
Mathieu Degomme graduated from the University of Limoges (France) in 2009 and, the same year, received his MSc in Development and Production of Pharmaceutical Products from the University of Lyon (France). He then achieved his PharmD, also in 2009, as an apprentice in the validation department at Boiron (France). Again, in 2009, Dr Degomme joined Advanced Accelerator Applications and worked in the production, control and release of radiopharmaceutical sterile products. He joined Skyepharma in 2013 as Quality Assurance Manager and Qualified Person, and was appointed Project Manager at the New Product Introduction Department in 2017.
Regulatory affairs manager
Elisabeta Comsa is a pharmacist and holds a PhD in Pharmaceutical Sciences. With a strong background in regulatory affairs, market access and R&D, she currently manages regulatory activities at Skyepharma. Strongly motivated to ensure fast market access and a performant valorisation of pharmaceutical products, Skyepharma is building an agile regulatory team that can support, in a personalised manner, all pre-approval, registration and drug life-cycle management activities.
Key Learning Objectives
- Explore the potential to create new products using complex tablet technologies
- Examine the advantages of using complex tablets to improve drug administration
- Understand how life cycle management can add value to your product
- Director/Manager of Pharmaceutical Development
- Director/Manager of Formulation Development
- Formulation Scientist
- Manufacturing Scientist
- Director/Manager of Manufacturing
- Director/Manager of Clinical Manufacturing
- Director/Manager of R&D
- Heads of Outsourcing
- Chief Scientific Officer
- Heads of Research and development
- Pharmaceutical project managers
- Founder and CEO
- Procurement - Manager/Director/Head/VP