Location: BioM Biotech Cluster Development GmbH, Am Klopferspitz 19a IZB-West D-82152 Martinsried
Navigating Regulatory Landscapes:
Understand the global regulatory landscape in Europe and the US, including the benefits of engaging with regulatory agencies during drug development. Learn how to prepare for agency meetings and ensure compliance with quality assurance standards throughout the development process.
Market Access Strategies:
Gain insights into planning successful market access strategies, particularly focusing on the German and European markets. Explore the impact of the new EU Health Technology Assessment (HTA) regulations, managing the German Pharmaceutical Market Restructuring Act (AMNOG) process, and navigating price negotiations and international referencing.
Logistics in Drug Development:
Delve into the often-overlooked aspect of logistics in drug development, covering supply chain management from early development to commercialization. Explore which materials require logistics support at each stage of development, factors influencing feasibility and costs, and real case studies from industry experts.
Interactive Q&A Session:
Bring your questions and current challenges for an engaging Q&A session. Exchange ideas and best practices with fellow professionals in the field.
Why attend:
- Gain valuable insights into navigating regulatory complexities and market access challenges.
- Learn strategies to optimize logistics management throughout the drug development process.
- Network with industry experts and peers to exchange ideas and best practices.
- Acquire practical knowledge through real case studies and interactive sessions
Who should attend:
Professionals involved in:
- Regulatory Affairs
- Market Access
- Clinical Development
- Supply Chain and Logistics
- Quality Assurance
- Research and Development
If you can´t join the event in person you can always register for online attendance here
