Join us on December 4th for the next edition of our Halloran Speaker Series, which will kick off a 4-part series titled Roadmap for Success: Streamline and Expedite your Development Program.
Kathrin Schalper, Ph.D., Strategic Development Advisor at Halloran Consulting Group, will share insights and highlight some of her strategies for streamlining and expediting drug development programs. Her talk will feature an overview of the benefits of engaging the right health authority at the right time on the right subject while leveraging different geographies. Additionally, Kathrin will provide an in-depth review of special designations and accelerated approval pathways as an important tool in efficiently developing innovative medicines, as well as highlight key opportunities that are available throughout every step of the drug development process.
Key questions that will be answered include:
- What are the special designation opportunities and benefits from the Food and Drug Administration (FDA) and European Medicines Agency (EMA)?
- When can organizations apply for special designations?
- What are conditional marketing authorizations (EU) and when should they be discussed?
- Why are special designations and accelerated approval pathways beneficial to your drug development programs?
Founded in 2019, the Halloran Speaker Series showcases the wide range of talent and knowledge through Halloran Consulting Group’s most seasoned strategic thinkers. With thought leaders in Clinical, Quality, Regulatory, and Organizational areas, the Halloran’s Speaker Series is an interactive way to stay up-to-date on current thinking and strategies to solving some of the biggest challenges facing the life science industry today. With events hosted across the country, Halloran strives to share their expertise and collaborate with all sectors of the life science community network.