LRQA and LR Consulting are pleased to be taking part in the Drug Delivery Partnerships Europe
Conference from 17-18 September in Hamburg, Germany.
The Drug Delivery Partnerships conference is Europe's premier event, and the theme for the event this year is "collaborating to drive innovation in drug delivery".
With patent expiries of blockbuster drugs, growing demand for self-administration and the rising incidence of chronic diseases means there has never been a more important time to take advantage of the latest trends and technologies to ensure you stay ahead of the curve.
Attendees will gain valuable insights into the latest approaches; formalisations, technologies and systems to optimise their product portfolios.
Industry experts Theresa Jeary, LRQA's Technical Manager for MDD and Daniel Lock, Department Manager, Human Factors, Lloyd's Register Consulting will be presenting on the following topic at the event:
Presentation: Clarifying FDA and EU human factors guidance for drug device combination products
18 September 2014
Time: 16.00 - 16.35
This presentation will cover:
- Overview of the regulatory approval process for Drug Device Combination Products
- Essential requirements for devices
- Interpreting the FDA guidance and understanding how the FDA will judge the submission
- Putting strategies in place to decrease the likelihood of the patient having an inefficient or unsafe experience with DDCP
- Demonstrating human factors across all stages of development
- Understanding how to avoid the pitfalls and remain compliant
- An update on the human factor guidance in Europe
This is a great opportunity for you to find out how LRQA can help you meet your regulatory requirements.
To find out more about the event or to register to attend, please visit Informa