Fit for the USA

Christoph Klaus, Managing Director Medical Technology

Growth in the USA - But how?

Healthcare companies in Europe must deal with the largest national healthcare market, the USA, as part of their individual growth strategy. This usually also involves examining whether the USA is seen purely as a sales market or if value creation is also allocated there.
In any case, it is essential to understand the requirements of the local regulatory authority, the Food and Drug Administration (FDA), and their impact on your own company.

The course is specifically designed for decision-makers who want to understand the context and structure of an FDA audit in a concise format.

Advantages:

- 14 days after this program, each participant will receive a personal written recommendation for their specific questions if desired.
- The speaker is available both the evening before and on the evening of the event for individual questions.

Case studies of FDA inspections in 2013 and 2014 involving international companies from pharma, medical technology, and diagnostics in the D.A.CH region: Germany, Austria, Switzerland

Goals:
• Gain an understanding of the structure and processes of the FDA.
• The target audience is management with a solid understanding of operational topics.
• Recognize FDA requirements through case examples and practical tips.

Target Group:
• Executives
• Managing directors, plant managers, board members, private equity fund managers

Features:
• Senior managers experienced with FDA, BfArM, and ICH Q10
• Case studies of FDA inspections in 2013 and 2014 involving international companies from pharma, medical technology, and diagnostics in the D.A.CH region: Germany, Austria, Switzerland

Industries:
• Medium-sized companies with exports to the USA
• Corporate-affiliated companies
• From pharma, diagnostics, and medical technology