genae session - The impact of the new MDR on clinical affairs - Zurich
22 June 2017
On Thursday June 22, genae is organizing a session which will provide insight to the essential changes of the new Medical Device Regulation (MDR) and the decisions your organization might face. During this interactive afternoon we will discuss among others:
-Key changes and business implications
-Impact on the clinical strategy
-Clinical evaluation and CER
Zuzanna Kwade is Sr. Clinical Safety Manager at genae and acts as an intermediary between different parties involved, incl. event committees, authorities & manufacturers.
Mieke Roelants is Sr. Regulatory Affairs Manager at genae and is involved in all regulatory-related activities incl. submissions, reimbursement & CE-marking projects.
DATE: Thursday, June 22, 2017
1.30-2.00 PM: welcome
2.00-4.00 PM: presentation (part I)
4.00-4.30 PM: break
4.30-6.00 PM: presentation (part II)
LOCATION: Holiday Inn Zürich Messe, Wallisellenstrasse 48, 8050 Zürich
The hotel is easily accessible from the airport, the highway and the main station. Please find an overview of all travel options here.
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genae session - Let’s get you ready for your clinical trial - Foster City (CA)
21 June 2017
On Wednesday June 21, genae is organizing a session which will provide insight on the most important steps in designing your clinical trial and increasing the chance of successfully bringing your product to market.
Thelma Bueno is Sr. Clinical Project Manager at genae Americas and has almost 15 years of experience in clinical research and various therapeutic areas. In her current role, Thelma is involved in the project management, study initiation and monitoring activities of medical device trials.
DATE: Wednesday, June 21, 2017
8.30-9.00 AM: welcome
9.00-12.00 PM: presentation
LOCATION: Crowne Plaza, 1221 Chess Dr, Foster City, CA 94404
The hotel is easily accessible and has free parking.
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Clinical Regulatory and Safety services
21 April 2017
genae provides a full range of regulatory support services for your pre- and post-marketing medical device development needs. Our experts adopt best practices while remaining on top of the ever-changing regulatory landscape.