News & Analysis on Clinical Trial Services & Contract Research And Development
CTI Clinical Trial and Consulting Services
By Melissa Fassbender
- Last updated on
Günter Stetter has been promoted to vice president, global regulatory affairs study start up.
In his new role, Stetter said his main goal is global harmonization.
"Regulatory requirements are significantly different in each of the countries and regions in which CTI is active, and each of our regional regulatory teams currently do a great job of navigating the processes and requirements for our partners," he told us.
"My goal is to work with all of our teams together on a global level to further improve upon our processes and identify ways to make the submission processes even faster and more efficient.
"I anticipate a lot of challenging activities as I take on the role, such as the ramifications of Brexit and the implementation of EU Regulation 536/2014, but I have a wonderful team of talented people working with me and I am looking forward to these challenges.”
Stetter has been with CTI since 2010 and has more than 30 years of clinical, academic, and industry experience. Before his time at CTI, he was the director of clinical operations at AAIPharma Deutschland GmbH & Co. KG Neu-Ulm.
He has also worked for Rentschler Biotechnologie GmbH and Rentschler Arzneimittel GmbH & Co. KG.