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Markus Hartmann

“Following the evolution of research and development from a bird’s eye perspective is a highly interesting and awarding endeavor,” says Markus Hartmann. “After completing my PhD in medicinal chemistry investigating new anti-tumor agents in 1996, I was interested to learn how the molecules are then tested in humans and, later on, how all the data compiled on a new agent are compiled for marketing authorization purposes.” Having taken over roles as medical advisor in pharmaceutical corporations or as regulatory consultant serving scientific networks, Markus admits that combining scientific rigor, medical and clinical expertise, and regulatory and legal knowledge under one hat is a great challenge, but a continuously stimulating experience for his present and future work. His specific interest lies in the regulatory and legal questions that surround clinical research for drugs, devices and diagnostics.

Content by Markus Hartmann:

Business & Regulation Standards & Regulation

Clinical Compromise for Europe

| Markus Hartmann

After years of intense criticism, the European Parliament has adopted a new regulation for clinical trials that will replace the current EU Clinical Trials Directive by mid-2016.

About the Author

| William Aryitey, Ali Rajabi-Siabhoomi, Ibraheem “Ibs” Mahmood, George Mashini, Fiona Greer, Dennis Jenke, Sandy Mackay, Mark Davison, Christa Myers, Christian Schneider, Bruno Speder, Charlotte Miller, Dorina Kotoni , D. G. Joakim Larsson, Johan Bengtsson-Palme, Ann Hayes, James Strachan, Marcus Lippold, Ambuj Jain, Thomas Friedli, Christian Mänder, Tim Sandle, James Ritchie, Mark Davison, Aad van de Leur, Christoph Herwig, Harparkash Kaur, Doug Hausner, Prashant Yadav, Andreas Seidel-Morgenstern, Peter Seeberger, Abbe Steel, James Humphrey, Sam Salek, Prashant Yadav, Fiona Greer, Arun Giridhar, Elçin Içten, Laura J. Hirshfield, Susan Dexter, Joshua Cohen, Jon Platt, Seth Lederman, Dennis Åsberg, Rob Bragg, Natalie Privett, Helen Sammons, Daniele Piergentili, Leena Otsumaa, Ronak Savla, Charlotte Miller, Andy Wells, Jan Gunnar Gustafsson, Michael Leane, Claire Thompson, Nicolas Ponce, Christian Mänder, Thomas Friedli, Duncan Emerton, Rafel Prohens, Christopher A. Hunter, Vikramaditya G. Yadav, Richard Fazackerley, Keith Williams, Christian Hay, Lee DesRosiers, Susana Da Silva Torres, Mark R. Taylor, Catherine Akers, Jaime Marach, Jenny Walsh, Steve Thomas, Ayman Chit, Carsten Brockmeyer, Eric Byres, Joel Langill, George Scott, Lynn Baird, Mike Rozembajgier, Iain Moore, Jeanne Moldenhauer, Mark J. Roberts, Gabrielle Cosel, Allan Coukell, Tracey Guise, Mick Foy, Guillaume Plane, Gert Moelgaard, Faiz Kermani, Tim Sandle, James Agalloco, Markus Hartmann, Charlotte Barker, Stephanie Vine

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