director clinical research and development at polpharma biologics@ Polpharma Biologics
Munich, Bavaria, Germany
Karsten Roth
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Justus Liebig University Giessen
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FlashIntel GPTKarsten Roth is a highly experienced pharmaceutical professional with over 24 years of experience in the industry. He has held international leading positions in clinical development and medical affairs across various therapeutic areas. Karsten has worked on successful development of biopharmaceuticals and biosimilars, managing clinical programs, and implementing quality management systems. He has also held positions at prestigious organizations such as Polpharma, CINFA, Sandoz, and Polpharma. With a Ph.D. in Biochemistry and a Masters in Project Management, Karsten holds a Ph.D. in Biochemistry and a Masters in Project Management.
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About
Pharmaceutical professional with more than 24 years of experience in the pharmaceutical industry, having held various international leading positions with focus on (pre)clinical development and medical affairs across several therapeutic areas. More than 13 years experience with Biopharmaceuticals and Biosimilars, including: - Successful development up to approval of a Peg-Filgrastim Biosimilar - Management of clinical programs for first and second wave Biosimilars incl. GCSF, Epo, anti TNF-alfas - Set up and submission of MAA for Biosimilars in EU and US - Presentation at EMA-, FDA- and PMDA meetings of various type - Set up of quality management systems, including SOP implementation - Set up and leading of global advisory boards Holds a Ph.D. in Biochemistry, a postgraduate Diploma in Pharmaceutical Medicine and a Masters in Project Management from the George Washington University.
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director clinical research and development at polpharma biologics
Biotechnology Research
Karsten Roth's Professional Milestones
- Head Clinical Development Hematology (2009-03-01~2013-01-01): Implementing groundbreaking technology to streamline clinical development processes and enhance patient care.
- Senior Manager Clinical Research (2001-01-01~2005-01-01): Optimized clinical research processes, significantly improving accuracy and efficiency in treatment recommendations.
Education
Philosophy,
Doctorates,
Doctor Of Philosophy,
Molecular Biology,
Biochemistry,
Masters
1985-1992Skill
Clinical Development
Clinical Trials
Drug Development
Oncology
Pharmaceutical Industry
Immunology
Clinical Research
Biopharmaceuticals
Cro
Gcp
Ctms
Ich Gcp
Hematology
Therapeutic Areas
Life Sciences
Transplant
Regulatory Submissions
Regulatory Affairs
Pharmacovigilance
Clinical Monitoring
Sop
Edc
Medical Affairs
Infectious Diseases
Clinical Operations
Biosimilars
Biotechnology
Fda
Pharmaceutics
Lifesciences
Biochemistry
Electronic Data Capture
Clinical Trial Management System
Cro Management
Medical Devices
Gmp
Certification
Colleagues
Louis Boon
Chief Strategy Officer | Board Member | JPJ Bizbiologicalsbd & Serial Entrepreneur | Founder | Speaker-Associamic Collaborator
Tirumal Rao
CDMO/CMO biologics
Jan Krzewinski
Member of the Management Board | Chief Financial Officer
Andrea Cosaro
sap key user & qc instruments owner at zambon
Joerg Windisch
President | Chief Executive Officer
Other Named Karsten Roth
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Karsten Roth works for Polpharma Biologics
Karsten Roth's role in Polpharma Biologics is director clinical research and development at polpharma biologics
Karsten Roth works in the industry of Biotechnology Research
Karsten Roth's colleagues are Louis Boon,Tirumal Rao,Jan Krzewinski
Karsten Roth's latest job experience is director clinical research and development at polpharma biologics at Polpharma Biologics
Karsten Roth's latest education in Justus Liebig University Giessen
