
Steven Spanhaak
Apart from his specific background in the area of Immunotoxicology and significant expertise in preclinical compound development, over... | Apeldoorn, Gelderland, Netherlands
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Steven Spanhaak’s Location Apeldoorn, Gelderland, Netherlands
Steven Spanhaak’s Expertise Apart from his specific background in the area of Immunotoxicology and significant expertise in preclinical compound development, over the years Steven developed the following additional occupations/passions:1)regulatory toxicology, i.e. especially supporting the improvement of the regulatory environment, and 2)preclinical safety data management, an essential link in support of safety assessment and innovation of preclinical safety testing. During his period at Janssen/J&J (2003-2021) he has been leading several activities related to: (1) improvement of the regulatory environment, (2) global impurity management, (3) nonclinical safety data management. He held several project management positions during his 13 years (1988-2000) at TNO, where he directed research in the area of Immunotoxicology/pharmacology and headed the immunotoxicity laboratory. Thereafter, expanding his toxicological expertise in the more general direction of drug development, he held a position as Safety Assessor and Global Preclinical Project Leader in the CNS and Immunology therapeutic areas at Organon. Steven joined J&J PRD, in 2003 as a Principal Scientist in the global preclinical development organization. During the years he gradually took on and substantially expanded a leadership role in the area of regulatory toxicology. From 2004 to 2018 he has been chairing the European Federation of Pharmaceutical Industries and Associations (EFPIA) Preclinical Development Expert Group. Under his leadership this group of senior preclinical safety experts, representing the various Pharma companies in Europe, was quite successful in their interactions with Regulatory Authorities resulting in the improvement of many guidelines. Steven was the EFPIA topic leader in the ICH expert working groups that drafted the recent ICH S8 (immunotoxicity), ICH M3 (timing of required nonclinical safety studies for the conduct of clinical trials), ICH S5 (developmental toxicity testing and the ICH M7 (genotoxic impurities) guidelines. Specialties: Immunotoxicology, Safety Assessment Pharmaceuticals, Regulatory Toxicology, Impurity Management, EFPIA, ICH
Steven Spanhaak’s Current Industry D2team
Steven
Spanhaak’s Prior Industry
Isala Klinieken
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Tno Quality Of Life
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Nv Organon
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Johnson And Johnson
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Efpia
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Spanhaak Consultancy Services
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Work Experience

D2team
Senior Consultant
Sat Jan 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Spanhaak Consultancy Services
Director/Founder - Senior Consultant - Spanhaak Consultancy Services
Wed Dec 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Johnson And Johnson
Scientific Director Ncs - Global Head Regulatory Policy & Impurity Management
Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Nov 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Efpia
Chair Of The Preclinical Development Committee (Former Safety Ad Hoc Group)
Sat May 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Oct 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Johnson And Johnson
Director, Senior Scientific Advisor
Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Nv Organon
Compound Coordinator/ Safety Assessor, Department Toxicology And Drug Disposition
Sat Jan 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)
Tno Quality Of Life
Project Manager/ Laboratory Head Immunotoxicology, Division Toxicology
Fri Jan 01 1988 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time)
Isala Klinieken
Group Leader / Research Technician, Cytology Dept Clinical Chemistry Laboratory, Sophia Hospital
Sat Jan 01 1977 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 1987 00:00:00 GMT+0000 (Coordinated Universal Time)