Hans Ebbers Email & Phone Number

The Hague, ZH, NL

Netherlands

Driving Biosimilar Clinical R&D strategies, including:- Preparing/Reviewing Scientific advice procedures- Protocol development for phase I PK studies and phase III clinical efficacy/safety/immunogenicity studies- Coordinating PK/Immunogenicity assay development- Coordinating immunogenicity strategy, including Integrated Summary of Immunogenicity.

Amsterdam Area

Driving Biosimilar Clinical R&D strategies, including:- Preparing/Reviewing Scientific advice procedures- Protocol development for phase I PK studies and phase III clinical efficacy/safety/immunogenicity studies- Coordinating PK/Immunogenicity assay development- Coordinating immunogenicity strategy, including Integrated Summary of Immunogenicity.

Amsterdam Area, Netherlands

Developing global medical strategies for the antiTNF portfolioGlobal publications lead Biogen biosimilars.Developing educational materialsOrganising international advisory boardsOrganising symposia at international scientific congresses

Amsterdam Area, Netherlands

Publications management, strategy and development. Medical writing and educational tools development.Internal and external scientific training

Amsterdam Area, Netherlands

Medical education in the field of biosimilars and immunology

Utrecht Area, Netherlands

Dutch Regulatory Authority,Case manager for 'FT3', which includes oncology, respiratory, bloodproducts and immunomodulators. tasks included: validating dossiers (MRP/DCP, National), coordinating CMS comments on CP products, preparing presenting dossiers for MEB meetings. Member of the biosimilar interest group.

Yeonsu-gu, Incheon, Korea

Preparing global biosimilar submissions, including EMA & FDA.CTD writing (Clinical-Non Clinicial Sections for SB2, SB4, SB5 & SB3), preparing responses to regulatory agenciesPreparing MAA Submissions, Pediatric Study Plans, developing justifications for extrapolation of indications.Based in Samsung Bioepis, Incheon, South Korea

Utrecht Area, Netherlands

Coordinating ongoing activities, present, research, development planning of a foundation associated with Utrecht University that aims to promote the development of affordable biotherapeutics for LMICs (www.uu.nl/ucab)

Utrecht Area, Netherlands

http://escher.lygature.org/Report: http://escher.lygature.org/news-events/news-events/newsitem/bericht/escher-to-present-report-at-diatopra-event-18-september-2014.html

Utrecht Area, Netherlands

Teacher of the Subjects, Disease & Medicine and Sustainable Drug Development.

Escher Project 1.3: The quality of post marketing surveillance of biotech drugspromotores: H. Schellekens, H.G.M. Leufkens, E.H.M. MoorsCo-promotor: A.K. Mantel-Teeuwisse The project aimed to study biopharmaceuticals as challenges to the regulatory system, throughanalyzing safety concerns of biopharmaceuticals and the ability of existing.

Leiden

Medical Affairs support function for infliximab (Remicade)tasks included:Support the field based clinical scientists (MSLs), the medical information centre and the marketing and regulatory affairs departments. Although trained for all indications of Remicade (Gastroenterology, Rheumatoid Arthritis and Dermatology) my main area of interest was dermatology..

Doctor Of Philosophy (Phd), Pharmaceutical Sciences

Dissertation: Biopharmaceuticals as challenges to the regulatory system. Available from.

Msc, Biomedical Sciences

Activities and Societies: Includes a 6 month internship as market researcher at the Business development department of OctoPlusScience.

Msc, Medical Biology

Activities and Societies: includes a 6 month internship at the university of Auckland (NZ)