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AccepTher · AccepTher - Accepted Therapeutic Solutions for the pharma industry

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AccepTher Kft.

AccepTher Kft.

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AccepTher · AccepTher - Accepted Therapeutic Solutions for the pharma industry | accepther.com Reviews
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AccepTher · AccepTher - Accepted Therapeutic Solutions for the pharma industry | accepther.com Reviews

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Regulatory services - AccepTher

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Liaison with Competent Authorities. Given the complexity of industry processes leading to development and manufacture of high quality therapeutic products, which are nevertheless subject to dynamic change with the evolution of science and technological possibilities, multiple Regulatory guidance documents are intended to harmonize the requirements on both the content and the presentation of data towards Competent Authorities. Of their portfolio of pharmaceuticals.

2

Management, Dr. Botond Katona - AccepTher

http://www.accepther.com/dr-botond-katona

Is a medical doctor with a background of public health and management. He has been involved in the pharmaceutical industry since 2005, starting as a research scientist, quickly ascending to high-level positions. He has an experience in designing and managing bioequivalence trials, which resulted in many successful DCPs and MRPs. As a member of the Bioequivalence Working Group of the EGA RSAC, he contributed to the revision of the Regulatory guidance for investigation of bioequivalence.

3

Scientific services - AccepTher

http://www.accepther.com/scientific-services

Expert statements, overviews and summaries. AccepTher is acknowledged as effectively assisting its clients to identify elements of a clinical development programme suitable for European registration, the key issues for which Scientific Advice should eventually be sought, as well as key points differentiating their product from existing therapies supporting reimbursement by Health Insurance Funds. AccepTher writes and/or reviews the entire range of clinical and non-clinical documentation, from protocols.

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HU — Önéletrajz. DE — Lebenslauf. EN — Curriculum Vitae. Freelanced Trainer, Coach and Developer Consultant. Delivering Agile Frameworks – Scrum and Kanban Trainings;. Delivering Project Management Basics, and PMP Exam Prep Trainings (in English);. Training and consulting for organizational development and introduction of Agile methods throughout the country at various organizations;. Coaching; Hosting of World Café. 2014 – 2015. In Budapest, Hungary). 2013 – 2014. At Qualysoft Informatikai Zrt. Developm...

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HU — Önéletrajz. DE — Lebenslauf. EN — Curriculum Vitae. Független tréner, coach és fejlesztő tanácsadó. Agilis keretrendszerek – Scrum és Kanban Tréningek tartása;. Projekt Menedzsment Alapok, valamint PMP Vizsga-előkészítő Tréningek (angolul). Tréningek és szervezetfejlesztési, valamint Agilis módszertani tanácsadás országszerte különböző szervezeteknél. Coaching; World Café. 2014 – 2015. Két agilis team Certified Scrum Mastere a Rescue. 2013 – 2014. A Qualysoft Informatikai Zrt. 2011 – 2012. Projektek...

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AccepTher is a committed “problem-solver” company, providing acceptable solutions to optimize the way-to-market and regulatory-compliant maintenance of therapeutic products. We provide hands-on and consultancy services. Relying on the up-to-date knowledge of applicable requirements, and process know-how substantiated by working experience in product development. Documentation and registration, and regulatory life-cycle management. Of our experts, and extensive network of partners. FOLLOW US AT LINKEDIN:.

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