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Συγγραφέας: By Various Authors
Model: RAPS1
This
comprehensive resource bundles 32 ICH guidances on pharmaceuticals and
biologics: 11 on Quality, 10 each on Safety and Efficacy, and M3 on
nonclinical safety studies.
This bundle includes:
Q1 Stability TestingQ2 Analytical ValidationQ3 ImpuritiesQ4 PharmacopeiasQ5A–Q5E Quality of Biotec..
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Συγγραφέας: By Various Authors
Model: RAPS2
For
regulatory pros working with the WHO, this bundle provides six guidance
documents addressing pharmaceuticals, medical devices, psychotropic
substances and plasma.
This bundle includes:
Recommendations for the Production, Control and Regulation of Human Plasma for FractionationConvention ..
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Συγγραφέας: By Various Authors
Model: RAPS3
This bundle comprises the pharmaceutical and biologics subsets from RAPS’ four Fundamentals of Regulatory Affairs
books: US, EU, Canada and International. The subsets review
requirements throughout the lifecycle of biopharma products, from
R&D through postmarketing requirements in these re..
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Συγγραφέας: By Various Authors
Model: RAPS4
Regulatory
professionals speak a unique language that becomes even more complex in
the international arena. RAPS’ handy guide to international regulatory
terms, definitions and acronyms will help you develop a better
understanding of the conversation.
International Regulatory Acronyms &..
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Συγγραφέας: By Various Authors
Model: 9781947493070
This
second edition includes expanded and updated risk management
information on healthcare products around the world. Before a biologic,
pharmaceutical or medical device product can be approved and marketed,
and throughout its lifecycle, the manufacturer must prove that any
risk(s) associ..
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Συγγραφέας: By Various Authors
Model: 9780997769760
Regulatory
documentation is difficult to do well. A complex field of endeavor,
regulatory writing requires knowledge about research, legal
requirements, guidance for industry and the basic ethics of drug,
vaccine, biologic and device development. Most conceptualizations of
regulatory writi..
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Συγγραφέας: By Various Authors
Model: 9781947493216
This
book comprises the pharmaceutical and biologics chapters from
International Fundamentals. It includes information on requirements,
regulations and guidances specific to these products internationally,
including an all-new chapter on pediatric drug development and more
details on regio..
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Συγγραφέας: By Various Authors
Model: 9781946493033
This edition of Fundamentals of EU Regulatory Affairs focuses
on changes to healthcare product development, manufacturing and
marketing across the EU. The most significant changes since the
introduction of the Medical Devices Directive are coming with the
implementation of the EU Medical Dev..
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Συγγραφέας: By Various Authors
Model: 9781947493179
Fundamentals of International Regulatory Affairs, Fourth Edition, has been updated and expanded to reflect the numerous changes in the worldwide regulatory environment. It includes details on requirements in more countries and regions than previous editions, details on the new EU Medical Device..
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