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Get up to speed on global regulatory affairs
These modular online courses will bring you rapidly up to speed on global
regulatory affairs, delivering an unparalleled depth of information and
procedural knowledge to your desktop.
Regulatory Online Learning provides access to relevant
IDRAC® documents, recognized
by regulatory professionals the world over as the leading authority in
respected industry information.
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Comprehensive — the 22 modules guide you through all relevant
territories worldwide
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Accurate — designed and developed by our team of IDRAC
experts, assisted by an international network of consultants and
partners
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Up-to-date — continuously updated to reflect the very latest
developments
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Driven by you — follow the entire course as a complete guide
to regulatory affairs, or drop in to the module that interests you
Introductory courses
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Introduction to the European Union Institutions and Regulatory
Authority (EMEA)
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Introduction to US Institutions and Regulatory Authority (FDA)
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Introduction to Japanese Institutions and Regulatory Authorities
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Overview of the CTD and the e-CTD
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Introduction to the International Conference on Harmonization (ICH)
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The Regulatory Development of a Drug
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Basics of Pharmacovigilance
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Basics of Clinical Trials
Practical courses
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How to Register Medicinal Products through the Centralised
Procedure
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How to Register Medicinal Products through the Decentralised
Procedure
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How to Register Medicinal Products through the Mutual Recognition
Procedure
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How to Prepare for an FDA Advisory Committee Meeting
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How to Register a New Drug in the USA
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How to Maintain Marketing Approvals in Europe for Centrally
Authorised Products
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How to deal with a Pharmacovigilance Inspection
Strategic courses
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Regulatory Provisions for Expediting the Access to Innovative
Medicines in the United States and Europe
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Access to Unapproved Drugs through Compassionate use
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Regulatory Requirements for the Conduct of Clinical Trials in
Europe
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Orphan Drugs in the USA, European Union and Japan
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Regulatory Requirements for the Conduct of Clinical Trials in the
USA (INDs)
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Meeting Opportunities with Agencies
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Risk Management
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Receive a quotation or product demonstration
Contact us today for more information click here.
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Further information
Click
here to
download the Regulatory Online Learning fact sheet
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