Expert pharmaceutical industry training from Thomson Reuters 

This modular online course 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.

• Comprehensive — the 23 modules guide you through all relevant territories worldwide
• Accurate — designed and developed by our team of IDRAC experts, assisted by an international network of consultants and partners
• Up-to-date — continuously updated to reflect the very latest developments
• Driven by you — follow the entire course as a complete guide to regulatory affairs, or drop in to the module that interests you

Regulatory Online Learning can help you to:

• gain a solid grounding in global regulatory affairs
• learn how the pharmaceutical industry operates
• refresh your knowledge or stay on top of the ever-shifting regulatory landscape
• develop and implement a regulatory strategy for your chosen markets
• optimize your success in dealing with regulatory authorities
• identify potential risks to approval and devise strategies to deal with them
• accelerate your product’s entrance into the worldwide marketplace

Course level	Course name
Introductory	Introduction to the European Union Institutions and Regulatory Authority (EMEA)
Introductory	Introduction to US Institutions and Regulatory Authority (FDA)
Introductory	Introduction to Japanese Institutions and Regulatory Authorities
Introductory	Overview of the CTD and the e-CTD
Introductory	Introduction to the International Conference on Harmonization (ICH)
Introductory	The Regulatory Development Cycle of a Drug
Introductory	Basics of Pharmacovigilance
Introductory	Basics of Clinical Trials*
Introductory	日本の薬事行政機関と規制 (Introduction to Japanese Regulatory Institutions and Pharmaceutical Review)
Practical	How to Register Medicinal Products through the Centralized Procedure
Practical	How to Register Medicinal Products through the Decentralized Procedure
Practical	How to Register Medicinal Products through the Mutual Recognition Procedure
Practical	How to Prepare for an FDA Advisory Committee Meeting
Practical	How to Register a New Drug in the USA
Practical	How to Maintain Marketing Approvals in Europe for Centrally Authorized Products
Practical	How to deal with a Pharmacovigilance Inspection*
Strategic	Regulatory Provisions for Expediting the access to Innovative Medicines in the United States and in Europe
Strategic	Access to Unapproved Drugs through Compassionate use
Strategic	Regulatory Requirements for the Conduct of Clinical Trials in Europe
Strategic	Orphan Drugs in Europe, USA and Japan
Strategic	Regulatory Requirements for the Conduct of Clinical Trials in the USA (INDs)
Strategic	Meeting Opportunities with Agencies
Strategic	Risk Management*

* These courses are currently under development

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