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.
IDRAC® Regulatory Online Learning provides access to relevant IDRAC documents, recognized by regulatory professionals the world over as the leading authority in respected industry information.
The latest knowledge direct to your desktop.
With IDRAC Regulatory Online Learning, you can:
- Gain a solid grounding in global regulatory affairs.
- Learn how the pharmaceutical industry operates.
- Refresh your knowledge.
- Stay on top of the ever-shifting regulatory landscape.
- Develop and implement regulatory strategies.
- Optimize your success in dealing with regulatory authorities.
- Identify potential risks to approval.
Why choose IDRAC Regulatory Online Learning?
- Comprehensive: the 22 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.
- 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: Introduction to Japanese Regulatory Institutions and Pharmaceutical Review.
- 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.
- Practical: How to Register Medicinal Products through the Centralized Procedure.
- Practical: How to Register Medicinal Products through the Mutual Recognition Procedure.
- Practical: How to Maintain Marketing Approvals in Europe for Centrally Authorized Products.
- Practical: How to Register a New Drug in the USA.
- Practical: How to Prepare for an FDA Advisory Committee Meeting.
- Practical: How to Register Medicinal Products through the Decentralized Procedure.
- 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 Submission of Investigational New Drug Applications in the USA (INDs).
- Strategic: Meeting Opportunities with Regulatory Agencies.
Contact Us
Americas
Tel: +1 800.336.4474
Tel: +1 215.386.0100
Fax: +1 215.386.2911
Europe, Middle East & Africa
Tel: +44 20.7433.4000
Japan
Tel: +81 3.5218.6500
Tel: 0800 888.8855 (free dial from Japan only)
Fax: +81 3.5218.7840
Asia Pacific
Tel: +65 6411.6888
Fax: +65 6223.2634