Students on the MSc in Regulatory Affairs have free access to IDRAC, from Thomson Reuters for the first three years of their studies. This Regulatory Intelligence Solution provides professionals involved in the development, launch and post-marketing surveillance of drugs, with reliable and accurate global regulatory information to gain competitive advantage, and minimize regulatory risks.
As a comprehensive Regulatory Solution, IDRAC helps you make timely and more informed decisions by providing exclusive regulatory information for multi-country filing, comparing existing and emerging competitive products, preparing committee meetings and inspections, and keeping up-to-date on regulatory changes as they happen.
IDRAC provides you with four layers of exclusive regulatory information:
1) Global Module
The IDRAC Global Module helps you keep abreast of regulatory differences in countries and markets of your interest. This exclusive information covers a range of imperative regulatory areas including: pharmaceutical laws and regulations, electronic submissions, expected review times, clinical trial applications, fees, stability data and conditions for finished products, packaging/labelling, pre- and post -marketing pharmacovigilance, certificate of pharmaceutical products, Biosimilar products, Pharmacopeias, and more. This information can be easily compared through the use of dynamic tables, and can be filtered, sorted, and exported into Excel.
2) Regulatory Intelligence Reports
IDRAC’s regulatory specialists have developed exclusive intelligent reports to support the daily laborious task of monitoring and analyzing regulatory data, so you can spend your time making strategic decisions. Use the comparative tables within IDRAC for multi-country filing in Europe, stay ahead of EU and USA legislations and guidelines with amended versions and histories to prepare and adjust your strategic plans, compare existing or emerging competitive products using the product approval information, or identify potential new indications for your products using IDRAC’s summary table of Waivers and Paediatric Investigation Plan. You can also prepare for committee meetings and inspections with IDRAC’s committee summaries, member profiles, voting histories, and FDA inspector tables.
3) Regulatory Summaries
Use the regulatory summaries within IDRAC to support your country filings and guide you through each country’s registration process. These summaries are entirely in English, are continuously updated by our regulatory experts and local consultants, and cover the product lifecycle from development through to post-marketing. Or simply utilize the ‘How to Market’ information to help you decide the most efficient submission routes for your products.
4) Reference Documents
IDRAC provides you with a complete collection of published regulatory documents available from more than 200 sources. This repository is home to more than 90,000 documents which dates back to 1885 and is updated daily with the latest regulatory developments across the globe. The tracking of versions for documents is available through tables and hyperlinks to help you get to the information you need fast. Exclusive English translations are also available for documents in IDRAC’s China, Japan, South Korea, and Taiwan modules.
• Flexible Modular System - IDRAC allows you to choose and build the coverage that suits you from almost 70 country and regional modules.
• Alerts on changes as they happen - Set up alerts on searches and documents of your interest and receive developments and changes delivered directly to your inbox. Also register to receive the IDRAC Weekly Alert for a snapshot of the Global Regulatory landscape and to keep up with the information that matters to you most.
• Regulatory Expertise - Our regulatory editorial experts develop exclusive reports and comparative tables to support individual requirements by listening to our customer’s valuable feedback. Our local consultants can also be contacted for specific questions and individual regulatory consulting projects.
• Training - Learn from our live monthly webinars to help you gain the ultimate value from IDRAC, or use our recorded webcasts, on-site and WebEx training to meet your individual needs.
• Regulatory Online Learning - Subscribe to IDRAC ROL, our interactive and self-learning courses to bring you up to speed on global regulatory affairs.