Gain a comprehensive view of EU regulatory affairs for pharmaceuticals and biologics during this two-day workshop. Essential regulations, directives, and guidelines affecting Europe's regulatory system will be covered, with specific focus on development considerations, clinical trials, marketing authorization applications, post-marketing requirements, and life-cycle management.
Improve how effectively you network and advocate for yourself with ideas and techniques from this on-demand webcast.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
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When developing a regional African regulatory strategy, it is very
important to make an early determination of the key markets that will be
targeted based on the size of country vs. medical need, time to
approval, competition, language, etc. This article addresses East and
Southern Africa, as they are major markets that often follow European
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
The European Medicines Agency (EMA) has finalized a long-awaited guideline containing new recommendations on how to bring "similar biological medicinal products"—also known as biosimilars—to market in the EU.
India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on 22 October 2014 cutting the long term stability testing data requirement for active pharmaceutical ingredient (API) exports to the EU from 12 months to 6 months based on results from three batches.