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
The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year.
A new report published by Georgetown University with support from a US Food and Drug Administration (FDA)-funded project calls for wider sharing of regulatory data in the hopes of enhancing the development of new products.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.