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.
Munich, Germany12/1/2014 - 12/2/2014
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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Central Africa presents a number of regulatory challenges to
drug manufacturers, beginning with the complexity of dealing with the network
of many local and international organizations that provide a framework for drug
regulation. This article examines harmonization policies, defining a regulatory
submissions strategy and determinants of regulatory success in Central Africa
and provides a contact list for the 12 countries that make up the region.
Welcome to our Asia Regulatory Roundup, a new weekly overview of the top regulatory news in Asia, the Middle East and Oceania.
A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable.
The US Food and Drug Administration (FDA) plans to hold a meeting to collect public feedback on a controversial proposal to revoke a longstanding regulatory exemption for lab-developed tests (LDTs) and regulate them more like traditional medical devices.