TMCnet News
2 Day Course: The EU Clinical Trial Regulation + EU Filings & Registrations (Opfikon, Switzerland - February 14-15, 2018) - Research and MarketsThe "The EU Clinical Trial Regulation + EU Filings & Registrations" conference has been added to ResearchAndMarkets.com's offering. This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the course will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing]. This course covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], aswell as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway. Attendees will leave the Course clearly understanding the requirements under the current Directive. In addition, this course has been updated to provide participants with competitive insight into:
For more information about this conference visit https://www.researchandmarkets.com/research/pdggll/2_day_course_the?w=4 View source version on businesswire.com: http://www.businesswire.com/news/home/20180112005177/en/ |