European Regulatory Procedures 2017
About This Event
Course "European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements and other Agencies" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
• EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines.
• In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines.
• EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission, the medicines regulatory authorities in the European Economic Area countries, and EMA. Working together has encouraged the exchange of knowledge, ideas and best practices, to ensure the highest standards in medicines regulation.
• Today, seven EMA scientific committees and more than 30 working parties provide scientific expertise for the regulation of medicines by drawing on a pool of several thousand European scientific experts from the network.
• And Much More...
Why should you attend:
• What is EMA and the overall process with CP, MRP, DCP and other interactions with agencies?
• Identify the challenges to global submissions management presented by EU versus US key differences
• Understand the EU legislative environment and the key EU Directives and Regulations relating to human medicines and for strategic regulatory intelligence decision-making
• Identify and address challenges and pain points to the global submissions management process and making critical regulatory decisions based on EU versus US differences
• Demonstrate knowledge on navigating the regulatory process through EMA regulations and inspection guidelines regarding submissions
• Learn more about and how to apply the different types of procedures for authorization
• If "full/usual" authorization not possible, several options exist
Location: Zurich, Switzerland Date: August 28th & 29th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50
Price:
Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate)
Until July 15, Early Bird Price: $1,695.00 From July 16 to August 26, Regular Price: $1,895.00
Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*
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