TOPRA is offering a new European regulatory affairs course this month in
Philadelphia course date: April 19, 2010.
San Diego course date: April 23, 2010.
Target audience – Regulatory professionals and support staff in Regulatory Affairs and other related areas such as Medical, Manufacturing, Marketing etc. with a need to know European Regulatory Affairs. Suitable for staff in agencies and companies.
This is a new course, where you will have the opportunity to learn about European Regulatory Affairs direct from the source. These courses are limited to 30 attendees to ensure a relaxed informal environment with plenty of opportunity for interaction with the speakers.
The purpose of the day
The European Regulatory systems can be confusing and complex particularly for those not based in the European Union. The purpose of this course is to provide you with a clear and concise understanding of the European Regulatory environment including an overview of the key regulatory processes and procedures.
What you will learn
European Institutions and the European Legislative framework
European Clinical Trial Processes and Procedures
European Marketing Authorisation Processes and Procedures
The European system for classification of Post Approval Amendments
(Variations) and associated procedures.
Advertising, Labelling and Leaflets in the European Union
$400 - delegates will also receive free TOPRA membership until 1 January 2011 (Regulatory Rapporteur and InTouch Online only.)
Timings are 10 a.m. - 4 p.m. with breaks for morning coffee and lunch.
Venue:
Philadelphia, PA and San Diego, CA
Address:
Philadelphia, PA and San Diego, CA
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