Title:
European Regulatory Affairs
Date(s) And Time(s):
Aug 9 2010 12:45PM - Aug 10 2010 4:00PM
Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
Interest Area(s):
Clinical Research,Project Management,Regulatory Affairs
Overview:
Best-Value Course on Registration Procedures in the European Union
Learn the practical side of the approval system in the European Union and how to apply the centralized mutual recognition and national registration procedures to a variety of products.
WHAT YOU WILL LEARN
· Centralized, mutual recognition, and national registration procedures in the EU
· Official regulatory policies and other issues pertinent to successful Eu regulatory strategy
· EU regulatory strategy pertinient to commercial, business, and licensing arrangements
· Trademarks and patents
· Medical devices
· Clinical trial directive
· Legal status and switching
Learning Objectives:
At the conclusion of this course, participants should be able to:
· Apply the importance of the Single Market to your studies
· Use current registration filing application procedures in the EU for various product types
· Plan for common issues and integrate solutions such as trademark and patents into your studies to ensure timelines are met
· Plan for and meet new medicines legislation for your products
· Develop protocols that ensure effective clinical trials
Target Audience:
· Regulatory affairs professionals
· Project managers
· Clinical research professionals
Event Code:
10441
Contact Information:
For detailed program information including faculty and topics, please contact:
Susan Mazak
Tel. +1-215-442-6183
Email Susan.Mazak@diahome.org
If you have not received confirmation within 5 business days, please contact:
DIA
Tel. +1-215-442-6100
Fax +1-215-442-6199
Email confirmationservices@diahome.org
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