The Essentials: US Regulatory Affairs
This program will provide you with a concise, comprehensive, invaluable overview of the essentials of US regulatory affairs for the pharmaceutical, biologics, foods and dietary supplements, and medical device industries. If you are new to the regulatory profession, changing product line/industry, or preparing for the RAC examination, this program will benefit you. This workshop features a comprehensive overview of the regulations and policies affecting US regulatory affairs, an overview of the agency structures regulating these products, as well as advertising, labeling and promotion, postmarket requirements, compliance and enforcement information among other topics.


The Essentials: EU Regulatory Affairs
This workshop provides a comprehensive overview of the regulations, policies and requirements affecting the EU regulatory system with specific issues and information covering areas such as clinical trials, marketing applications, postmarketing requirements, classification, conformity assessment and technical documentation among other topics.


Combination Products: Overview and Current Status
New for 2010, this workshop will include an overview of the basics of combination product regulation. It will address various underlying issues depending on the type of product, as well as any new issues upon the Office of Combination Products (OCP) Guidance release.


Regulatory Manager Boot Camp
New for 2010, this workshop will include a range of topics critical to professionals new to the regulatory profession and those looking to improve their management skills for increased performance within their organization. This workshop will incorporate perspectives from regulatory manager and supervisors.


The Pacific Rim: Regulatory Overview and Update
NEW! This workshop will address regulatory issues and harmonization efforts that span across key Pacific Rim regions.