COURSE DESCRIPTION

Whether you’re in regulatory affairs, medical writing or QA, this critical course will help you prepare for the FDA’s upcoming electronic Common Technical Document (eCTD) mandate – so your marketing and investigational applications to the FDA aren’t delayed.

Host Gina Ross, a 17-year regulatory submissions expert, will cover:

  • The principles and specifications of the eCTD format through specific examples
  • How the eCTD format impacts the regulatory strategy for the FDA and global health authorities
  • Electronic initiatives at other divisions of FDA, such as the Center for Veterinary Medicine (CVM), Office of Generic Drugs (OGD) and Center for Devices and Radiological Health (CDRH)

At the end of this workshop, you’ll walk away with a better understanding of:

  • How the CTD and eCTD presentation of content impacts the decision-making process, ensuring effective implementation of regulatory strategies for global regulatory dossiers
  • Key eCTD operation attributes and lifecycle management principles, supporting global regulatory dossiers throughout the life of the dossier
  • eCTD lifecycle management, which you can apply to document authoring and regulatory dossier preparation

October
10-12,
2016

Pyle Center -
UW Madison Campus
702 Langdon St
MAdison, WI

$1,600

($1,750 after Sept. 27,2016)*

*$200 per person discount for groups or companies with two or more.

Don’t get left behind – register today!
Pharmacy Professional Development

As a top 5 School of Pharmacy that’s part of an internationally recognized research facility, University of Wisconsin-Madison, Division of Pharmacy Professional Development (DPPD) has been a leader in pharmaceutical sciences continuing education and professional development for over 65 years. And while our expert-taught programs are leading edge, you’ll have the opportunity to connect with other Midwest pharmaceutical sciences professionals at the same time.

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