Module 11 2018

Module 11: The US Regulatory Environment 11 th – 13 th April 2018

Location: De Vere Latimer Estate, Chesham, UK

Module Leader(s) : Nancy Pire Smerkanich DRSc

Date: Wednesday 11 th April 2018

Chairperson

Time

Activity

Speaker

16.00

Registration

16.15 – 16.30

Welcome & Introduction to the Module

NANCY PIRE SMERKANICH

Nancy Pire-Smerkanich, DRSc International Center for Regulatory Science University of Southern California, Nancy Pire-Smerkanich, DRSc International Center for Regulatory Science University of Southern California, USA

16.30 – 17.30

Lecture 1: History and Basis of Drug Regulation in the USA

US legislative process

Role and structure of the FDA

FDA jurisdiction and statutory powers

Relevant legislation, policy and guidance documents L cture 2: FDARA, PDUFA VI and all the UFAs

17.30 – 18.30

• Background, initiatives, progress to date, issues and challenges

FDA Website Navigation

18.30 – 19.30

New Student Tutorial

USA Dr Laura Brown Course Director

19.30

Dinner

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