When: This is a recording of the live webinar which took place on 26 September 2017
  

Overview 

For those individuals that are either new to the regulatory arena or have never filed an original marketing application in the US, this webinar will serve as both an introduction and an update on the national requirements for the United States. Each module of the Common Technical Document will be addressed as well as the additional electronic elements that are mandatory for a US filing and wherever there are differences with what is submitted to the EU they will be addressed.  In addition to the regulatory requirements, content such as integrated summaries/analyses, labelling and electronic data will be discussed making this webinar useful for medical writers and biostatisticians.

Learning objectives

• Introduction to the NDA/BLA Review Process.
• Administrative (Module 1) Requirements
• Module 2-5 and Key Differences between the US and EU content

• After attending you will understand the US New Drug and Biological Application requirements.

Presenters 

Nancy Smerkanich, DRSc, MS is an Assistant Professor, Clinical Pharmacy, School of Pharmacy at the University of Southern California (USC). As the former (Executive) Vice President of Global Regulatory Affairs at Octagon Research Solutions, and a senior Consultant in Regulatory Affairs at Accenture, Dr. Smerkanich was responsible for advising sponsors on regulatory filing strategy and submission development. With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas.

CPD

This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.

How do I register?

Prices

Discounted Places

A limited number of discounted places are available at the rates below for those:

• in low income countries as defined by the World Bank
• working for agencies, charities or NGOs. 

Please email meetings@topra.org for a discount code before making your booking.

* VAT, if applicable, is charged at a rate of 20%.

Terms and conditions

Please read the training terms and conditions before purchasing this webinar. By purchasing this webinar, you are agreeing to the terms and conditions.