Original presentation date: 9 & 16 March 2021

Overview

These webinars will provide an overview to US Marketing Applications for drugs and biologics, with a focus on US specific requirements for both content per 21CFR314 and format per ICH M4 Electronic Common Technical Document (eCTD). Participants will be introduced to organization of the FDA, and the legal framework and process for how drugs and biologics are reviewed, as well as highlight unique data and labelling specifications related to the structure of US submissions.

Learning objectives

At the conclusion of the webinar attendees will be able to:

• Discuss the evolution of regulation in the US as it applies to drug and biologic product development
• Name the relevant regulations for drug and biologic marketing applications
• Describe the review process for new drug and biologic licensure
• Differentiate the requirements for marketing applications that are unique to the US

Target audience

• Regulatory Affairs and Operations personnel, Project Managers and Clinical Operations staff involved in preparation of submission ready data and documentation.

Presenter 

Nancy Smerkanich

Nancy Smerkanich, DRSc, MS is an Assistant Professor, Department of Regulatory and Quality Sciences, in the School of Pharmacy at the University of Southern California (USC).  At USC, Dr. Smerkanich instructs on the Regulations of Drugs and Biologics, Biomedical Commerce, Regulatory Authoring, GxP Auditing and the Structure, Management, Design and Statistics of Clinical Trials.  Over her 35+ year career Nancy participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas and was responsible for advising sponsors on regulatory filing strategy and submission development.

Shannon Heacock - Senior Director, Regulatory Operations

Shannon Heacock has 15 years of experience in regulatory operations and specializes in eCTD.  Her expertise is focused on global submission management, eCTD technical requirements and data standards requirements. Throughout her career she has led teams responsible for compiling, managing and submitting thousands of investigational and marketing application submissions to the FDA, Health Canada and European health authorities in support of Centralised, Decentralised and National procedure submissions. Shannon continues to refine her knowledge through practical experience, utilizing both her operational and regulatory expertise. She consistently monitors emerging regulatory trends and participates in pilot programs and other industry initiatives to develop and document best practices and standards. Shannon frequently conducts high impact, multi-disciplinary training programs for her clients to help their cross-functional teams understand the requirements, nuances and challenges of eCTD regulatory submissions. 

CPD

This course offers 2 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.

Price 

• Members: £140+VAT
• Non-members: £190+VAT

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.

• Member: £70+VAT
• Non-member: £95+VAT 

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

Access

Once you have purchased the webinar, you will receive an email from topclass@topra.org with a link to the webinar within one hour. Once received, simply click on the link in the email to access the webinar. You will have access to the webinar for six months from the day of purchase. Please note, if you select the pay later option, you will not have access until payment has been cleared.

Terms and conditions

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