Original presentation date: May 2020

Overview

This webinar will provide an overview and insights into the generic drug product labelling requirements, the process for development of the label and compliance with regulations.

Learning objectives

After attending this webinar, you will be able to:  

• Differentiate between generic and branded drug labelling
• Identify the current common requirements for generic drug labelling
• Appreciate common challenges and how to maintain compliance
• Apply appropriate strategies for the submission of a generic label for authorisation
• Compare generic drug labelling requirements between EU and the US

Target audience

Regulatory affairs professionals who are looking for an introduction to generic drug product labelling.

Presenter 

Chris McGahan
Director, PRA Health Science and head of the Global Labeling Center of Excellence

Chris is a regulatory affairs professional with nearly 25 years of experience within the pharmaceutical industry and global labelling.
Areas of expertise include end-to-end drug labelling development, submission and implementation including CCDS, local prescribing/patient information labeling, and carton/container labelling. Chris specialises in structured product labelling (SPL), US labelling regulations and guidance, labelling technologies, plus global labelling processes and policies.

CPD

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

Price 

Members: £105+VAT

Non-members: £142.50+VAT

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.