When: This is a recording of a live webinar delivered in 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 participants 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.
Speaker
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 hours for successful completion. To learn why CPD is important visit our Lifelong Learning page.
How do I register?
Prices
| Type |
Member |
Non-member |
| Standard |
£70 + VAT |
£95 + VAT |
Discounted Places
A limited number of discounted places are available at the rates below for those:
Please email meetings@topra.org for a discount code before making your booking.
| Type |
Member |
Non-member |
| Discount |
£35 + VAT* |
£47.50 + VAT* |
* VAT, if applicable, is charged at a rate of 20%.
Terms and conditions
By purchasing this webinar, you are agreeing to the terms and conditions.