CRED Life Cycle Management - Line Extensions

Aims of the course

In today’s environment, effectively managing the Life Cycle of a product is critical. This one-day workshop will provide you with a better understanding of the different aspects involved when
working with a product following its first approval, focussing in particular on Line Extensions.

Crucially, it will cover the two-way impact of commercial and regulatory issues on a product. The course will consist of presentations by key experts in the field, including group Case Studies to reinforce learnings. During the day there will plenty of opportunity to raise questions and take part in discussions with both the speakers and your colleagues.

Course content will include the following:

Overview of the post-approval product life cycle focussing on the key interaction between regulatory and commercial activities

Line extensions

● what they are and why they are done
● what type of application is needed
● planning for new indications/populations
● commercial considerations
● Regulatory Strategy
● An Agency perspective

Explanation of other essential commercial and regulatory aspects of post-approval life cycle management including:

● Parallel importation
● Data exclusivity and patents
● Supplementary Protection Certicates (SPCs)
● Licensing out
● Reclassication (e.g. Rx to OTC)
● Summary of Product Characteristics (SmPC) harmonisation

Serious negative post-marketing issues such as referrals or product recalls

Speakers include:

Kora Doorduyn, MEB, The Netherlands
Bob Clay, AstraZeneca, UK
Ann Godsell, Director, AG Regulatory
Ray Maginley, Director of Medical and Regulatory, Focus Pharmaceuticals

More speakers to be confirmed shortly

Registration: 09.00-09.30
Start of course: 09.30
End of course: 17.00