6th Annual World Life Sciences Conference
1 Jun - 2 Jun 2018
Session information
Committee(s)
Intellectual Property and Entertainment Law Committee
(Lead)
Life Sciences Subcommittee
(Lead)
Description
In the wake of an increasing amount of off-label uses and recommendations, the following paramount questions arise: Can the importance of a marketing authorisation be disregarded, mostly for cost-related issues? Is off-label a relevant comparator from the pricing and reimbursement perspective? Can a product used off-label be considered as a competitor for purposes of market definition? What other implications are there from the regulatory, commercial and antitrust angle?
Session / Workshop Chair(s)
| Natalia Castro | Raisbeck & Castro, Bogota, Colombia |
| Helen Waxberg |