In the European Union (EU), the General Pharmaceutical Legislation, Orphan Regulation, and Paediatric Regulation are under revision, with numerous changes – big and small – proposed by the European Commission. These legal revisions, if adopted, will have major impacts on pharmaceutical companies doing business in the EU.
King & Spalding will host a one-hour webinar to discuss fundamental changes that the EU Commission proposes to bring to the current legal regimes and their implications. Topics for discussion will include:
- New regulatory exclusivities and incentives, including data exclusivity, orphan exclusivity, pediatric exclusivity, and vouchers for antimicrobials
- Increased requirements for environmental risk assessment (ERA)
- New requirements for critical medicinal products/shortages
- Features to streamline the approval process and support innovation
- Pediatric investigations plans, waivers, and deferrals
For questions, please contact Twilah Robinson at email@example.com