Due to a rapidly changing regulatory landscape in orphan drug development, innovative approaches need to be used in order to obtain regulatory approval in Europe.
Our upcoming “EU Regulatory Innovations Relevant to Orphan Drugs” webinar, presented by Steve Pinder, regulatory expert, will provide practical advice on:
- Orphan Drug Designation;
- Prime Scheme;
- ATMPs; and
- Conditional Approval.
Steve will also be available to answer any questions you may have during the Q&A session at the end of the webinar, offering you the benefit of his knowledge and experience.