Course description
Optimising Regulatory Strategies for Orphan Drugs
This CRED course will provide a comprehensive understanding of the opportunities and challenges offered by orphan drug regulations and practical advice on how to navigate them. Although orphan drugs are designed to deliver new solutions for the treatment of rare diseases they are forecast to account for 55% of the European pipeline by 2022*. (*EvaluatePharma Orphan Drug Report 2017) This course will cover:
- Orphan Medicinal Product Legislation
- Obtaining and maintaining orphan drug designation
- Primarily focused on EU but will provide a global perspective as well
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Suitability - Who should attend?
Suitable for
- Regulatory Affairs Professionals who are interested in biotechnology and innovative medicines
- Those who are working for organisations that are targeting medicine innovation
Outcome / Qualification etc.
Benefits to participants
- Acquire key information about regulatory processes intended to expedite early access to innovative medicines
- Get practical advice on how to prepare and manage orphan submissions
- Get first-hand insights on how to get the best from orphan drug regulations
- Meet and learn from experts in the field and share the experiences of fellow participants
- Learn by doing - participate in case studies and interactive sessions
- Build a network to support the rest of your career
- Take a course designed by professionals for professionals with a proven track record
Training Course Content
- Orphan Medicinal Product Legislation
- Obtaining Orphan Drug Designation
- Maintenance of Orphan Drug Designation
- Orphan Drug Designation
Expenses
The full tuition price for Members is 550 GBP. The price for Non-members is 675 GBP
Request info
Ads