1-day live online training | Starts 9:30 AM UK Time
Optimise Your Regulatory Strategies for Orphan Drugs – Click Here to Download the Agenda
No scheduled dates for this course right now — but we can deliver it exclusively for your team.
Follow the link below and complete the short form to receive a tailored course outline and clear, transparent pricing. Share your focus areas, objectives, timelines, and group size, and we’ll come back to you with a draft programme, estimated investment, and recommended next steps.
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
Orphan drugs are vital for those people with rare diseases, and this is recognised by Regulators globally. By gaining orphan drug designation, pharmaceutical companies access various incentives to encourage therapeutic development. However, it is important the system is not misused and that you fully understand the regulatory requirements and roadmap.
This training course will provide you with a comprehensive understanding of the opportunities and challenges offered by orphan drug designation. Once completed, you will understand the regulations and whether they are applicable to your product. You will also have a good understanding of the application process and procedure to obtain orphan drug designation. You will examine strategic considerations to ensure the most efficient regulatory path for your product. Learn more about how we deliver live online training.
This course is designed for professionals who need to learn more about the orphan drug designation process and is relevant for large organisations all the way to start-ups. The course is very much applicable to those involved in the regulatory roadmap of their products and include:
Course Information
13 March 2025
29 October 2025
Â
180 mins | 9:30 AM UK
Orphan medicinal product legislation
13 March 2025
29 October 2025
180 mins | 1:30 PM UK
Obtaining orphan drug designation
Orphan drug maintenance & development
Andrew Willis
Regulatory and Development consultant with 35 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.
Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.
Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. More recently for IO Biotech, Andrew was SVP of Quality, Regulatory and CMC sitting on core C-suite providing CTO support activities – overseeing all pharmaceutical development of drug substance and drug products for peptide molecules and ensuring appropriate quality systems are in place.
He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.
Discover more Pharmaceutical Training courses & Regulatory Affairs Training courses
This product has multiple variants. The options may be chosen on the product page
Individual Booking (verified owner) –
n/a
Ferronova (verified owner) –
n/a
AOP Health –
na
AOP Health –
.