we will look through the orphan drug regulations in the USA and EU, we will go through these very similar regulatory areas and look at the orphan opportunities in other parts of the world. We will go through each of the requirements and look at the ways in which they can be applied to your technology and the most common errors people make when applying.
Objectives of the Presentation:
To open your eyes to new opportunities with orphan drug regulations and explain why publicly listed companies can experience a 17% share price rise overnight when orphan designations are announced.
Areas Covered:
Orphan drug regulations, EU, USA, Overview of global alternatives to orphan, benefits, technical details of applications, all you need to manage an application and the benefits.
Who will benefit:
Drug development managers, regulatory project managers, IP owners, business development directors.
Why you should attend:
Anybody who is developing a therapeutic product should consider the benefits of orphan designation, especially those that are interested in applying old drugs in new treatment or those with patents of questionable strength.
Instructor Profile
Damien has worked in the pharmaceutical industry for over 19 years, first as a pharmaceutical technician, and then as an academic research manager at SmithKline Beecham before completing his university education. Damien graduated from the University of Bradford School of Pharmacy in 2000 and has a Master’s degree in the Frontiers of Medical Science. He has since pursued his career in the development of novel drug/biological products. Damien started his post-university career working at Covance, a global contract research organisation. He worked in the global consultancy division in the area of emergent product services, specialising in defining markets and regulatory/ development strategies for novel pharmaceutical and biotechnology products. In 2004, Damien became an independent consultant in this area, specialising in working with virtual and small drug development companies. His work has seen him frequently working with regulatory agencies across the globe in order to fast-track products into Man, he develops strategies and works within the regulatory structures of the FDA, EMA, MHRA and Health Canada, amongst others. Damien also organises courses on The Regulations of First in Man Clinical Trials and Business Planning for MedTech Entrepreneurs
Live Session for one participant
Price: $225.00
Corporate Live Session 4 to 10 participants in single location.
Price:$885.00
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $275.00