PIER in collaboration with EIPG & UCC School of Pharmacy is delighted to organise the following webinar 'The Development & Regulatory Approval of Orphan Medicines' on Tues 15th Oct 2019 at 4pm.
Overview of Webinar
40 years ago, rare diseases and the development of medicines to treat them were not being addressed. Investment, research and development focussed on diseases where populations were large and the likely return on investment was favourable. Today, orphan medicines are rising stars. Some of the world’s best-selling medicines are for the treatment of orphan diseases. The potential return on investment is favourable and large pharma companies have grown their own and acquired rare disease companies. There are also hundreds of start-ups, blooming across the USA and Europe attracting funding and investment. This webinar will describe how legislative changes incentivised research and development in rare diseases, the pathways and procedures to develop and approve new orphan medicines and where to find trusted information. The webinar will cover the development and regulatory approval of orphan medicines in the European Union.
By the end of this presentation, you will be able to:
- Define what is meant by an orphan disease
- Define what is meant by an orphan medicine
- Understand the incentives available to develop new orphan medicines
- Appreciate the special needs for the development of orphan medicines for children
- Consider the importance of re-purposing older medicines for the treatment of orphan diseases
- Consider formulation and supply problems specific to some orphan medicines
- Understand the lifecycle of an orphan medicine, including applying for orphan designation, applying for a Marketing Authorisation application for an orphan medicine, and postauthorisation activities
- Find trusted information on orphan diseases and medicines
About the Speaker
John Watson BSc MBA MTOPRA has worked for four SME biotechnology companies and several large pharma companies. He currently works for Zogenix International Ltd as Head of Regulatory Affairs Europe. John has vast experience in the strategy, preparation, submission, negotiation of approval and maintenance of medicines regulated using the EU centralised procedure including twenty Marketing Authorisations. He has planned and managed the development and submission of eight orphan medicine applications, and many CHMP and national scientific advice procedures.
To Join the Webinar
Please register for the event by filling out the form in the attached flyer EIPG PIER Orphan Medicines Webinar_15th Oct 2019.
Further instructions will then be sent by e-mail.