We launched our CRDN Companies Forum initiative at #CRDN2016 where it was met with much interest and a number of company representatives attended a lively breakout session.
Discussion meetings on the challenges and barriers facing companies working with rare diseases, are now in development with our first formal meeting taking place on Friday 20th October 2017, at Robinson College, Cambridge prior to our annual summit.
The meeting will be conducted under the Chatham House Rule for representatives for local Pharma and biotech companies operating in the rare disease space interested in understanding the regulatory environment for orphan medicinal products. There will be a two hour workshop designed to explore the process of achieving regulatory approval for an orphan medicinal product. This will cover issues such as orphan designation and how to get it, scientific advice and protocol assistance, planning a clinical development programme when there are only a few patients across Europe, marketing authorisation and post marketing surveillance etc
The meeting will be chaired by Alastair Kent OBE, Chair of CRDN and ambador for Genetic Alliance Uk and Rare Diseases UK
9:00-9:30 Registration and coffee
9:30-10:00 Alastair Kent OBE – an overview of the Company Forum concept
10:00-12:00 Workshop led by Jordi Llinares, MD MSc, Head of Scientific and Regulatory Management, Human Medicines Evaluation Division, European Medicines Agency and Alastair Kent
A discursive workshop exploring the help and support available and the hill companies have to climb if they are to be successful in bringing an orphan drug to market. Providing an insight into the way that the Regulator approaches its task, and in so doing enabling companies to be better prepared when submitting an application for orphan designation and/or developing a clinical development plan intended to lead to a marketing authorisation.
12:00-13:00 Way forward discussion with Companies
13:00 Networking LUNCH
If your company is interested in becoming a member of the Companies Forum please contact Kay Parkinson, firstname.lastname@example.org for more information.