18th October 2021
This workshop will tackle issues and potential solutions on how to conquer logistical challenges of small or geographically dispersed patient population and also limited number of investigator sites. As patient recruitment and retention is a challenge most of the sponsor are facing, there is a need for a patient-centric focus to enable patients to participate in clinical trials with less disruption to their daily routine.
WHO IS IT FOR?
This workshop is ideal for anyone who wishes to become familiar with key issues in the areas of rare diseases and orphan drugs clinical trials. It is particularly relevant to individuals working for Pharma/Biotech companies, regulatory authorities, Research and Development, patient organizations, consultancy and academic institutions.
13:30 - 15:00 PM - Interactive Presentation
15:00 - 15:30 PM - Networking Break
15:30 - 17:00 PM - Interactive Presentation & Discussion
This interactive presentation will provide you with an opportunity to learn more about how EAP’s provide pre -launch access for drugs in advance of their Marketing Authorization (MA) for patients with life-threatening conditions and no approved treatment options. Best practices in EAP planning, Set-Up and management, and provide information on current regulatory changes
WHO IS IT FOR?
This workshop will be extremely beneficial to those individuals considering an EAP as part of their drug development strategy. Project Managers and Executives in Pharma/Biotech/Advocacy interested in knowing how to set-up an Early Access Program.
13.30 - EAP Perceptions, fears, hopes & knowledge
14.00 - Case- study – High Cost / Gene THERAPY MAP
14.15 - Introduction to MAP – regulatory overview and patient and HCP perspective
15.00 - Break
15.30 - Case – study – GLOBAL CNS MAP
15.45 - Implementing a MAP
16.30 - Case – study – GLOBAL Oncology MAP
16.45 - How we go forward