Pre-Conference Workshop

ABOUT

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.

AGENDA

13:30 - 15:00 PM - Interactive Presentation 

15:00 - 15:30 PM - Networking Break

15:30 - 17:00 PM - Interactive Presentation & Discussion

ABOUT

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.

AGENDA

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

Presenter:

Durbin, a Uniphar Group