Conference Day One
Tuesday, November 5th, 0019
3:05 PM Fire-Side Q&A: Post-Trial Programmes– Bridging the Gap Between Clinical Trials and Commercialisation
- Define the guiding principles that you should use to effectively manage your Early Access Programmes by comparing and contrasting methodologies from Janssen and Novartis
- Analyse the challenges that are associated with post-trial programmes and understand how you can adopt effective policies and procedures to overcome these operationally
- Developing a global framework and post trial responsibility – ensuring continued access – close access between end of trial and commercialization
Post-Conference Workshop Day
Thursday, November 7th, 0019
1:00 PM Mapping the Operational Challenges Encountered During a Complete Early Access programme, From Early Planning to Close Out
Delivering an Early Access Programme is a complex challenge, where too often the unforeseen regulatory or operational obstacles can inhibit a patient’s access to treatment. From the creation of company-wide criteria for processes and governance structures for assessing Named Patient Requests, to understanding key performance indicators, each milestone can become daunting.
Overcome the principle challenges faced from early planning to close out of an Early Access Programme by utilising the tips and tricks of Janssen, the only company world-wide to entirely centralise their Early Access Programmes, to ensure you maintain regulatory compliance throughout the timeline of an Early Access Programme.
- Assess the different operational support models and criteria to assess the model that will best fit the needs of your company
- Understand the criteria for successful management and execution of Managed Access programs
- Define the roles of various stakeholders involved across the timeline of a Managed Access Programme
- Address the operational challenges in the execution of Managed Access Programmes and consider potential mitigations
- Re-imagine the tools you are using to support the execution of Managed Access Programmes by engaging in a technology demonstration of a Software-as-a-Service platform for end-to-end management of a Managed Access Programme