Planning for a Successful Managed or Early Access Programme
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|---|---|---|---|---|
| No sessions are planned at this time, however if you are interested in taking this course click here | ||||
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About this course
Reasons to attend
A detailed analysis of the Managed/Early Access landscape, industry trends, Clinical Trials vs. MAPs/EAPs, an assessment of the regulatory pathways and how to plan for a successful MAP/EAP.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
This course is a 3 hour webinar.Course Description
This course will include background education on the Managed Access environment, terminology, policy development, best practices, and strategic considerations. It will also cover a detailed look at regulations, supply chain considerations, Real World Data collection and launch planning. Also discussed will be when to start a Managed/Early Access Programme, feasibility, forecasting and operational considerations to ensure a successful Programme. Finally, the course will review compliant communications, patient organisation implications and protection of reputation/risk management.Programme highlight
- Overview of Managed/Early Access landscape today
- Industry trends, Clinical Operations, and feasibility of running a MAP/EAP
- Regulatory Pathways, an overview of the processes, packaging & labelling requirements for a MAP/EAP
- Roles & responsibilities, our recommendations for best practices.
- Effective management of requests for access and procedures.
- Clinical Operational considerations for a MAP/EAP and how these differ from Clinical Trials.
- Planning for a successful MAP/EAP, including RWD collection options, supply chain & strategic plans/objectives.
- Strategic Objectives Relevant to MAP/EAP
- Company launch strategy and how MAP/EAP can be a valuable component
- How the future of MAP/EAP will evolve
Learning objectives
- Understanding the main requirements for running a successful Managed/Early Access Programme.
- When a MAP/EAP is feasible and how long is the planning process
- How to link a MAP/EAP to a commercial launch strategy
- Outsourcing versus vendor partner pros and cons
Who should attend
Medical Affairs, Clinical Operations, Regulatory leads, Project Managers, Market Access, Supply Chain, Senior Commercial Leaders, and EAP Leads/Functional Team Leaders.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
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