Conference Agenda
MUST ATTEND!
Expanded Access Programme 2022 - London, UK
Expanded Access also known by other terms such as compassionate use, early access, managed access, named-patient access, or pre-approval access is a potential pathway for a patient with an immediately life-threatening illness or severely debilitating disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) before they are reviewed and approved by a regulatory authority.
When it is not possible for a patient to participate in a clinical trial and all other available medical options have been exhausted, the patient’s physician may seek special access to investigational medicine outside of the clinical trial setting. As investigational drugs have not yet received regulatory approval, it is very important to remember that their potential risks and benefits are not yet established. In general, the person and his or her doctor must apply for access to the investigational product, the company has to choose to cooperate, and the medicines regulatory agency needs to agree that the risks and possible benefits of the drug or device are understood well enough to determine if putting the person at risk has sufficient potential benefit.
With patients thoroughly becoming knowledgeable, Pharmaceutical companies are bound to receive unsought requests. However, there are challenges and obstacles such as a diverse regulatory landscape, logistical differences, and complexities from planning an application to approval and implementation. Sponsors need to plan carefully before undertaking an Expanded Access Programme so that they have the resources, processes, and tools in place to support the inevitable demand.
The two-day Congress will provide an interactive, cutting edge, and comprehensive discussion and networking format led by key expert speakers with intimate knowledge in the industry. Gain practical strategies and best practices on challenges, innovations, technologies, and concepts in obtaining the much-needed access to these therapies for life-changing treatment.
GAIN THE LATEST INSIGHTS ON:
- The current compassionate use, or expandedaccess-related mechanisms
- The benefits and issues surrounding expandedaccess programme
- Understanding the varying regulatory landscape,policies and guidelines to ensure a smooth executionof the programme
- Criteria that must be met to authorize expandedaccess use, requirements for expanded accesssubmissions
- Understanding operational complexities, bestpractices and strategies in running a global EAP
- Successfully navigating logistical intricacies
- Incorporating patient voice from early planningto ensure a patient-centric access programme
- Engaging representatives from all stakeholdergroups to understand their perspective andexpectations of the programme
WHO SHOULD ATTEND:
- This Congress will provide information to pharmaceutical and biotech companies, researchers,physicians, institutional review boards (IRBs), patientorganisations and advocates and regulatory agenciesabout the implementation of expanded access toinvestigational drugs. Network with representativesinvolved in the following areas:
- Expanded Access
- Managed Access
- Early Access
- Market Access
- Medical Affairs
- Regulatory Affairs and Policy
- Patient Support and Patient Engagement
- Corporate Development
- RWE, and Data Management
- Quality and Compliance
- Clinical Development
- Programme Management
- Supply Chain Management
- Patient Access
- Clinical Research
- Sourcing and Logistics
- Consulting
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