Pre-Conference Workshop Day
Monday 16th October 2023
8:00 am
Registration & Welcome Coffee
Workshop A | 9:00 – 11:00 AM
9:00 am Mastering the Launch of an Early Access Programme
Synopsis
Launching a new access programme requires making multiple critical decisions. One of the most important being partnerships. When selecting vendors for an Early Access Program it is crucial to ensure that they comply with regulatory requirements and are the right fit for the programme. It is also important to choose the appropriate programme for your product, Named-Patient, Managed Access, Early Access, or Cohort. Additionally, establishing a clear and effective communication plan with all stakeholders, including patients, healthcare providers, regulatory authorities, and vendors, is vital to ensure successful implementation of the EAP. By following these strategies, you can ensure that your EAP runs smoothly and effectively, providing patients with access to potentially life-saving treatments while adhering to regulatory guidelines.
Join this workshop to:
- Discuss strategies for selecting the right vendors and ensuring they comply with regulatory requirements
- Find the best programme for your product (Named-Patient, Managed Access, Early Access, or Cohort)
- Establish a clear and effective communication plan with all stakeholders involved in the EAP, including patients, healthcare providers, regulatory authorities, and vendors
11:00 am
Morning Break
Workshop B | 11:30 AM – 1:30 PM
11:30 am Streamlining Management of Requests Through Internal Capability Development
Synopsis
This workshop aims to streamline request management through internal capability development. Participants will identify key software features for efficient request handling, including document management and decision-making processes. The workshop emphasises improving software functionality to manage exceptional requests effectively. Moreover, comprehensive training and support will be provided to internal teams to maximise software platform utilisation. By the end of the workshop gain practical strategies to enhance productivity, decision-making, and organisational capability.
Join this workshop to:
- Identify key features needed in software for efficient request management, including document management and decision-making processes
- Improve software functionality to handle exceptional requests
- Develop training and support for internal teams to effectively utilise and navigate software platforms
1:30 pm
Lunch
Workshop C | 2.30-4.30 PM
2:30 pm Effectively Collect Real World Evidence for Early Access Programmes
Synopsis
The collection of real world evidence (RWE) in EAPs can be challenging due to the complex nature of programmes and the need for comprehensive data collection. To ensure the success of an EAP while upholding patient welfare, a well-planned RWE collection process is essential.
Join this workshop to:
- Develop a comprehensive RWE collection plan that aligns with the regulatory requirements of each country in which the EAP will operate
- Coordinate internal teams to ensure effective implementation of the RWE collection plan
- Establish processes for efficiently and accurately collecting, analysing, and reporting RWE data to regulatory authorities and other stakeholders