Conference Day One | Tuesday 8th October
8:00 Coffee & Networking
8:55 Chair’s Opening Remarks
Navigating Cross-Border, Diverse Regulations for Early Access Programmes
9:00 am Fire-Side Discussion: Harmonising European Regulations & Approaches to Compassionate Use Programs
Synopsis
- Providing an overview of alternative Pre-Approval Access pathways in Europe
- Exploring the potential for harmonizing rules across European countries and compare company practices and requirements in managing access
- Comparing the different requirements/criteria of individual patient programs versus larger group programs and the use of commercial material from different countries
- Analysing the challenges of cross-indication and off-label approval
9:30 am Interview: The Family Journey of Early Access
Synopsis
- Access to investigational medical products for treatment, outside of participation in a clinical trial, is available in most countries. Behind every request for a paediatric patient is a parent and care provider with an unabashed advocacy for their loved one
- Beyond the operational aspects of medicines delivery lies the patient and family journey
- This session will provide one mom's perspective of a 5-year family journey of early access – the uncertainties, joys and emotional experiences of investigational medicines through Early Access
10:00 am Panel Discussion: Navigating Early Access Programs in LATAM & Africa to Improve Equitability
Synopsis
- Discovering how companies establish and manage early access programs in LATAM and Africa, even without plans for commercial launches
- Identifying key regulations the industry must consider when launching and managing early access programs in these regions
- Exploring the difficulties of providing access to low-income countries and potential strategies to overcome them
10:30 Speed Networking Session
Synopsis
Join our speed networking session tailored for Early Access experts, like yourselves, to connect with fellow industry peers to facilitate rapid yet meaningful exchanges of insights and expertise. Elevate your networking experience during this session designed for impactful connecting within the space.
11:00 Morning Break & Networking
Optimizing Data Collection: Strategies & Compliance
11:30 am Optimizing Data Collection Practices
Synopsis
- Identifying the types of data that can, should, and cannot be collected for optimal research and compliance
- Learning methods for successful data collection that align with legal and ethical standards
- Exploring how data can be used or restricted in various countries, and how to navigate differing regulations
- Learning how different companies navigate the legal challenges of data collection, especially when data control and processing centres are in different countries than the program location
12:00 pm Presented by Almac
Synopsis
12:30 pm Roundtable Discussion: Regulatory Expectations for Data Collection
Synopsis
- Examine when data collection is allowed, mandated, or limited across different regulatory scenarios from the perspective of a regulatory body
- Explore methods for using collected data to interact with payers and facilitate price negotiations effectively
- Gaining insights into expectations and standards for data collection, with a focus on case studies from France for practical compliance strategies
Navigating Post-Trial Access to Ensure Continuity & Patient Care
1:00 pm Post-Trial Access: Exploring European Regulatory Considerations
Synopsis
- Highlighting what is mandated within Europe and what the landscape looks like
- Suggesting possible approaches to Post-Trial Access, such as Extension Studies, Post Study Drug Supplies/Post-Trial Access as a non-trial mechanism
1:30 Lunch Break & Networking
2:30 pm Post-Trial Access: Navigating Emerging Challenges in the Industry
Synopsis
- Explore how companies can provide continued access to medication for patients while managing the costs associated with extended studies and post-trial access programs
- Discuss strategies for addressing delays in regulatory approvals and the impact on patient access, particularly in cases of cross-border trials
- Examine the consequences of unmet post-trial access needs and explore ways to mitigate challenges for better patient equity and satisfaction
3:00 pm Post-Trial Access for Varied Product Types
Synopsis
- Examining how post-trial access programs are managed for products without approvals in any country, as well as approved but unreimbursed products
- Discussing post-trial access challenges in combination therapies and unapproved indications with approved products as disease areas evolve
- Exploring practical examples of post-trial access solutions in different countries, providing insights into strategies and regulatory considerations for various product types
3:30 pm Presented by myTomorrows
Synopsis
4:00 Afternoon Break & Networking
Empowering Patients & Advocacies: Building Stronger Connections
4:30 pm Panel Lead by Bionical Emas
Synopsis
5:00 pm Panel: Incorporating Patient & Caregiver Perspectives to Enhance Early Access Programs
Synopsis
- Delving into the processes and journeys patients and caregivers have experienced, highlighting the challenges they encountered
- Understanding how industry practices can evolve to better support patients and their families throughout the process
- Examining the burden on families and explore ways to alleviate these pressures and complexities
- Identifying strategies to make early access programs more accessible and streamline the process of connecting with knowledgeable physicians
- From a patient’s perspective, what is the best way to improve awareness around an EAPs program