Harpreet Ram

Company: GARDaccess

Job title: President

Seminars:

Expanded Access 101: Understanding the Basics to Plan for & Manage a First Rate Expanded Access Program 9:00 am

For many biopharma companies, there is limited internal expertise related to expanded access, which can impact operational efficiency and regulatory compliance. Designed for an audience less experienced in expanded access, this workshop will address considerations for planning and executing Expanded Access Programs by identifying strategic approaches and anticipating common challenges through a mix of practical…Read more

day: Pre-Conference Workshop Day

Expanding Patient Reach in EAPs: Overcoming Operational & Regulatory Challenges to Address Global Health Inequity related to Treatment Access 12:30 pm

Sustainability Challenge: Importance of sustainable medical access in low-to-medium income countries (LMICs) and emerging markets Stakeholders Engagement: The role of governments, NGOs, private sector, and international organizations Case Studies: Brief overview of successful models and key gaps that remain unaddressedRead more

day: Conf Day Two

Fireside Chat: Adhering to Appropriate Regulatory Guidelines to Optimize Expanded Access Programs in the US & Europe 9:00 am

Delving into the constantly changing regulatory landscape to ensure you stay ahead of the curve and are able to design compliant strategies for successful global expansion Understanding FDA guidelines for expanded access to ensure effective, streamlined operations Navigating country-level regulatory standards within Europe, addressing the opportunity for harmonization amongst distinct governing bodiesRead more

day: Conf Day One