Successfully Navigate the Complex European Regulatory Landscape & Conquer Operational Hurdles to Provide European Patients Early Access to Medicine

Confidently Navigate Evolving European Regulatory Policies & Robustly Drive Data Collection to Support Drug Development & Reduce Barriers to Entry for Early Access Programmes to Bring Life Saving Treatments to Patients More Efficiently

Europe currently has over 100 early and managed access, compassionate use, and named patient programmes running across the continent. However, the multi-layered regulatory frameworks that require both EMA and country-specific legislation mean that getting pre-approved drugs to European patients is fraught with operational challenges.  

On the back of several years of successfully running the US Operationalize: Expanded Access Programs Summit, we are extremely excited to bring you the European version this October!  

By uniting Europe’s leading Early Access Programme thinkers, this exclusive platform will clarify the complex issues through end-to-end Named Patient and Compassionate Use programme operationalisation. Through open discussion, sharing best-practice case studies, and removing hypotheticals, this meeting will provide an unrivalled opportunity to solve your challenges across the entire timeline such as navigating European regulations, product labelling requirements and closing an early access programme.  

Whether you’re a veteran at managing early access programmes and are looking to expand your geo, or a new entrant to the field, you’ll leave this conference with the practical lessons and essential connections needed to supercharge your European early access programme across 2022 and beyond.  

Download the Full Event Guide to find out more

A Snapshot of our Expert Speaker Faculty:

Magali Taiel

Chief Medical Officer

Gensight

Ramona Reichenbach

Head of Managed Access Centre of Excellence

Novartis

Sara Radenovic

Associate Director, Managed Access

GSK

Shirle Zajac

Leader of Global Ethical Business, Shortages Response & Managed Access Programs

Teva

Sjaak Vink

Founder & CEO

TheSocialMedwork

Companies Attending Include:

Companies Attending