Operationalise: Early Access Programmes Summit Europe | October 18-20th, London

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!

The inaugural Operationalise: Early Access Programmes Summit Europe is the response to the industry’s plea for a greater understanding and clarity regarding the end-to-end management of running a European early access programme. With each and every speaker sharing the same desire to increase the success, ease and treatment options for patients in need, ensure that you are part of this timely conversation.

This is your only opportunity to learn from large pharma, leading biotech’s and patient advocates on key topics such as:

Ensure smooth EAP regulatory navigation with Novartis, Gensight and GSK as they share key lessons from French, British, German and emerging markets

Organise supply and anticipate demand across multiple borders in accordance with product and country specific requirements with GSK, Teva and BeiGene

Outline methods to reduce barriers for early access programmes with EURORDIS, Ataxia & Me and TheSocialMedwork to support more patient populations
Distinguish an exit strategy to end an early access programme and move to commercialisation with Merck Group

Optimise data collection and real-world data generation regulations in Europe with Secura Bio

As the demand for compassionate use, early, and managed access programmes becomes an ever-expected avenue for drug acquisition, join us to further your understanding of how to set up, operationalise, communicate, deliver and close out your altruistic programme without running into regulatory, financial or distributional challenges.

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.

Speakers: Isabelle Adeline Chief of Staff & Director Special Projects, IP & Quality Assurance MaaT Pharma, Karlijn Doorn PhD Head of Operations myTomorrows, Laura Cox Director of Partnerships myTomorrows, Jeroen van Deursen Head of Medical Affairs – Europe Secura Bio, Kirti Joshi Global Operational Lead for Tepotinib Early Access Merck Group, Soetkin Vlassak Global Medical Affairs Tepotinib Merck Group, Vilem Guryca Global Program Lead & Managed Access BeiGene, Alan Thomas The Rare Disease Warrior Ataxia & Me, Claire Wardell Director, Managed Access Global Medical Affairs GSK, Torunn Thingstad Senior Director, Global Operational Lead for Tepotinib Early Access Janssen, Veronique Ollivier-Guillon Global Program Leader Managed Access Janssen, Ana Guersoni Medical Affairs Brazil Lead CSL Behring Biotherapies, Erin Lambet Senior Director Expanded Access Program Lead Argenx, François Houÿez Treatment Information & Access Director & Health Policy Advisor EURORDIS, Sara Radenovic Associate Director, Managed Access GSK, Magali Taiel Chief Medical Officer Gensight, Ramona Reichenbach Head of Managed Access Centre of Excellence Novartis, Shirle Zajac Leader of Global Ethical Business, Shortages Response & Managed Access Programs Teva, Sjaak Vink Founder & CEO TheSocialMedwork

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