Early Access Programmes Europe


The pharmaceutical and biotechnology pipeline has become much more specialty focused, with more and more drugs treating rare diseases now going through into main development.

In order to meet the demand for these investigational drugs and ensure an equitable supply, sponsor companies are tasked with accurately anticipating demand and strategically planning to ensure they can successfully implement and execute these early access programmes.

In addition, country-specific regulatory requirements, safety data and sufficient resources are major concerns that impact industry’s decision to run these programmes.

Pharma IQ’s Early Access Programmes Europe provides a platform to address and gain clarity of the complexities that surround EAPs.

The event features 20+ speakers from pharmaceutical and biotechnology companies as well as regulatory authorities, patient advocated and HCPS.

BUILD ON EXPERIENCES AND DEVELOP BEST PRACTICE TO OVERCOME THE CHALLENGES OF:

Understanding the types of early access programmes available and the different country regulations

Anticipating demand and make the determination to run an EAP: risk vs benefit, safety data, resources and stakeholder engagement

Developing an effective planning strategy to forecast and establish accurate drug supply

Ensuring equitable drug supply allocation

Successfully implementing, monitoring and closing out an EAP

Understanding the patient perspective and utilising independent bodies to facilitate and support EAPs

Join industry experts across Europe and the USA for three influential days of discussions that will give clarity on regulatory complexities and the challenges faced by sponsor companies.

Take advantage of this opportunity to share experiences, build on successful strategies and develop best practices.

P.S. Take a look at our resource centre to download brand new interviews with Jose Ricardo Perez, Novartis Oncology, and Kennith Moch, Former CEO at Chimerix.

Exhibitors

Anne Cropp, Vice President, Pfizer, Ramana Sonty, Director, Global Medical Organisation, Johnson & Johnson, Carlos Camozzi, Chief Medical Officer, Orphazyme, Paresh Sewpaul, Global Medical Affairs Director, Haem-Oncology Novartis, And Many More....

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