



The opening session will focus on the European Commission’s Pharmaceutical Strategy and how legislative and regulatory amendments can deliver better access and supply of medicines.
In this session we will discuss global convergence efforts for generic medicines, looking at the current legal framework and the way forward. We will explore the opportunities provided by parallel EMA/FDA Scientific Advice and how new approaches to bioequivalence can open the door to a new era in generic development, access and availability.
The session will focus on necessary changes to MA procedures: modernise the DCP/ RUP; changes to CP, self-standing ASMF assessment, variations to support the Pharma Strategy objective to optimise the regulatory processes and deliver on faster patient access to medicines.
We will discuss the developments in pharmacovigilance and understand how a global view of patient safety can impact day to day practice and implementation.
This session will look at advancing digitalisation to achieve interoperability and successful digital transformation for a truly integrated regulatory system.
This session will recap the key solutions and benefits for access and supply discussed in the conference and look at how to prioritise the reform agenda in line with the ambitious vision of the Pharma Strategy. One objective will be to align regulatory and industry timelines to deliver as quickly and efficiently as possible.
Lucia Romagnoli
M: +39 345 217 7722
For more information on sponsorship packages:
Trudy Beks
M: +31 6 4119 0824
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For any other media enquiries:
Kate O’Regan
P: +32 (0)2 239 2019