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Dr Solange Corriol-Rohou, Senior Director, Global Regulatory Affairs & Policy, Europe, at AstraZeneca Global Medicines Development, discusses DIA's upcoming Value, Access and Regulatory Strategy event, and the value it offers to those attending the event in Hounslow from 9-10 October.

What makes the DIA Value, Access, and Regulatory Strategy 2018 Conference a must-attend event for professionals in this field?

We are in the midst of a breath-taking series of changes in the world of pharmacovigilance, both within Europe and beyond and this has prompted new challenges for all stakeholders.

The implementation of the new EudraVigilance system; re-examination of the way we assess and present safety concerns for authorized products; the intensification of evolving PV requirements in non-EU markets and the increasing complexity of business models leading to challenges in communication and oversight are just some of the things that this conference will address.

This workshop, through plenary and parallel sessions, will focus on current challenging topics within the global pharmaceutical/biopharmaceutical arena.

Attendees from the different CMC (chemistry, manufacturing and controls) areas will be able to interact with peers from Regulatory Agencies and Industry in sessions enabling interactive cross-functional discussions.

The event will held on 20-21 June 2018 at the Radisson Blu in in Basel, Switzerland.

This program was developed by the CMC Working Group of the DIA Regulatory Affairs Community.

This training will offer you the overview of the existing regulatory aspects of the CMC, and will also give you a proper understanding on how to face the challenges during the drug development and its post-approval.

For those stakeholders involved with clinical trials in Europe, the new Clinical Trial Regulation to be introduced in 2019 will have a dramatic impact. The aim of the change in regulation is to increase the efficiency of all trials in Europe, as well as promoting research while avoiding the duplication of clinical trials.