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Virtual

Nov 29, 2021 2:00 PM - Dec 01, 2021 7:00 PM

(Central Europe Standard Time)

Clinical Trial Disclosure & Data Transparency Conference

Evolving Requirements and New Challenges

Session 3: Patients' Perspective around Disclosure

Session Chair(s)

Susan  Bhatti, PhD

Susan Bhatti, PhD

Director EU Global Regulatory and Scientific Policy, Global Regulatory Affairs

Merck BV, Netherlands

Patient access to information on clinical trials is essential so that they can be informed about the outcome of trials they have participated in as well as any options for treatment emerging from research conducted on their condition. It is important that the outcomes of research are accessible for patients in terms of the source of information and language used and that patients are confident their personal data is adequately protected.

In this session a patient representative will explain the importance of access to good lay language summaries and the need to include balanced information, including quality of life and patient reported outcome data. The importance of patient engagement and input for EMA will be presented and discussed by a member of the patient and consumer working party (PCWP).

Speaker(s)

Natacha  Bolanos

Patient Representative

Natacha Bolanos

Lymphoma Coalition , France

Global Alliances Manager

Maria  Mavris, PhD

EMA Representative

Maria Mavris, PhD

European Medicines Agency, Netherlands

Patient Relations

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