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Introduction to Medical Devices

Medicines R&D

There are currently over 500.000 types of Medical Devices and in vitro diagnostic medical devices (IVDs) on the EU market [1]. Surgical techniques and Medical Devices may seem...

Interview with Victoria Fonsou

Patient Engagement

Transcription I am a Victoria Fonsou, from Greece. I am a breast cancer patient and also a caregiver of my father, who has just been diagnosed with colon...

Women of childbearing potential in clinical trials

Medicines R&D

When women of childbearing potential are included in clinical trials, safety precautions must be taken in order to avoid the unintentional exposure of an embryo or fetus to the...

EMA Committees: Committee for Advanced Therapies (CAT)

Medicines R&D

The EMA Committee for Advanced Therapies (CAT) reviews the quality, safety, and efficacy of Advanced-Therapy Medicinal Products (ATMPs).

Clinical Trial Data Safety Monitoring Board (DSMB)

Medicines R&D

A Data Safety Monitoring Board (DSMB) is a group of independent individuals, external to the trial, who are experts in relevant areas. They review the accumulated data from clinical...

Overcoming obstacles to patient involvement in HTA

Medicines R&D

In this video, patient advocates discuss how to overcome barriers to patient involvement in HTA.

Basics of medicines regulation

Medicines R&D

Medicines regulation ensures that only sufficiently safe, effective and high quality medicines can be marketed.

Patients Involved – DevelopAKUre for AKU

Patient Engagement

Introduction An example of public-private partnership from diverse international groups in industry (Sobi), patient organisations (AKU Society and ALCAP), hospitals (Royal Liverpool, Hospital Necker, and National Institute of Rheumatic...

Interview with Karen Facey

Patient Engagement

Transcription My name is Karen Facey. I am a statistician by training. I’ve worked in drug development, medicines regulation and health technology assessment. Since being involved in health...

Mini-course starter kit- Ethics Committee

Medicines R&D

The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day...

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