DIA EUROPE 2020

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At the interface of two EU legislations – Multi stakeholder efforts to implement MDR Article 117 for drug delivery combinations

Session Chair(s)

Mats Ericson, PhD

Director Regulatory Affairs

Amgen, France

Armin Ritzhaupt, PhD, MPH

Scientific Administrator

European Medicines Agency, Netherlands

A growing number of new medicines are presented as single-use, prefilled, drug-delivery products. A legal requirement for a Notified Body Opinion on the device component triggered a range of questions for pharmaceutical companies, competent authorities and notified bodies. By intensive efforts by all stakeholders, the way forward is now becoming clearer.

Learning Objective : • Describe current state of play and partners in implementation from regulatory, notified body and industry perspective • Identify the challenges that have been overcome and are still remaining • Discuss approaches how expertise from both sides can be used more effectively in the future

Speaker(s)

A Notified Body approach to the new requirement

Jonathan Sutch, PhD

BSI Group, United Kingdom

Principal Medicinal Technical Specialist

The practical impact when preparing regulatory submissions

Bjorg Hunter, MSc

Novo Nordisk, Denmark

Director

What the EMA Quality guideline and Q&A document do clarify

Ivana Hayes