Name: #655: Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts
Start: 2026-06-17T16:00:00-0400
End: 2026-06-17T17:00:00-0400

#655: Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

201AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-640-L04-P; CME 1.00; RN 1.00

This session will assess the evolving global rare disease regulatory landscape and examine global harmonization efforts. Panelists will include leaders from FDA, EMA, NORD, Global Genes and they will discuss how get medicines to patients faster.

Learning Objectives

Describe the evolving US and EU regulatory policy landscape; Examine how to advance global harmonization efforts for rare disease drug development; Discuss the opportunities and challenges on how to get rare disease medicines to patients faster.

Chair

Emel Mashaki Ceyhan

Speaker

Panelist
Corinne de Vries, PHD, MA, MSC

Panelist
Steffen Thirstrup, MD, PHD

Speakers

Emel Mashaki Ceyhan

SVP & Head, Regulatory, Quality & Clinical Reporting (RQC), R&D, Novo Nordisk, Turkey

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →

Corinne de Vries

EMA liaison official to the US FDA, European Medicines Agency, Netherlands

Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. At EMA, she has headed the offices of Risk Management, Science and Innovation... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Rare Disease & Special Populations,Regulatory
Tags Forum

Success you have shared X tickets.

DIA 2026 Global Annual Meeting

Emel Mashaki Ceyhan

Steffen Thirstrup

Corinne de Vries

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Success you have shared X tickets.

DIA 2026 Global Annual Meeting

Emel Mashaki Ceyhan

Steffen Thirstrup

Corinne de Vries

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