Drug Development in EU: Regulatory Standards, Support and New Approaches

Successful and meaningful interactions with regulatory authorities are at the core of drug development. These include engagements on the design and approval of clinical trials, the effective use of scientific advice, leveraging regulatory support programs, understanding the intricacies of developing programs for orphan, paediatric, and advanced therapy products, and navigating approval and post-marketing activities/commitments. Modern drug development is usually a global undertaking, and as such, it is in the interest of all stakeholders to have as much alignment as possible in the different jurisdictions. Join us for this insightful workshop, where you will recognize how European regulators support drug development, marketing authorization, and market surveillance. We will address regulatory processes and explain the dual role of European regulators as gatekeepers and enablers. We will discuss established and new European regulatory approaches. Furthermore, we will talk about how the selected topics are handled in the EU and the US so that you can better appreciate the differences and commonalities between European regulators and the US FDA. We will also have time dedicated to addressing your questions and discussing potential practical scenarios.

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Workshop Agenda (Subject to Change)
*Denotes presenter(s) is providing US perspective

7:00-8:30 am
All Workshop Registrants: Registration, Continental Breakfast & Welcome

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8:30 am
Workshop Begins - Introduction

Presenter(s):
Andrea Laslop

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8:40 am
Introduction to the Legislative Background of EU Regulation of Drugs

Presenter(s):
Matthias Dormeyer
*Daniela Drago

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9:20 am
Regulatory Interactions in Scientific Advice, Joint Advice EMA-HTA/FDA and PRIME

Presenter(s):
Andrea Laslop
*Daniela Drago

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10:00 am
Moderated Q&A Session on the above Topics (EU Legislation, Scientific Advice)

Presenter(s):
All speakers as applicable and workshop participants

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10:30 - 11:00 am
All Workshop Registrants: Refreshment Break

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10:50 am
How to get and keep the Orphan Designation

Presenter(s):
Matthias Dormeyer
*Daniela Drago

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11:30 am
Challenges in Pediatric Development

Presenter(s):
Karl-Heinz Huemer
*Daniela Drago

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12:10 am
Moderated Q&A Session on the above Topics (Orphan Designation and Pediatric Medicines)

Presenter(s):
All speakers as applicable and workshop participants

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12:30 - 1:30 pm
All Workshop Registrants: Lunch

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1:30 pm
Different Pathways to Marketing Authorization including Early Access

Presenter(s):
Maria Concepcion Prieto Yerro
*Daniela Drago

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2:10 pm Use of Real-World Evidence pre- and post-authorization

Presenter(s):
Sabine Haubenreisser
*Daniela Drago

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2:50 pm
Specific Aspects and Support of Advanced Therapies

Presenter(s):
John Joseph Borg
*Daniela Drago

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3:30 pm
Moderated Q&A Session on the above Topics (Marketing Authorization, Real-World Data and ATMPs)

Presenter(s):
All speakers as applicable and workshop participants

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4:00 pm
Workshop Ends - Closure

Presenter(s):
Andrea Laslop

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