Conversations in Drug Development

A Guide to Marketing Authorization Applications in Europe


Listen Later

In this episode, host Harriet Edwards is joined by Dr Katherine Bowen to explore the regulatory fundamentals for obtaining marketing authorization in Europe, focusing on the centralised procedure. Together, they unpack the intricacies of this pathway, comparing it to the FDA application process and emphasising the critical role of thorough dossier preparation and clear communication with regulatory authorities. Key topics include the importance of early engagement with regulators, navigating the challenges of Module 1, developing risk management plans, and addressing current regulatory issues.

...more
View all episodesView all episodes
Download on the App Store

Conversations in Drug DevelopmentBy Boyds

  • 5
  • 5
  • 5
  • 5
  • 5

5

3 ratings


More shows like Conversations in Drug Development

View all
Economist Podcasts by The Economist

Economist Podcasts

4,278 Listeners

Freakonomics Radio by Freakonomics Radio + Stitcher

Freakonomics Radio

32,260 Listeners

Two Scientists Walk Into a Bar by Genentech

Two Scientists Walk Into a Bar

309 Listeners

Up First from NPR by NPR

Up First from NPR

56,221 Listeners

JAMA Medical News by JAMA Network

JAMA Medical News

90 Listeners

The Long Run with Luke Timmerman by Timmerman Report

The Long Run with Luke Timmerman

122 Listeners

The Readout Loud by STAT

The Readout Loud

318 Listeners

The Journal. by The Wall Street Journal & Spotify Studios

The Journal.

5,937 Listeners

SCRS Talks by Society for Clinical Research Sites

SCRS Talks

0 Listeners

Business Of Biotech by Ben Comer

Business Of Biotech

88 Listeners

Pharma Market Access Insights - from Petauri Evidence by Petauri Evidence

Pharma Market Access Insights - from Petauri Evidence

2 Listeners

Raising Health by Andreessen Horowitz, a16z Bio + Health

Raising Health

147 Listeners

From Lab to Launch by Qualio by Qualio

From Lab to Launch by Qualio

8 Listeners

Transformation in Trials by Sam Parnell & Ivanna Rosendal

Transformation in Trials

0 Listeners

Business Of Biotech by Ben Comer

Business Of Biotech

88 Listeners