Global Regulatory Strategies
Date and Time
Thursday Feb 18, 2021
6:30 PM - 8:00 PM EST
February 18
6:30 - 8:00 p.m.
Location
Zoom
Fees/Admission
To register, click here.
Website
Global Regulatory Strategies
Description
Birgitta Hedin, head, global regulatory affairs - rare diseases, Chiesi Group
The presentation will focus on regulatory's role in product development and development of global regulatory strategy to aid company objectives. A comprehensive strategy includes regulatory intelligence, consultation strategy (with regulators), risk assessment, Target Product Profile (TPP), label and much more. Birgitta believes the aim of a global regulatory strategy is to “find a way through the regulatory jungle, satisfying different customer needs in the shortest timeframe possible”.
Birgitta Hedin has extensive experience in global regulatory affairs, having worked at Astra Zeneca, Boehringer Ingelheim, CSL Behring and several other companies before making Chiesi her current home. She has also served in the capacity of Asian Regulatory Strategy Director based in Japan. Birgitta’s expertise is in ensuring regulatory strategies are developed clearly in line with product development objectives. Currently, Birgitta is developing and expanding the rare diseases effort at Chiesi Group.
