Center for Regulatory Excellence Series Kick Off

September 28, 2020 1:00 PM - 2:30 PM

Webinar, click "live-stream" button to view

Add to Calendar 9/28/2020 1:00:00 PM 9/28/2020 2:30:00 PM Center for Regulatory Excellence Series Kick Off

In collaboration with Bayer, MassBio is launching a Regulatory Center of Excellence. This is a new quarterly initiative to provide a forum for startups, biotechs, and research groups from academia to interact with experts on regulatory affairs. This event is meant to be an interactive platform for you to bring your key challenges to the discussion to better understand the evolving regulatory landscape. Our goal is to provide global regulatory insights on clinical development that will foster new innovative medicines for patients. Given the ongoing situation, our first event will be held virtually via Zoom.


Agenda:
1:00 - 1:05 pm     Welcome
1:05 - 1:15 pm     Introduction to the Center for Regulatory Excellence
1:15 - 1:35 pm     Engaging the US FDA on the Journey to Transforming Your Innovation Into a New Treatment Option
1:35 - 2:15 pm     Interactive Discussion

Moderators:

  • Chuck Wilson, President & CEO of Unum Therapeutics, and Chair, MassBio Board of Directors
  • Hanna Eilken, Strategic Alliances Director, Bayer


Bayer Panelists:

  • Max Wegner, SVP, Head of Regulatory Affairs
  • Chandra Ramanathan, Global Head, Pharma Research and Development Open Innovation
  • Todd Paporello, VP, Head Regulatory Affairs Americas

Please submit your regulatory questions to the panelists in advance. Questions to the group can be submitted to MassBio until September 18, 2020.

E-mail questions to innovationservices@massbio.org


The views and opinions expressed are those of the individual presenter and should not be attributed to any organization with which the presenter is employed or affiliated. Webinar, click "live-stream" button to view
SVP, Head of Regulatory Affairs, Bayer
Max Wegner is the Senior Vice President, Head of Regulatory Affairs at Bayer. In this role Max is responsible for oversight of all Regulatory Affairs activities in the Bayer Pharmaceuticals division. He started his career studying pharmacy at the University of Bonn and commenced his PhD in pharmacology at Bayer, starting in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also spent some time in China and the USA. Max led the Clinical Development organization in Pharmaceuticals Development for four years before re-joining the Regulatory Affairs organization in 2018 as head of the group. As a special Pharmacist for Drug Information, he is a member of the examination board of the Pharmacy Association Nordrhein-Westfalen. Additionally, Max is a college lecturer and speaker for various regulatory topics and he regularly speaks at/chairs various organizations meetings (DGRA, DIA, EFPIA, CIRS etc.).

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