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Virtual

13 jun 2022 10:00 a.m. - 13 jun 2022 1:00 p.m.

(Eastern Standard Time)

“Has it Happened Already?” Questions of Precedent from Which Regulatory Intelligence Can Save You

Instructors

Linda  Bowen, MSc, RAC

Linda Bowen, MSc, RAC

Assistant Adjunct Temple University, Temple University Pharmacy School, United States

Linda has spent the last 30 years in regulatory strategy, policy, and intelligence roles at Seagen, Sanofi, Bayer, and GSK. She most recently was Chief of Staff, Pfizer Oncology Regulatory Strategy, a role she also had at Seagen. She has also been an Assistant Adjunct Professor in the Temple University RAQA graduate program since 1998. Linda attained Regulatory Affairs Certification for the US, Canada and Europe and was inducted into the 2011 Class of RAPS Fellows. Linda was honored with the RAPS 2020 Founder's Award and the DIA 2012, 2019, and 2022 Excellence in Volunteer Leadership Awards. She is immediate past chair of the DIA Regulatory Affairs Community and founded the DIA Regulatory Intelligence Working Group.

João  Duarte, MPharm, MSc

João Duarte, MPharm, MSc

Vice President, Global Regulatory Affairs Excellence, Ipsen, France

João Duarte is currently Director, Business Planning & Operations at Alexion, AstraZenenca Rare Disease. João serves as Chief of Staff to the Head of Regulatory & Quality Affairs and leads regulatory policy activities within the team. He held several roles since 2012 in Regulatory Intelligence & Policy, notably at Lundbeck and Takeda, where he worked to help colleagues to better understand the shifting regulatory environment and to support drug development in several therapeutic areas globally. João also worked briefly in the generics industry in Portugal and at the European Medicines Agency as a trainee.

Chris  Whalley

Chris Whalley

Senior Director and Head of Global Regulatory Intelligence, Pfizer Inc, United States

Chris Whalley brings 20 years of experience in biotechnology & healthcare operations and is currently Associate Director of Regulatory Policy & Intelligence at Seagen Inc., a biopharmaceutical company focused on oncology therapies. Prior to joining Seattle Genetics, Chris established & led the global healthcare & life sciences regulatory program at Amazon Web Services, and he previously built regulatory & quality programs at Fred Hutchinson Cancer Research Center, Amgen, and a number of pre-commercial biotech companies in the Seattle area.

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