Seagen, Washington USA
Linda has 39 years' experience in the BioPharma Industry, of which 29 years were spent in regulatory affairs, the last 16 in regulatory strategy, intelligence and policy roles. She is Head of Regulatory Policy and Intelligence at Seagen Inc., formerly Seattle Genetics. She has attained regulatory affairs certification (RAC) for the US, Canada and Europe, and was an inductee to the 2011 Class of RAPS Fellows. Linda was honoured with the DIA's 2012 Excellence in Volunteer Leadership Award. Linda chairs the DIA Regulatory Affairs Community and is founder of the DIA Regulatory Intelligence Working Group. She sat on the planning committee for 2013-2017 DIA Annual Conference, the 2011-2017 RAPS Annual Convergence and is Chair of the RAPS 2019 Annual Convergence in Philadelphia, PA.
Alexion Europe SAS, France
João is currently Associate Director for Regulatory Intelligence at Alexion Pharmaceuticals, where he leads the regulatory intelligence and policy activities within the Global Regulatory Affairs team since 2018. 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, while managing the companies' European and global intelligence and policy activities. João also worked briefly in the generics industry in Portugal and at the European Medicines Agency as a trainee. João is a Pharmacist by training and holds a Master in Pharmaceutical Medicine from the Trinity College Dublin.
09:00 - 17:00 workshop(from 08:30 re...
09:00 - 17:00 workshop
(from 08:30 registration)
Dr. Henriette Wolf-Klein
Head of Department
+49 6221 500-680
After having attended this online seminar, you will be aware of the key components of RI and its practical use in your role as a regulatory professional.
This seminar focuses on the impact of regulatory intelligence (RI) on regulatory strategies.
Two seasoned regulatory intelligence professionals will address the opportunities that RI provides to organisations, as well as which intelligence skills and competencies regulatory professionals can develop in this role.
We aim at providing you with in-depth knowledge and case studies where RI can contribute to successful regulatory and development outcomes.
This seminar addresses the needs of regulatory affairs professionals directly or indirectly involved in product development and lifecycle management in the BioPharma Industry.
It will be beneficial to those interested in better understanding how to utilise regulatory intelligence (RI) to support regulatory decision-making in global regulatory strategies.
End of the seminar
Overall impression: 100 % of the participants' feedback was very good or good (July 2019)
Course content: 100 % of the participants' feedback was very good or good (July 2019)
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This was well received by the participants in July 2019
Dr. Kris Pelzer
InfectoPharm Arzneimittel und Consilium GmbH
Very interactive, only to laok more on the time (sometimes we had to run through the slides)
Interactive session, connected to others up to date information
The communication and the speaker's presentation