Improve your Regulatory Intelligence (RI) Skills
Online seminar on RI and its strategic value in pharmaceutical R&D
- Key components of actionable regulatory intelligence
- Sources that support global regulatory strategy decision-making
- Using RI to maintain surveillance on the dynamic regulatory environment
- Identifying and acting on regulatory trends
- Ensuring organisations manage regulatory knowledge
This distinguishes our event
Aims and objectivesThis online 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.
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.
(from 08:30 registration)
- Defining RI and its key components; skills and competencies
- Where the need for RI in pharmaceutical industry stems from
- Main sources for regulatory information in key jurisdictions
- Public information from regulatory authority webpages
- Identifying regulatory trends
- The role of impact analysis in RI
- Regulatory guidelines and consultation procedures
- Opportunities and forums for engagement with stakeholders
- Key competitive regulatory documents of reference and other sources
- Using regulatory sources to track competitive development
- How to collaborate effectively with commercial functions
- How to effectively communicate RI within the organisation
- Tools and processes for communication; Knowledge sharing and management
- Increasingly strategic value progressing R&D towards HTA and access
- RI role in support of due diligence activities
- Artificial Intelligence and the next frontiers of RI
End of the seminar
Linda has 37 years' experience in the BioPharma Industry, of which 27 years were spent in regulatory affairs, the last 14 in regulatory policy and intelligence roles. She is Head of Regulatory Policy and Intelligence at 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.
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.
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.
You will also be able to understand the strategic importance of RI in regulatory strategies and how organisations can develop skills and competencies in support of their business.
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
This online seminar provides you within-depth knowledge on marketing authorisation, CMC documents and GMP-requirements in Russia, Belarus, Kazakhstan and Ukraine.
22. - 24.06.2020 in Online
Der Regulatory Affairs Manager ist Neuzulassungsmanager, Fristenmanager, Dokumentenmanager und Projektmanager - im Seminar bekommen Sie Tipps für die tägliche Praxis.
13. - 14.07.2020 in Online
DAS Online-Seminar zu Data Integrity, Regulatory Tracking, Compliance und Archiving - jetzt buchen!
22. - 23.06.2020 in Online
Der Online-Kompaktlehrgang für CMC-Manager in Regulatory Affairs. Sichern Sie sich Ihren Platz in unserem virtuellen Lehrgang über Zoom.
21. - 23.07.2020 in Online
Der Kompaktlehrgang für CMC-Manager in Regulatory Affairs!
01. - 03.12.2020 in Bonn