Improve your Regulatory Intelligence (RI) Skills
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 objectivesThe workshop 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
10:45 Coffee break
- 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
15:30 Coffee break
- 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
17:00 End of the seminar
Linda has 35 years' experience in the BioPharma Industry, of which 25 years were spent in regulatory affairs. She consults on regulatory policy & intelligence issues and is an Assistant Professor in the Temple University RAQA Program. She was previously Head of US Regulatory Policy & Intelligence at Sanofi and has held senior regulatory positions at Bayer and GSK. 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.
Telefon: +49 69 64351 1234
After having attended this workshop, 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.
Linda & João are very good speaker. They speak lively and enthusiastic. Good knowledge, good examples. Very good preservice and voice. Good time management
MEDA Pharma GmbH & Co. KG
Good speakers, good presentation, lively conservations
Well experienced speakers, good cooperatin and coordination between both
Very familiar atmosphere, questions could be adressed every time
Strategy and methods to implent for us
Got overview and tools for regulatory intelligence
Get insights from RI from other companies - best practice
Structure of seminare content
I'm informed about the methodology of RI
Very informative. The speakers are very interactive
Great overview of RI, the importance of it
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