4th Annual
Global Pharmacovigilance
and Risk Management
Summit
6th - 8th October 2020, Online
2 DAYS CONFERENCE + 1 DAY WORKSHOP
Some Of Our Keynote Speakers
“get inspired from the world’s leading experts”
Mircea CIUCA
Global Therapeutic Area Head - Global Clinical Safety and Pharmacovigilance
Jan STENBERG
Medical Director, Biosimilars in Nordic & CEE regions
Marion WOLF
Head | Senior Director Risk Management & Central Monitoring
Phillip EICHORN
Senior Director, Business Management, Medical & Safety
Andreas OSANGER
Director-Therapeutic Area Lead Nephrology
Colleen WALSH
Senior Director, PV and Regulatory Quality Management Operations
Salvatore CICIRELLO
Sr Director Pharmacovigilance Innovation, Global Drug Safety & Risk Management
Dr Dimitris ZAMPATIS
Associate Director Signal and Risk Management Process
Some of Their Case Studies
Case Study
Day 2
Jan STENBERG
Medical Director, Biosimilars in
Nordic & CEE regions
Biogen
Nocebo impact of PV reporting in Real World practice
- Nocebo difference impact in real World practice vs Randomized controlled
Trials - Nocebo/Placebo impact of originator vs generic/Biosimilar products safety
reporting. - Several practical experience where Nocebo play an important role in
safety/PV reporting from some of my 10 countries; (at least Iceland, Norway, Denmark and Czech) - Some innovative ideas on how to approach this topic in the future from a PVperspective
Case Study
Day 1
Andreas OSANGER
Director-Therapeutic Area Lead Nephrology
Vifor Pharma
PV best practices in 2020 and beyond: Putting a patient-centric cross-functional safety strategy in the focus!
- What we can do to increase the value of pharmacovigilance in pharmaceutical organisations?
- How drug safety will take a more pro-active role in medicines’ life-cycles?
- Why we shall set up safety strategy frameworks?
- How we are able to leverage cross-functional Benefit-Risk Management Teams?
Case Study
Day 1
Salvatore CICIRELLO
Sr Director Pharmacovigilance Innovation, Global Drug Safety & Risk Management
Celgene
Informatics technologies in Pharmacovigilance: adoption of AI and
Machine learning and the role of the Drug Safety Professional
- A framework model for leveraging PV innovation
- Development of cognitive services
- How the PV tech revolution will affect role of the drug safety professional
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