5th Annual
Global Pharmacovigilance
and Risk Management
Summit
15th - 17th June 2021, 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
Sumit MUNJAL
Vice President, EU QPPV
Zakia BY
Vice President Clinical, Medical & Regulatory, Region APAC
Salvatore CICIRELLO
Sr Director Pharmacovigilance Innovation, Global Drug Safety & Risk Management
Jackie ROBERTS
Associate Vice President Scientific Affairs, Governance
Dr Dimitris ZAMPATIS
Scientific Director, Safety Strategy Lead
Some of Their Case Studies
Case Study
Day 2
Zakia BY
ice President Clinical, Medical & Regulatory, Region APAC
Novo Nordisk
Digitalization and Pharmacovigilance
How PV organizations are impacted by the increasing trend on development of digital
health solutions and customer service initiatives in pharma industry before and during
Covid time
- Supporting patients with Digital health solutions
– Global trend
– COVID-19 impacts
- Translation of the rising trend to Pharmacovigilance operations in Pharmaceutical
companies
– Operational impact
– Case volume
Case Study
Day 1
Dr Dimitris ZAMPATIS
Scientific Director, Safety Strategy Lead
MERCK
- Authorities expectation on Signal management
- Signal management and inspections
- Signal Detection using regulatory databases
- Signal detection in EVDAS
Case Study
Day 2
Jackie ROBERTS
Associate Vice President Scientific Affairs, Governance
ACCORD
Pharmacovigilance requirements post-Brexit: perspective from an exEEA QPPV
- Management of Brexit uncertainty
- UK vs Great Britain vs Northern Ireland
- Changes to reporting requirements
- QPPV and PSMF requirements
Event Sponsors
Silver Sponsor
ProPharma Group is an industry leader providing life science consulting, medical information, pharmacovigilance, and regulatory affairs services to the pharmaceutical, biotechnology, and medical device industries.
We enable clients to deliver their products to patients in the most safe, compliant, and timely manner possible. Backed by years of experience, our highly trained team understands the needs companies have in this heavily regulated environment. ProPharma Group’s experts custom tailor solutions for each of our clients based upon their unique needs and goals.
By creating an integrated compliance solution, ProPharma Group is your global, single source for the insights and services needed to maintain the highest level of value and patient safety throughout the product lifecycle. We are headquartered in Overland Park, Kansas with offices across the country, and around the world.