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Pharmacovigilance and Risk Management Strategies Conference

Agenda

Day 1 Jan 19, 2021

10:00 AM — 1:30 PM Short Course 1: Reference Safety Information

Day 2 Jan 20, 2021

10:00 AM — 1:45 PM Short Course 2: Pharmacovigilance and Risk Management Planning

Day 3 Jan 25, 2021

10:00 AM — 1:30 PM Short Course 3: Introduction to Statistics in Pharmacovigilance

Day 4 Jan 26, 2021

9:45 AM — 11:00 AM Welcome and Session 1: Keynote Address: Trustworthy Communication of Statistics and Risk in the Age of Covid
11:00 AM — 11:30 AM Networking Break
11:30 AM — 12:30 PM Session 2: Design and Conduct of COVID-19 Protocols – Implications for Efficacy and Safety
12:30 PM — 1:00 PM Networking Break
1:00 PM — 2:00 PM Session 3: Adapting Safety Data Collection and Management in Clinical Trials During a Pandemic – Potential Implications and Lessons Learned from COVID-19
2:00 PM — 2:30 PM Networking Break
2:30 PM — 3:30 PM Session 4: Assessing the Impact of COVID and Implications for Pharmacovigilance in the Future
4:30 PM — 5:30 PM DIA 2021 Exclusive

Day 5 Jan 27, 2021

10:00 AM — 11:00 AM Session 5: FDA Updates in Pharmacovigilance
11:00 AM — 12:00 PM Networking Break
11:30 AM — 12:30 PM Session 6: Asia and Latin America Region Updates
12:30 PM — 1:30 PM Networking Break
1:30 PM — 3:00 PM Session 7: Artificial Intelligence and Natural Language Processing: Offering True Benefits to PV Organizations Today
3:00 PM — 3:30 PM Networking Break
3:30 PM — 4:30 PM Session 8: REMS and RMP Effectiveness Evaluation: Industry and Regulatory Perspectives
4:45 PM — 5:30 PM Sponsored Roundtable Session

Day 6 Jan 28, 2021

8:45 AM — 9:30 AM Sponsored Roundtable Session
9:30 AM — 10:00 AM Session 9: Signaling in Eudravigilance - Where are We?
10:00 AM — 10:15 AM Networking Break
10:15 AM — 11:15 AM Session 10: European Regulatory Updates
11:15 AM — 12:00 PM Networking Break
12:00 PM — 1:00 PM Session 11: How Not to Drown in Data: Can ICH Move us Forward?
1:00 PM — 1:30 PM Networking Break
1:30 PM — 2:30 PM Session 12: Pharmacovigilance Approaches for Drug-Device Combination Products

Contact us

Registration Questions?

Send Email
1.888.257.6457

Preconference Short Courses

Short Course 1: Reference Safety Information

Short Course 2: Pharmacovigilance and Risk Management Planning

Short Course 3: Introduction to Statistics in Pharmacovigilance

On Demand Content Preview Webinar

Preparing for PV Inspections – Beyond the Basics

Additional Information

Pharmacovigilance and Risk Management Strategies Conference Resource Kit