Day 1
8.30 - 9.30
Registration & Refreshments
9.30 - 9.45
Chair Person Opening Remarks
Susan Welsh MD
Chief Safety Officer, CSL Behring
9.45 - 10.30
Risk Management in PV
Heike Schoepper
VP, Head of GDS-PV Management
Biopharma | Research & Development |
Global Medical Affairs and Global Drug Safety
Merck
10:30 - 11:00
TBC
PRINCIPAL SPONSOR SLOT
11:00 - 11:30
Morning Coffee/Tea & Networking
11:30 – 12:00
PV Audits & Inspections Inspections
Raj Bhogal Safety & International Director, Regulatory
Inspections, R&D QA & Compliance, Shire Pharmaceuticals
12:00 – 12:30
Brexit and the Impact on Pharmacovigilance
Jackie Roberts
Executive Director - Regulatory,PHV and Medical - Accord Heathcare
12:30 – 13:30
Networking luncheon
13:30 – 14:00
TBC
Premium Sponsor Slot
14:00 – 14:30
GVP IX - Updates related to Signal Management
Niraj Chhaya
Lead Risk Management,Global Pharmacovigilance, Boehringer Ingelheim
14:30 – 15:00
Afternoon Tea/Coffee
15:00 – 15:30
Pharmacovigilance Operation in Affiliates: Challenges, Solutions & Strategies
Lana Gloukhova Global Head of Regions - CSL Behring | USA
15:30 – 16:30
Panel Discussion
PRAC Strategies to measure the Impact
Factor of Pharmacovigilance
16:30 – 17:00
Chairperson’s closing remarks
17:00 – 18:00
Networking Drinks Reception
Day 2
8.30 - 9.30
Registration & Refreshment
9.30 - 9.45
Chairperson's opening remarks
Susan Welsh MD Chief Safety Officer , CSL Behring
9.45 - 10.30
Future of Pharmacovigilance
Mircea Ciuca
Global Medical Head, Vifor Pharma
10:30 - 11:00
Review of the new EU Legislation on Pharmacovigilance
Bert Van Leeuwen Astellas
11:00 - 11:30
Morning Coffee/Tea & Networking
11:30 – 12:00
The Role of Regulatory Affairs in Pharmacovigilance
Kathy Wilson PV Manager QA - GSK
12:00 – 12:30
Overcome the Challenge of Managing PV Agreements Across the Enterprise and Between Third Parties
Andrew Bond
Pharmacovigilance Quality Management Specialist - Global Clinical, Safety and Pharmacovigilance
CSL Behring | Australia
12:30 – 13:00
Applying process improvement methodologies (e.g. the Toyota total quality principles) to tackle the complexities of PV regulations
Giovanni Furlan
Safety Risk Lead Director | Pfizer
13:00 – 14:00
Networking luncheon
14:00 – 14:30
Role of PSUR'S in PV Inspections
Sue Rees
EU QPPV, Executive Director, Global Patient Safety | AMGEN
14:30 – 15:00
Premium Sponsor Speaking Slot
15:00 – 15:30
Afternoon Tea/Coffee
15:30 – 16:00
Role of Artificial Intelligence in Pharmacovigilance
Bruce A Donzanti
Senior Group Director
Global Pharmacovigilance Innovation Policy
Genentech Inc., A Member of the Roche Group | USA
16:00 – 16:45
Panel Discussion & Speak Out Session - HOT Topics
Patient Support Programme
Medication Errors
Off Label Usage
16:45 – 17:00
Chair person’s closing
remarks and End of conference