Conference Program


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