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
Heike Schoepper
VP, Head of GDS-PV Management
Biopharma | Research & Development |
Global Medical Affairs and Global Drug Safety
Merck

10:30 - 11:00

How QA department can support PV department(s)
implementing the changes in regulation?

Lynn Moati
PV QA Manager, Norgine

11:00 - 11:30

Morning Coffee/Tea & Networking

11:30 – 12:00

PV Systems Inspections

Raj Bhogal Safety & International Director, Regulatory
Inspections, R&D QA & Compliance, Shire Pharmaceuticals

12:00 – 12:30

Role of Artificial Intelligence in PV
Niraj Chhaya

Lead Risk Management,
Global Pharmacovigilance
Boehringer Ingelheim

12:30 – 13:30

Networking luncheon

13:30 – 14:00

CRO'S views on PV Outsourcing ICON - Premium Sponsor of PV Europe 2018

14:30 – 15:00

Topic TBC
Dr. Dirk Schachtner
Executive Officer, Consline AG

15:00 – 15:30

Afternoon Tea/Coffee

15:30 – 16:00

Role of PV in Biologics
Mark Bailey.
Global Safety Manager, Amgen

16:00 – 16:45

Panel Discussion
PRAC Strategies to measure the Impact Factor of Pharmacovigilance

16:45 – 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

MAHs access to and obilgations in Eudravigilance, First Experiences
Bert Van Leeuwen QPPV Astellas

10:30 - 11:00

GVP IX - updates related to signal management
David Lewis Global Head of Pharmacovigilance ,Novartis

11:00 - 11:30

Morning Coffee/Tea & Networking

11:30 – 12:00

PV inspections - where are we now - GXP inspection types and
pharmacovigilance - Different inspectorates methods and approaches -
Where to next?... status quo or time for change?
Andrew Cooper PVQA Manager GQA - CDQA Pharmacovigilance QA R&D
Chief Regulatory Office GSK

12:00 – 12:30

Do we correctly communicate the risks of medicines and vaccines to the general public?
Giovanni Furlan Senior Director Pharmacovigilance & Risk Management,
EU QPPV Seqirus

12:30 – 13:00

Benefit-Risk Assessments - what is required from the regulatory perspective?
Bettina Doepner
Director, EU Therapeutic Area Lead Critical Care Global Regulatory Affairs CSL Behring

13:00 – 14:00

Networking luncheon

14:00 – 14:30

Topic TBC Tatjana Ajhler Duretek,
Head of Medical Affairs and Pharmacovigilance, Belupo

14:30 – 15:00

Topic TBC
Mircea Cicua, Head of Global Drug Safety, Vifor Pharma

15:00 – 15:30

Afternoon Tea/Coffee

15:30 – 16:00

Brexit and the Impact on Pharmacovigilance
Jackie Robert Executive Director - Regulatory,
PHV and Medical Accord Heathcare

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