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
· From observation to management of risks
· Risk management in different jurisdictions
· How effective is your risk management
· What we can learn from other industries
Heike Schoepper
VP, Head of GDS-PV Management
Biopharma | Research & Development |
Global Medical Affairs and Global Drug Safety
Merck

10:30 - 11:00

Preparing and Managing Safety Data Exchange Agreements
· Legal basis for Safety Data Exchange Agreements
· Importance of SDEA
· Types of Safety Data Exchange Agreements
· How to monitor the compliance of SDEAs
· SDEAs and Inspections
· Smart Tools for monitoring and oversight of SDEAs

Pipasha Biswas
Vice President, Symogen

11:00 - 11:30

Morning Coffee/Tea & Networking

11:30 – 12:00

PV Systems Inspections
· PV System Element Ownership
· Types of PV System Inspections
· PV System Inspection Support
· Inspection Management
· Inspection Readiness
· PV System Legislation Updates
· Regulatory Agency Trends
· Consequences of Poor 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

· Are stakeholders and PV systems ready to embrace AI?
· Challenges around use of AI in PV
· Role of subject matter expert in presence of AI
Lead Risk Management,Global Pharmacovigilance, Boehringer Ingelheim

12:30 – 13:45

Networking luncheon

13:45 – 14:15

Utilising Digital Patient Experience to improve Products and Communication
Dirk Schachtner
· The increasing use of online sources for health information
· Customer Voice Monitoring: A methodology to receive meaningful customer insights from online sources
· Use case: Monitoring of patient experience with OTC drugs
Executive Officer, Consline AG

14:15 – 14:45


The new E2B R3: A reflection on experience to date
Suzanne Berresford
· Some of the challenges faced and considerations for implementation
· How does R3 compare with R2 and what are the implications during transition
· Sharing our practical experience and the potential impact on workflow
Pharmacovigilance Product Manager, Database Research Group,Springer Nature

14:45 – 15:15

Afternoon Tea/Coffee

15:15 – 15:45

Role of PV in Biologics
Mark Bailey
· Overview of biological medicines
· PV aspects specific to biological medicines
· Product traceability
Global Safety Manager, Amgen

15:45 – 16:45

Panel Discussion
PRAC Strategies to measure the Impact Factor of Pharmacovigilance

Moderator: Miranda Dollen
Vice President, Pharmacovigilance, MAPI Group
Panelist
Heike Schoepper,
VP, Head of GDS-PV Management, Biopharma | Research & Development |Global Medical Affairs and Global Drug Safety, Merck, Germany
Chetan Shatapathy,
Director, Sanjeevani and Medical Advisor Office of the QPPV Janssen Pharmaceuticals, UK
Pipasha Biswas
Vice President, Symogen, UK
Shelley Gandhi
Strategic Advisor, Pharmacovigilance & Drug Safety,NDA, UK


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
· GVP Module lX updates
· Experiences with contact with EMA about this subject
· Organisational changes to comply (the 2017 organisation in Astellas, the changes because of the Module update (staff, procedures))
· First experiences (products, results of Eudravigilance Signal Detection ‘runs’)
· Hopes and predictions for the period after this pilot (until Feb 2019)

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?
· Treatment efficacy does not only depend on the active ingredient pharmacology and on the medicinal product pharmacodynamics, but it is also influenced by patients’ expectations
· Pharmacovigilance focuses on making patients’ aware of all adverse reactions and on communicating risk minimization measures, not so much on the psychological reaction the information has on the patients
· Communications on the safety of a medicinal product should be tailored and monitored having in mind what could be the risks of patients’ overreaction to this information
Giovanni Furlan Senior Director Pharmacovigilance & Risk Management,
EU QPPV Seqirus

12:30 – 13:00

Pharmacovigilance Market Overview:
· Trends in outsourcing
· Market segments
· Outsourcing models
Oleksandr Karpenko
Pharmaceutical Physician, Olexacon, UK

13:00 – 14:00

Networking luncheon

14:00 – 14:30

All Safety Variations Sources : Keeping Generic Product Information up to date
· Legal obligation – tracking scientific knowledge
· PRAC signal recommendations
· PSUR and PSUSA recommendations
· Referrals – long story become short deadline
Tatjana Ajhler Duretek
Head of Medical Affairs and Pharmacovigilance, Belupo

14:30 – 15:00

First Three Months using EVDAS - Practical Aspects
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 Roberts 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
Moderator: Miranda Dollen
Vice President, Pharmacovigilance, MAPI Group
Panelist
Mircea Ciuca,
Head of Medical and Clinical Drug Safety, Vifor Pharma, Switzerland
Oleksandr Karpenko
Pharmaceutical physician, Olexacon, UK
Pipasha Biswas
Vice President, Symogen, UK
Shelley Gandhi
Strategic Advisor, Pharmacovigilance & Drug Safety,NDA, UK

16:45 – 17:00

Chair person’s closing remarks and end of conference