Conference Program

Day 1

8.30 - 9.30

Registration & Refreshments

9.30 - 9.45

Chairperson’s opening remarks
Shelley Gandhi, Director, NDA

9.45 - 10.30

From Monitoring of Safety Data to Management of the Benefit-Risk Profile
Do we have a good understanding of Risks in the context of benefit?
Benefit-Risk: Does one size fit all?
Can we manage the Benefit-Risk profile of a product?
Dr Heike Schoepper, Head Global Drug Safety Regions,
Merck Serono, Germany

10:30 - 11:00

Quality Assurance In Pharmacovigilance arena
Lynn Moati
PV QA Manager, Norgine

11:00 - 11:30

Morning Coffee/Tea & Networking

11:30 – 12:00


Implementation of additional risk management measures
Dr Emanuel Lohrmann
Lead Safety Physician
Boehringer Ingelheim, Germany

12:00 – 12:30

Pharmacovigilance (PV) outsourcing standard
Can Pharmacovigilance learn from the oil and gas industry?
Bert P van Leeuwen, MD
Global Pharmacovigilance
Astellas Pharma, Netherlands

12:30 – 13:30

Networking luncheon

13:30 – 14:00

Proposed Good PV outsourcing standards
Failure is a likely to occur if cost saving is the only goal of the pharmaceutical company outsourcing its pharmacovigilance activities
Clients and service providers should understand and openly discuss each other's needs, avoiding unrealistic expectations
Clients should always have in house a pharmacovigilance expert to provide constant feedback to the service provider
Dr. Giovanni Furlan
EU QPPV Helsinn Birex Pharmaceuticals Ireland

14:00 – 15:00

Panel Discussion:
PRAC Strategy on measuring
the impact of Pharmacovigilance activities
Shelley Gandhi, Moderator
Heike Schoepper,
Head Global Drug Safety Regions,Merck Serono
Chetan Shatapathy,Director Sanjeevani and Medical Advisor Office of the QPPV Janssen Pharmaceuticals

Dr.Pipasha Biswas
Director & QPPV
Pharmacovigilance & Pharmacoepidemiology
Symogen, UK

15:00 – 15:30

Afternoon Tea/Coffee

15:30 – 16:00

An application of natural language processing for online adverse drug event monitoring
David Rozier
Group Manager and Healthcare Champion
Xerox Research Centre Europe

16:00 – 16:30

Studies for risk management and
effectiveness of risk minimisation:
meeting the challenges
Prof.Saad Shakir
Director, Drug Safety Research Unit

16:30 – 17:00

MHRA Inspection outcomes
Vaska Tone,
President & CEO,
Lava pharm USA


Chairperson’s closing remarks

17:10 – 18:30

Networking Drinks Reception

Day 2

8.30 - 9.30

Registration & Refreshment

9.30 - 9.40

Chairperson's opening remarks
Shelley Gandhi, Director, NDA

9.40 - 10.25

Signal Management - revised GVP guidance
Dr Mircea Ciuca, Head of Medical and
Clinical Drug Safety, Vifor Pharma

10:25 - 10:55

GVPs, challenges to the generic industry and how to overcome them

Is there difference in interpretation of GVP modules between generic and innovative pharmaceutical industry
Benefit-risk assessment for great number of drugs
What does signal management mean for generic industry
Challenges of risk minimization measures and safety communication for generic drugs
Dr.Tatjana Ajhler Duretek
Head Of Medical Affairs and
Belupo Pharmaceuticals

10:55 - 11:10

Morning Coffee/Tea & Networking

11:10 – 11:40

Managing Pharmacovigilance Compliance locally:
perspectives from a local affiliate

Change and Ensuring compliance
Organizational structures – what is best done locally vs globally?
Risks and benefits of a local PV function
Dr Jackie Roberts, Director of Regulatory,
Pharmacovigilance and Medical, Actavis

11:40 – 12:10

Post-Marketing Authorisation
Studies in Drug Risk Surveillance

‘PASS studies: Options and practicalities’
Regulatory aspects
Safety issues, designs and data sources
Risk minimisation evaluation studies
Data Integration
Dr Nawab Qizilbash OXON Epidemiology

12:10 – 12:40

Future Horizons and Efficiencies in Data Acquisition, Evaluation and Risk Management
Dr Flic Gabbay

12:40 – 13:30

Networking luncheon

13:30 – 14:30

Panel Discussion
- Patient Support Programme
- Medication Errors
- Off Label Usage
Shelley Gandhi, Moderator
Panelist Ashok Srivatsa, Medical Oncologist &
Chief Medical Officer, Arkaya Pharma
Dr Mircea Ciuca
Head of Medical and Clinical Drug Safety Vifor Pharma Switzerland
Dr Miranda Dollen Vice President,
Pharmacovigilance, Mapi Group MAPI Group

14:30 – 15:00

PV Audit and Inspections
Internal audit programmes – expectations for scheduling, conduct and follow-up
Regulatory inspections – thoughts on maintaining inspection-readiness, and preparing staff and documentation for inspection
Dr Miranda Dollen,
Vice President, MAPI Group, UK

15:00 – 15:30

Sponsor Speaking Slot

15:30 – 16:00

Afternoon Tea/Coffee

16:00 – 16:30

Good Pharmacovigilance and Clinical Practice”; “Challenges in Drug safety in Cancer Patients and Treatment
Ashok Srivastava
Medical Oncologist & Chief Medical Officer ARKAYA PHARMA, USA

16:30 – 17:00

Navitas Sponsored speaking slot

17:00 – 17:15

Chairperson’s closing remarks and end of conference