4th Annual International Conference and Exhibition in Pharmacovigilance, Regulatory Affairs, Risk Management and Clinical Trials

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4th Annual International Conference and Exhibition in Pharmacovigilance, Regulatory Affairs, Risk Management and Clinical Trials
Date May 22-23, 2018
Place London, UK

Pharmacovigilance Europe Congress 2018[1] attracts senior level attendees from leading pharmaceutical, biopharmaceutical, biotechnology, diagnostics, CRO and solution provider companies. Delegates includes VPs, Directors, Heads, Managers, Scientific Advisors, Consultants, Senior scientists and professionals with intermediate to advanced knowledge and experience in the following:

  • Pharmacovigilance
  • Risk Management
  • Drug Safety
  • Pharmacoepidemiology
  • Drug Research & Development
  • Clinical Pharmacology
  • Clinical Safety
  • Information and Clinical Data Management
  • Medical Product Safety Assessment
  • Clinical Research & Safety
  • Data Analysis
  • Information Technology
  • Sales and Marketing
  • Clinical Trials & CRO’s
  • Contract Manufacturing

Come and Update with the expanding Global Pharmaceutical Industry and increase awareness on the significant and essential need of Global Pharmacovigilance.

Conference Program

Day 1
8.30 - 9.30 Registration & Refreshments
9.30 - 9.45 Shelley Gandhi

Strategic Advisor, Pharmacovigilance & Drug Safety


9.45 - 10.30 Monitoring of safety data to manage the benefit-risk profile of products

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?

Heike Schoepper, MD, PhD, MBA

VP, Head of GDS-PV Management

Biopharma | Research & Development |

Global Medical Affairs and Global Drug Safety

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 RISK MANAGEMENT

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

17:00 Chairperson’s closing remarks
17:10 – 18:30 Networking Drinks Reception
Day 2
8.30 - 9.30 Registration & Refreshment
9.30 - 9.40 Shelley Gandhi

Strategic Advisor, Pharmacovigilance & Drug Safety


9.40 - 10.25 Signal Management - revised GVP guidance

Dr Mircea Ciuca, Head of Medical and

Clinical Drug Safety, Vifor Pharma



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

Managing Partner, Transcrip

12:40 – 13:30 Networking luncheon
13:30 – 14:30 Panel Discussion

- Patient Support Programme

- Medication Errors

- Off Label Usage

Shelley Gandhi, Moderator


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

Dr Oleksandr Karpenko

Managing Director

Olexacon Pharmaceuticals

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 Gain Efficiency in Pharmacovigilance: Best Practices for Literature Monitoring

Learn how breakthrough tools and processes can help pharmacovigilance departments:

1. Employ strategies to improve literature review

2. Uncover ways to reduce time spent reviewing irrelevant articles and duplicate

references to streamine the drug safety assessment process

3. Design a streamlined approach to assess safety articles for ICSRs,

aggregate reports and safety signals

4. Incorporate new techniques to focus on patient safety issues and gain

freedom from administrative burden

5. Ensure they’re always prepared for an audit

Jan Witt

Global Business & Strategy Development Manager

ProQuest Dialog

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 Challenges and success in attaining and maintaining oversight of affiliates

Jeffrey Ho, Principal, Navitas

17:00 – 17:15 Chairperson’s closing remarks and end of conference


  1. http://www.pveurope.com/

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