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In such turbulent times, pharmacovigilance has been also affected by the unexpected changes of the World. BREXIT and Trump tornado, what else to come? In order to stay up-to-date our 5th Annual Pharmacovigilance Forum is a perfect opportunity to hear the most important updates of the industry. We bring together the top minds of the pharmaceutical industry from all over Europe to share their experiences and best practices and to network with their peers. Topics such as BREXIT vs. Pharmacovigilance, effectiveness evaluation of risk minimization measures, signal detection and Eudravigilance, GVP guidance, significance of outsourcing and many more will be discussed and consulted during our event. For those interested in Biosimilars Dr. Niraj Chhaya from Boehringer Ingelheim GmbH will present the success factor of biosimilars.

We are also happy to welcome Andrew A. Parsons on board from Reciprocal Minds Limited who will talk about human factors in Pharma R&D. This is a special feature to the event which will be a great added value to the audience.
Stay up-to-date and join our upcoming event to meet these leaders of the industry and listen their inspiring presentations in order to take home the most beneficial outcome for you and your company.

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Event schedule

Day one

  • 08:30 Welcome Coffee and Registration

  • 09:00 Pharmacovigilance in the light of BREXIT

  • 09:40 An overview of EMA MLM’s method of literature monitoring

  • 10:20 Switzerland- still a special country; Tips for an successful Pharmacovigilance Inspection

  • 11:00 Tea, Coffee, Networking & Exhibits

  • 11:30 Practical advice on the planning and conduct of
    Pharmacovigilance audits in small and medium-sized
    enterprises (SMEs)

  • 12:10 Current regulatory trends in PASS and PIP studies

  • 12:40 Effectiveness Evaluation of Risk Minimization Measures: a Case Study

  • 13:30 Luncheon & Networking

  • 14:30 Reclassifying medicines for OTC: Assessing benefit-risk and risk minimization in a consumer setting

  • 15:10 Human Factors – Optimising the usability of processes and technology in Pharma R&D

  • 15:50 Tea, Coffee, Networking & Exhibits

  • 16:20 Why does pharmacovigilance sometimes fail and where could the fault lie?

  • 17:00 Pharmacovigilance of Antibiotics

  • 17:40 Closing Remarks from the Chair & Networking

Day two

  • 08:30 Meet, Greet & Networking with Welcome Coffee

  • 09:00 Signal Detection an Eudravigilance

  • 09:40 Signal Management – revised GVP guidance

  • 10:20 Web-based signal detection

  • 11:00 Tea, Coffee, Networking & Exhibits

  • 11:20 Pharmacovigilance : The patient Perspective

  • 12:10 Safety aspects of Patient Support Programmes and other Customer Engagement Activities

  • 12:50 Luncheon & Networking

  • 13:50 Pharmacovigilance for Biosimilars

  • 14:30 Significance of outsourcing and its effectiveness

  • 15:10 Tea, Coffee, Networking & Exhibits

  • 15:40 Safety Alerts: An Observational Study

  • 16:00 Holistic Approach to Combination Product Safety

  • 17:00 Closing Remarks from the Chair & Farewell Networking


Become a speaker
Shreya Davé
Shreya DavéDirector, Pharmacoepidemiology
Takeda Pharmaceuticals Europe
United Kingdom
Bert Van Leeuwen
Bert Van LeeuwenDeputy Qualified Person for Pharmacovigilance (QPPV)
Astellas Pharma Europe
The Netherlands
Rudi Scheerlinck
Rudi Scheerlinck Head Global Drug Safety
Andrew A. Parsons
Andrew A. ParsonsExperienced Scientist, Executive Leader, Coach, Trainer and Supervisor. Co-author of Leading with Presence
United Kingdom
More speakers

Who will you meet?

Senior Pharmacovigilance Regulators and Inspectors, Pharmacovigilance and Drug Safety Officers, Regulatory Affairs Officers, Clinical Risk-Benefit Groups, Local Medicines Authorities, CRO and Consultants providing QPPV Services, Pharma Industry Heads, Directors and Managers OF:

  • Compliance
  •  Drug Safety Officers
  • Global Drug Safety Officers
  • Heads of Safety and Pharmacovigilance
  • Inspection and Audit
  • International PV Auditors
  • Lead Safety Scientists
  • Medical Affairs
  • Patient Safety
  • Pharmacoepidemiology Pharmacovigilance
  • Consultants
  • Pharmacovigilance Managers
  • Pharmacovigilance Team Leaders
  • PSMF
  • PV Quality System
  • QPPV Personnel’s
  • Regulatory Affairs Managers
  • Safety & Risk management Safety
  • Evaluation
  • Safety Surveillance Senior Safety
  • Specialists
  • Signal Detection

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